A RANDOMIZED, PARALLEL GROUP, OPEN LABEL, ACTIVE CONTROLLED CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF A TOPICAL UNANI FORMULATION WITH ADAPALENE (0.1 percent) IN THE MANAGEMENT OF BUTHUR LABANIYYA (ACNE VULGARIS) - NIL

Start Date01 Jun 2025

Sponsor / Collaborator-

IRCT20241028063523N4

/ RecruitingPhase 4IIT

Comparative efficacy of combined treatment with ketoconazole 2% cream and adapalene 0.1% gel versus ketoconazole 2% cream monotherapy in pityriasis versicolor.

Start Date19 Nov 2024

Sponsor / Collaborator-

NCT06141330

/ RecruitingNot ApplicableIIT

Vitamin D Supplementation in Combination With Azithromycin and Topical Retinoid for Acne: A Randomized Controlled Trial

The goal of this clinical trial is to compare in acne vulgaris patients. The main question it aims to answer is:
• To assess the therapeutic benefit of vitamin D supplement in acne vulgaris treatment, following a 2-month treatment regimen that includes vitamin D supplementation compared to conventional (systemic azithromycin and topical retinoid) treatment alone.
Participants will receive vitamin D supplements in addition to capsule Azithromycin and topical retinoid.
Researchers will compare groups to determine efficacy of Vitamin D supplements in the treatment of Acne vulgaris.

Start Date24 Feb 2024

Sponsor / Collaborator-

100 Clinical Results associated with Adapalene

100 Translational Medicine associated with Adapalene

100 Patents (Medical) associated with Adapalene

1,064

Literatures (Medical) associated with Adapalene

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Efficacy and safety of fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel in Hispanic participants with moderate-to-severe acne: a pooled analysis

Article

Author: Callender, Valerie D. ; Cook-Bolden, Fran E. ; Alexis, Andrew F. ; Guenin, Eric ; Gold, Linda Stein ; Baldwin, Hilary

INTRODUCTION:

Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination approved for acne. In phase 2 and 3 studies, CAB demonstrated superior efficacy to vehicle and component dyads. This post hoc analysis examined efficacy/tolerability of CAB in 147 self-identified Hispanic/Latino participants (referred to as Hispanic).

METHODS:

Data were pooled from one phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) double-blind, 12-week studies. Eligible participants aged ≥9 years with moderate to severe acne were randomized to once-daily CAB or vehicle. Endpoints included ≥2-grade reduction from baseline in Evaluator's Global Severity Score with clear/almost clear skin (treatment success) and inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were assessed.

RESULTS:

At week 12, 56.2% of CAB-treated participants achieved treatment success vs 18.4% with vehicle (p < 0.001). Reductions in inflammatory/noninflammatory lesions were 77.1%/76.2% with CAB vs 56.4%/45.0% with vehicle, respectively (p < 0.001, all). CAB TEAE rates were similar to overall study populations (27.0% vs 24.6%-36.2%). Baseline hyperpigmentation scores decreased from 0.6 to 0.3 (1 = mild) at week 12 with CAB. CAB gel was efficacious, safe, and well tolerated in Hispanic participants. Limitations include lack of Fitzpatrick skin phototype and short study duration.

CONCLUSIONS:

This study provides support for acne treatment with CAB in ethnically diverse populations.

01 May 2025·Journal of Drugs in Dermatology

Clindamycin Phosphate 1.2%/Adapalene 0.15%/ Benzoyl Peroxide 3.1% for Acne: Results From A 6-Month Open-Label Study

Article

Author: Tanghetti, Emil A. ; Draelos, Zoe Diana ; Stein Gold, Linda ; Ghannoum, Mahmoud ; Baldwin, Hilary ; Guenin, Eric ; Harper, Julie C.

BACKGROUND:

Treatment of acne may require many months of treatment before maximal benefits are observed, and acne sequelae (eg, scarring, dyspigmentation) can persist long after lesion resolution. In 12-week clinical trials, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) demonstrated efficacy and tolerability in the treatment of moderate to severe acne. This study assessed CAB long-term efficacy/tolerability and reductions in acne scarring/dyspigmentation.

