A Comparative evaluation of the efficacy and safety of 2% crisaborole versus 0.1% tacrolimus ointment for the topical treatment of mild to moderate atopic dermatitis - nil

Start Date03 Jun 2024

Sponsor / Collaborator-

CTR20241238 / CompletedNot Applicable

克立硼罗软膏(规格：2%，30g/支)在中国健康受试者中空腹外用状态下随机、开放、单次给药、两序列、两周期、双交叉生物等效性临床预试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence pilot study of crisaborole ointment (specification: 2%, 30 g/tube) in Chinese healthy subjects under fasting condition

主要研究目的：观察中国健康受试者空腹状态下单次外用受试制剂克立硼罗软膏4g（规格：2%，30g/支）和参比制剂克立硼罗软膏4g（商品名：舒坦明®/Staquis®；规格：2%，30g/支；持证商：Anacor Pharmaceuticals Inc）后的药代动力学特征，初步评价空腹外用状态下两种制剂的生物等效性。次要研究目的：观察空腹外用受试制剂克立硼罗软膏和参比制剂克立硼罗软膏（舒坦明®/Staquis®）在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to observe the pharmacokinetic characteristics of