METHODS:

This 24-week, single-center, open-label study assessed once-daily CAB in participants (N=25) aged ≥12 years with moderate acne (Investigator’s Global Assessment [IGA] score=3). Endpoints included change from baseline in IGA score, inflammatory/noninflammatory lesions, skin appearance (dryness, postinflammatory hyperpigmentation [PIH], and postinflammatory erythema [PIE]), and scarring. Tolerability parameters (itching, burning, redness, swelling) and adverse events were assessed. At baseline and week 24, participants’ foreheads were swabbed to assess Cutibacterium acnes. Results: At week 24, 68% of participants achieved treatment success (≥2-grade IGA score reduction from baseline and clear/almost clear skin), and significant inflammatory/noninflammatory lesion reductions from baseline were observed (89%; 70%; P<0.001, both). Decreases from baseline in investigator- and participant-assessed PIH (77%; 82%) and PIE (84%; 88%) and investigator-assessed scarring severity (33%) were statistically significant (P≤0.001, all). There were no significant increases in skin dryness or any tolerability parameter, and no adverse events occurred. C. acnes assessment indicated no development of antibiotic resistance with long-term CAB treatment. Conclusions: With 24 weeks of once-daily use, CAB was efficacious, well-tolerated, and significantly improved acne-related scarring and dyspigmentation. These results support the long-term use of CAB in the topical treatment of acne. Citation: Draelos ZD, Ghannoum M, Stein Gold L, et al. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% for acne: results from a six-month open-label study. J Drugs Dermatol. 2025;24(5):516-523. doi:10.36849/JDD.9018.

01 May 2025·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Dendrobium polysaccharide-based microneedles loaded with Celosia cristata flavonoids and adapalene nanoparticles for efficacious treatment of acne vulgaris

Article

Author: Pang, Shuqin ; Xu, Keming ; Zhong, Wenying ; Hao, Shiqi ; Li, Fanglin ; Lei, Wenwen ; Liu, Yuanyuan

Acne vulgaris is a common chronic inflammatory skin disorder primarily caused by the overgrowth of Propionibacterium acnes (P. acnes). However, the therapeutic efficacy of traditional drugs is often limited due to their inability to penetrate the stratum corneum. Microneedles (MNs) are designed to penetrate the stratum corneum, enabling direct drug delivery to the epidermis. In this study, a new Dendrobium polysaccharide-based composite microneedle (DOP/CCF/PLGA@Adap-MN) delivery system was developed. Dendrobium polysaccharide (DOP) was utilized as the microneedle matrix, loaded with the Celosia cristata flavonoids (CCF) and poly(lactic-co-glycolic acid) adapalene nanoparticles (PLGA@Adap NPs). DOP not only enhanced the mechanical properties and transdermal efficiency of the microneedles but also provided intrinsic anti-inflammatory activity. CCF effectively inhibited the growth of P. acnes, while PLGA@Adap NPs slowly released adapalene to promote acne healing. In vivo studies using a P. acnes-induced mice model demonstrated that this microneedle system effectively reduced skin swelling, inhibited bacterial growth, and decreased inflammatory cell numbers in the skin. The use of bioactive DOP as a microneedle matrix, combined with sustained-release technology, provides a multifaceted and synergistic approach to acne treatment.

News (Medical) associated with Adapalene

25 Oct 2024

·www.prnewswire.com

Studies Show Sun Pharma's WINLEVI® (clascoterone) Cream 1% Reduces Sebum Levels and is Suitable for Combination With Other Commonly Used Topical Acne Medications

WINLEVI poster presentations at 2024 Fall Clinical Dermatology Conference also include data affirming reduced acne severity and tolerability in patients with skin of color. MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries or associate companies), today presented data strengthening the clinical rationale for the use of WINLEVI ® (clascoterone) cream 1% to treat acne. In poster presentations at the 44th Annual Fall Clinical Dermatology Conference, data show WINLEVI significantly reduces sebum (oil) production and demonstrates excellent stability in the presence of other commonly prescribed topical acne treatments, supporting the use of WINLEVI in combination with those medications. Data also showed patients with skin of color, an under-represented population in studies of acne medications, experienced reduced acne severity and tolerability while taking WINLEVI. Collectively, the data continue to show that WINLEVI improves acne severity and is well tolerated. "As we learn more about the importance of sebum as a main cause of acne, it is gratifying to see new data supporting the use of WINLEVI to reduce sebum production as well as its suitability for combination treatment with other commonly prescribed topical agents," said Abhay Gandhi, chief executive officer, North America at Sun Pharma. "We are also encouraged by the reported reductions in acne severity and tolerability in people with skin of color, for whom the impact of acne can be profound. Together, these latest studies further establish WINLEVI as a safe and effective acne medication that dermatology professionals can confidently prescribe to their patients." WINLEVI is the first and only androgen receptor inhibitor indicated for the topical treatment of acne vulgaris (acne) in patients 12 years of age and older, and the first and only FDA-approved topical treatment available in the U.S. that targets sebum production in the skin. Sebum is an oily wax that protects and moisturizes skin, but too much of it feeds bacteria inside the skin, causing inflammation and acne lesions. Acne is the most prevalent skin condition in the U.S., affecting up to 50 million Americans and 80% of people at some point during their lives.1,2 It is the most common dermatological disorder in Black/African American and Hispanic/Latino populations.3 WINLEVI cream is a topical prescription medicine to treat acne in people 12 and older. The most common side effects include reddening, scaling or dryness, and itching. Local irritation may occur. Sebum reduction data Researchers presented 12-week interim results from a yearlong study of the effect of WINLEVI on facial sebum production in patients with acne. The study's primary objective and efficacy endpoint was reduction in casual facial sebum levels, as measured by a sebumeter, a device that directly measures the amount of lipids on the skin's surface. The study was also designed to assess the ability of WINLEVI to reduce the Investigator's Global Assessment (IGA) score, a scale designed for investigators to assess the level of facial acne (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe). Other study objectives and efficacy endpoints included inflammatory and noninflammatory acne lesion counts, and investigator-assessed oily appearance, pore size, and facial shine; the latter three endpoints were assessed on a five-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe). Among the 40 participating patients, the mean age was 20.9 years; most patients were female (60%) and White (63%). All patients entered the study with mild (57.5%) or moderate (42.5%) acne, as well as a mean sebumeter reading of 115.9 ± 50.5. The researchers reported significant reductions in sebumeter measurements following use of WINLEVI at six (-22%, P = 0.002), 10 (-19%, P = 0.005), and 12 weeks (-27%, P <0.001). They also observed significant improvements in facial oily appearance after four weeks of WINLEVI treatment (-8%, P = 0.008), with continued improvement through 12 weeks (-40%, P <0.001). Similarly, patients' pore size improved significantly after six weeks (-13%, P = 0.002), and continued to improve through 12 weeks (-23%, P <0.001). Additionally, facial shine levels significantly improved after four weeks (-9%, P = 0.004) with continued improvement through 12 weeks (-39%, P <0.001). By Week 12, patients using WINLEVI experienced a statistically significant 29% reduction in IGA score (P <0.001). Use of WINLEVI also resulted in significant reductions in the numbers of inflammatory and noninflammatory lesions (-48% and -40%, respectively; P <0.001 for both measurements) after four weeks, with continued improvement through 12 weeks (-54% and -34%, respectively; P <0.001 for both). WINLEVI was well tolerated through Week 12, with no reports of adverse reactions. "This is exciting news for people living with acne because this is the first study to demonstrate a reduction in measured facial sebum production following the use of clascoterone cream 1%," said lead investigator Zoe D. Draelos, MD, of Dermatology Consulting Services, PLLC, in High Point, N.C. "In addition to confirming the sebum-reducing effect of WINLEVI, our findings support data from previous clinical trials which showed reductions in the number of inflammatory and noninflammatory lesions, further demonstrating the clinical utility of this topical acne medication." Stability in combination therapy data Dr. Draelos and colleagues also reported results from a study assessing the stability of WINLEVI when layered with other topical acne medications such as tretinoin cream 0.025%, adapalene gel 0.3%, dapsone gel 7.5%, azelaic acid 15%, benzoyl peroxide 5%/clindamycin 1%, benzoyl peroxide 2.5%/adapalene 0.1%, and benzoyl peroxide encapsulated 5%. Each of these medications were placed separately on individual microscope slides with WINLEVI and incubated for eight hours at 37° Celsius. Material from the slides was extracted for analysis via high-performance liquid chromatography-mass spectrometry (HPLC-MS). WINLEVI concentrations remained stable after layering with other acne medications. The percentage of WINLEVI recovered after layering ranged from 98% to 119%, indicating that none of the acne medications evaluated induced degradation of WINLEVI when used in combination. "Multimodal topical therapy, incorporating products with multiple mechanisms of action to target multiple mechanisms of disease, has become standard practice in the treatment of acne," commented Dr. Draelos. "In this in vitro study, WINLEVI demonstrated consistent and reproducible stability in the presence of other acne medications. Our findings support the combination of WINLEVI with topical retinoids, topical antibiotics, and/or benzoyl peroxide as a viable acne treatment strategy and complement the encouraging results observed in the sebum reduction and skin of color trials." Skin of Color Data A separate team of researchers presented 16-week interim results from a 56-week, single-center, open-label pilot study evaluating the efficacy and safety of WINLEVI in 10 patients (mean age 24 years) with skin of color (Fitzpatrick skin types IV, V, and VI) and moderate-to-severe facial acne. The study met its primary endpoint, with seven (78%) patients achieving an IGA score of 0 (clear) or 1 (almost clear) at Week 16 (P = 0.008 vs. baseline). The study also met its secondary endpoints at Week 16, including significant reductions in inflammatory (91.8%, P = 0.008), noninflammatory (90.9%, P = 0.009), and total lesions (90.9%, P = 0.009). Investigator- and participant-assessed tolerability parameters were absent or minimal at most time points through Week 16. There were no reports of adverse events during the 16-week interim analysis period. For complete prescribing information please click here. INDICATION WINLEVI (clascoterone) cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream. Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with WINLEVI. In the pharmacokinetics (PK) trial, HPA axis suppression was observed in 1/20 (5%) of adult subjects and 2/22 (9%) of adolescent subjects at Day 14. All subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. Attempt to withdraw use if HPA axis suppression develops. Pediatric patients may be more susceptible to systemic toxicity. Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. Shifts from normal to elevated potassium levels were observed in 5% of WINLEVI-treated subjects and 4% of vehicle-treated subjects. ADVERSE REACTIONS Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle. About Sun Pharmaceutical Industries Limited. (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing Sun Pharma's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. Sun Pharma does not undertake any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. References 1 Skin conditions by the numbers. American Academy of Dermatology Association, 2021. Available at Skin conditions by the numbers (aad.org). Accessed January 11, 2023. 2 Collier CN, Harper JC, Cafardi JA, et al. The prevalence of acne in adults 20 years and older. J Am Acad Dermatol. 2008;58(1):56-59. 3 Taylor SC. Epidemiology of skin diseases in people of color. Cutis. 2003;71(4):271-275. SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug Approval

23 Aug 2024

·pharma.economictimes.indiatimes.com

Govt bans 156 medicines including antibiotics, painkillers, multivitamins: Here is the full list

New Delhi: In a significant move aimed at safeguarding public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs, including a variety of antibiotics, painkillers, multivitamins, and medications for treating fever and hypertension. This decision marks the largest crackdown on FDCs since 2016, when 344 such drugs were prohibited. The Union Ministry of Health and Family Welfare issued a gazette notification on Thursday, officially prohibiting the manufacture, sale, and distribution of the banned FDCs. The ban was based on the recommendations of an expert panel that reviewed a total of 324 FDCs. Impact on Pharmaceutical Industry The banned FDCs include popular combinations such as mefenamic acid and paracetamol injections, commonly used for pain relief and fever, and omeprazole magnesium with dicyclomine HCl, used to treat abdominal pain. The ban is expected to impact major pharmaceutical companies, including Sun Pharmaceuticals, Cipla, Dr. Reddy's Laboratories, Torrent Pharmaceuticals, and Alkem Laboratories. Fixed Dose Combinations Drug Banned List Here is a table listing all 156 banned Fixed Dose Combinations (FDCs) SN Fixed Dose Combination (FDC) 1 Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain 2 Antimony Potassium Tartrate + Dried Ferrous Sulphate 3 Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride 4 Bismuth Ammonium Citrate + Papain 5 Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide 6 Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride 7 Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide 8 Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol 9 Mefenamic Acid + Paracetamol Injection 10 Omeprazole Magnesium + Dicyclomine HCl 11 S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L- Methylfolate + Choline bitartratee + Silymarin + L-ornithine Laspartate + Inositol + Taurine 12 Silymarin + Thiamine Mononitrate + Riboflavin + Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12 13 Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid 14 Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate 15 Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol 16 Sucralfate + Acelofenac 17 Sucralfate + Domperidone + Dimethicone 18 Sucralfate + Domperidone 19 Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol 20 Ursodeoxycholic Acid + Metformin HCl 21 Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit + Chloroform + Sodium Bicarbonate + Compound Cardamom + Alcohol 22 Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate 23 Aloe + Vitamin E Soap 24 Povidone Iodine+ Metronidazole + Aloe 25 Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles 26 Azithromycin + Adapalene 27 Calamine + Aloes + Allantoin 28 Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor 29 Chlorphenesin + Zinc oxide + Starch 30 Clindamycin Phosphate + Zinc acetate 31 Gamma Benzene Hexachloride + Benzocaine 32 Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin 33 Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w 34 Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes 35 Ketoconazole +Aloe vera+ Vitamin A Acetate 36 Ketoconazole +Aloes + ZPTO 37 Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry 38 Lornoxicam +capsaicin +menthol+ camphor 39 Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate 40 Menthol + Aloe vera Topical Spray 41 Menthol +Lignocaine HCl +Aloe vera gel +Clotrimazole +Diphenhydramine 42 Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate 43 Miconazole +Tinidazole 44 Minoxidil +Aminexil+ Alcohol 45 Minoxidil +Azelaic acid + saw palmetto 46 Minoxidil +Aminexil 47 Pine Bark extract+ Kojic acid +Sodium Ascorbyl Phosphate 48 Povidone Iodine +Tinidazole +Zinc sulphate 49 Povidone Iodine + Ornidazole + Dexpanthenol 50 Salicyclic acid +Aloe vera+ Allantoin +D-Panthenol 51 Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate 52 Sodium salicylate + Zinc gluconate + Pyridoxine HCl 53 Tetracycline + Colistin Sulphate 54 Clomiphene +Ubidecarenone 55 Combikit of Clomiphene Citrate + Estradiol Valerate 56 Flavoxate HCl +Ofloxacin 57 Clomiphene Citrate +N-Acetylcysteine 58 Primerose Oil +Cod liver oil 59 Sildenafil Citrate +Papaverine +L-Arginine 60 Tranexamic acid +Mefenamic acid + Vitamin K1 61 Divalproex Sodium +Oxcarbazepine 62 Divalproex Sodium + Levetiracitam 63 Ergotamine tartrate +Caffeine + Paracetamol +Prochlorperazine maleate 64 Piracetam + Ginkgo biloba extracts + Vinpocetin 65 Ginkgo biloba + methylcobalamin 66 Ginkgo biloba + methylcobalamin + Alpha lipoic acid +Pyridoxine HCl 67 Ginseng Extract +Dried extract of Ginkgo Biloba 68 Meclizine HCl+ Paracetamol + Caffeine 69 Nicergoline + Vinpocetine 70 Gamma Linolenic Acid + Methylcobalamin 71 Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl 72 Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor 73 Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose 74 Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 75 Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose 76 Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl 77 Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine 78 Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose 79 Ketorolac Tromethamine + Flurometholone 80 Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate 81 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor 82 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate SN Fixed Dose Combination (FDC) 83 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Menthol + Camphor 84 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 85 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Methylparaben 86 Methenamine + Sodium Benzoate + Benzyl Alcohol 87 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 88 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate + Caffeine 89 Propoxyphene + Chlorpheniramine Maleate 90 Propoxyphene + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 91 Propoxyphene + Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride 92 Sodium Benzoate + Sodium Citrate + Citric Acid 93 Vitamin A Palmitate + Vitamin C + Vitamin E + Vitamin B6 + Vitamin B12 94 Vitamin A Palmitate + Vitamin C + Vitamin E + Niacinamide 95 Vitamin B6 + Vitamin B12 + Vitamin C 96 Vitamin B6 + Vitamin B12 + Niacinamide 97 Vitamin B12 + Vitamin B6 + Vitamin C + Folic Acid 98 Vitamin B12 + Vitamin B6 + Niacinamide + Folic Acid 99 Vitamin C + Vitamin E + Vitamin A + Niacinamide 100 Vitamin D + Calcium + Magnesium 101 Vitamin D + Calcium + Magnesium + Zinc 102 Calcium + Vitamin D + Vitamin K 103 Calcium + Vitamin D + Magnesium + Zinc 104 Calcium + Vitamin D + Vitamin K + Magnesium 105 Calcium + Vitamin D + Vitamin K + Magnesium + Zinc 106 Vitamin E + Vitamin A + Vitamin C + Niacinamide 107 Vitamin E + Vitamin A + Vitamin C + Folic Acid 108 Vitamin E + Vitamin A + Vitamin C + Biotin 109 Vitamin E + Vitamin A + Vitamin C + Vitamin B12 110 Vitamin E + Vitamin C + Folic Acid 111 Vitamin E + Vitamin C + Biotin 112 Vitamin E + Vitamin C + Vitamin B12 113 Vitamin E + Vitamin C + Zinc 114 Calcium + Vitamin D + Omega-3 Fatty Acids 115 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K 116 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Magnesium 117 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Zinc 118 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene 119 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene + Zinc 120 Vitamin C + Vitamin E + Beta-Carotene 121 Vitamin C + Vitamin E + Beta-Carotene + Zinc 122 Vitamin C + Vitamin E + Selenium 123 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids 124 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Magnesium 125 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Zinc 126 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Biotin 127 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 128 Vitamin E + Vitamin A + Vitamin C + Zinc 129 Vitamin E + Vitamin A + Vitamin C + Selenium 130 Vitamin E + Vitamin A + Vitamin C + Biotin 131 Vitamin E + Vitamin A + Vitamin C + Folic Acid + Niacinamide 132 Vitamin E + Vitamin C + Beta-Carotene + Zinc 133 Vitamin C + Vitamin E + Biotin + Folic Acid 134 Vitamin C + Vitamin E + Beta-Carotene + Folic Acid 135 Vitamin C + Vitamin E + Beta-Carotene + Selenium 136 Vitamin E + Vitamin C + Beta-Carotene + Biotin 137 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Biotin 138 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 139 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B12 140 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B6 141 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Folate 142 Calcium + Vitamin D + Magnesium + Vitamin K + Omega-3 Fatty Acids 143 Calcium + Vitamin D + Magnesium + Vitamin K + Biotin 144 Calcium + Vitamin D + Magnesium + Vitamin K + Selenium 145 Calcium + Vitamin D + Magnesium + Vitamin K + Vitamin B12 146 Calcium + Vitamin D + Magnesium + Vitamin K + Folate 147 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B6 148 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B12 149 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Folic Acid 150 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Biotin 151 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Selenium 152 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids 153 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Zinc 154 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Biotin 155 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Selenium 156 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Vitamin B12

Drug Approval

31 Jan 2024

·www.prnewswire.com

AMERICAN ACADEMY OF DERMATOLOGY ISSUES UPDATED GUIDELINES FOR THE MANAGEMENT OF ACNE

Both newly approved and well-established treatments recommended ROSEMONT, Ill., Jan. 31, 2024 /PRNewswire/ -- Acne is the most common skin condition in the United States, affecting nearly 50 million Americans each year, with symptoms usually beginning in puberty. Acne affects 85% of adolescents and can also often begin or continue in adulthood, especially in women. To help ensure that people with acne get the best possible treatment, the American Academy of Dermatology (AAD) has published updated guidelines of care for the management of acne in adults, adolescents, and children over the age of 9 in the Journal of the American Academy of Dermatology. Continue Reading "These guidelines provide important updates to the 2016 AAD acne guidelines, including discussion of new topical medications, which are directly applied to the skin, and systemic treatments, which are taken by mouth," said board-certified dermatologist John S. Barbieri, MD, MBA, FAAD, co-chair of the AAD's Acne Guideline Workgroup. "This update provides evidence-based recommendations for dermatologists and other clinicians caring for patients with acne." Acne affects 85% of adolescents and can also often begin or continue in adulthood, especially in women. Post this Updates to the management of acne vulgaris provides 18 evidence-based recommendations for topical, systemic, and physical treatment methods, including newly approved therapeutic options, and 5 good practice statements. Strong recommendations were made for the use of the following: Topical benzoyl peroxide to reduce the amount of acne-causing bacteria on the skin. Topical retinoids (e.g. adapalene, tretinoin, tazarotene, trifarotene) to help unclog pores and reduce inflammation. Oral antibiotics, such as oral doxycycline, and topical antibiotics to reduce the amount of acne-causing bacteria on the skin and lessen inflammation. Combinations of topical benzoyl peroxide, retinoids, or the above antibiotics. Employing best practices in guideline development, the multidisciplinary workgroup also issued 5 good practice statements. When managing acne with topical medications, the guidelines recommend combining multiple different treatment types, as this can lead to better results. The guidelines recommend limiting use of oral antibiotics when possible to reduce the development of antibiotic resistance and other antibiotic-associated complications. It is recommended that topical and oral antibiotics are used simultaneously with benzoyl peroxide to prevent the development of antibiotic resistance. For patients with larger acne bumps, the guidelines recommend injectable corticosteroids as a potential option for more rapid relief of inflammation and pain. For patients with severe acne or for patients who have failed standard treatment with oral or topical therapy, the guidelines recommend isotretinoin. Additionally, the guidelines provide conditional recommendations. Conditional recommendations apply to most patients, but the most appropriate action may differ depending on individual patient factors. Topical clascoterone, which addresses hormonal causes of acne. Topical salicylic acid to unclog pores and exfoliate the skin. Topical azelaic acid to unclog pores, kill bacteria, and fade dark spots that may continue when an acne spot clears. Oral minocycline or sarecycline to reduce the amount of acne-causing bacteria on the skin and lessen inflammation. Hormonal therapies such as combined oral contraceptives or spironolactone to address hormonal causes of acne. Available evidence was insufficient to develop recommendations for procedures such as chemical peels, laser and light-based devices, microneedling, as well as for dietary changes, or alternative therapies such as vitamins or plant-based products. Additionally, a conditional recommendation against adding broadband light, intense pulsed light, to adapalene 0.3% gel. "Board-certified dermatologists are on the forefront of new and exciting advances in the treatment of acne," said Dr. Barbieri. "We are able to offer our patients with acne more options than ever before as we work to address their concerns and determine the most effective treatment plan possible. Just as important, dermatologists must have access to all available therapeutic options." Since there are a variety of treatment options for acne and treatment plans are not one-size-fits-all, it is important to partner with a board-certified dermatologist to decide which options work best for you. To find a board-certified dermatologist in your area, visit aad.org/findaderm. More Information Acne resource center Acne treatment AAD B-Roll Library About the AAD Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 20,800 physicians worldwide, the AAD is committed to advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education and research in dermatology; and supporting and enhancing patient care because skin, hair, and nail conditions can have a serious impact on your health and well-being. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org. Follow @AADskin on Facebook, TikTok, Pinterest and YouTube and @AADskin1 on Instagram. SOURCE American Academy of Dermatology

100 Deals associated with Adapalene

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KEGG	Wiki	ATC	Drug Bank
D01112	Adapalene	D10AD03	DB00210

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Approved

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Indication	Country/Location	Organization	Date
Acne Vulgaris	United States	Galderma Laboratories LP	31 May 1996

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Photodamaged skin	Phase 3	Brazil	Galderma Brasil Ltda.	01 Jan 2013
Skin aging	Phase 3	Brazil	Galderma Brasil Ltda.	01 Jan 2013
Severe acne	Phase 3	United States	Galderma Holding SA	01 Aug 2008
Severe acne	Phase 3	Canada	Galderma Holding SA	01 Aug 2008
Severe acne	Phase 3	Puerto Rico	Galderma Holding SA	01 Aug 2008
Atrophic acne scar	Phase 2	United States	Galderma Holding SA	01 Mar 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03615768 (CACTUS, Pubmed) Manual	Phase 3	Acne Vulgaris	1,617	Adapalene-clindamycin gel	jkotjrmzeg(oeiqcnqbfc) = klkkwtuckb yczbyvrmsb (nupbuububx ) View more	Positive	01 Nov 2024
				Adapalene gel	jkotjrmzeg(oeiqcnqbfc) = sjrvbjbqaf yczbyvrmsb (nupbuububx ) View more
NCT00422240 (CTgov)	Phase 3	Acne Vulgaris	1,668	Adapalene/Benzoyl Peroxide (Adapalene/Benzoyl Peroxide Gel)	rjtatbnxpf = nqvdulhgzp bfqrvbbvcp (nhkrtlrfcy, cdguzsylcn - acnvyvjqyx) View more	-	15 Apr 2024
				Adapalene Gel, 0.1% (Adapalene Gel, 0.1%)	rjtatbnxpf = vghpxkqimi bfqrvbbvcp (nhkrtlrfcy, hkkmqkwwjl - fjziebzazv) View more
AAD2023	Not Applicable	-	-	Adapalene 0.1% gel	kvsrazmgmu(iydalparyf) = tqntnwhvbx bkxbodgvxo (vertgaruxd ) View more	-	17 Mar 2023
				Tretinoin	kvsrazmgmu(iydalparyf) = lzgmvokovr bkxbodgvxo (vertgaruxd ) View more
EADV2022	Not Applicable	Moderate to severe acne	47	Dapsone 7.5% gel	rtowrsksdx(iqjemukdew) = pmgelkuxkf zlgnctqgxv (ntcwwtvcyo ) View more	Positive	12 May 2022
				Adapalene 0.1% gel	rtowrsksdx(iqjemukdew) = xjcjudtbtp zlgnctqgxv (ntcwwtvcyo ) View more
NCT03393494 (CTgov)	Phase 3	Acne Vulgaris	825	Adapalene+Benzoyl Peroxide Topical Gel (Perrigo Active)	lwgbiicpyx(yezvplhwke) = rcucsjqyvm tzqmdonezn (fwxcxcbkqf, 28.96) View more	-	05 Jan 2021
				Epiduo Topical Product (Reference Active)	lwgbiicpyx(yezvplhwke) = qspdwbucrm tzqmdonezn (fwxcxcbkqf, 31.57) View more
ERS2018	Not Applicable	Skin Diseases First line EGFR-activating mutations	-	Adapalene	jyfyvljkpw(fxomdgixdh) = zccmigrufo mxehxgwflt (axundktnmr )	Positive	15 Sep 2018
				Erlotinib+TNF-a+IL-1b	jyfyvljkpw(fxomdgixdh) = atjphdfoqi mxehxgwflt (axundktnmr )
NCT00671749 (CTgov)	Phase 4	Acne Vulgaris	100	Differin+Duac	bmuztfxbev(xrnecwlqis) = cxhczzmpvg ofclgmpqbt (tgoceotixi, 24.43) View more	-	16 Mar 2016
NCT01213199 (CTgov)	Phase 2	Atrophic acne scar	20	Differin	dskmdgzvnz(udqnsnlhcw) = lwpizbwwpd fekqtddsfw (dbukdegoka, 0.8) View more	-	23 Mar 2015
NCT00829049 (CTgov)	Phase 4	Acne Vulgaris	165	Tazarotene Cream 0.1% (Tazarotene Cream 0.1%)	vtvniqlhlo(riayiibwjd) = myjcgawrij ykqdsuztuw (ecylabngud, qyxfsqacjh - ptijxzgije) View more	-	12 Sep 2012
				Adapalene (Adapalene Gel 0.3%)	vtvniqlhlo(riayiibwjd) = qzottbhpno ykqdsuztuw (ecylabngud, qtnlhvlxwo - aondwasbmb) View more
NCT01231334 (CTgov)	Phase 4	Acne Vulgaris	286	adapalene+Dapsone (Aczone® Gel 5% Plus Differin® 0.3% Gel)	dpmhlhslqa = rsdfqeaayy yqeceucdwi (mfzrqitunf, dijlkiyibw - hkrjrhltvd) View more	-	27 Jul 2012
				Adapalene+Dapsone (Duac® Topical Gel Plus Differin® 0.3% Gel)	dpmhlhslqa = phhfwhmivz yqeceucdwi (mfzrqitunf, ziynkfcwhy - cdcfpacnmv) View more

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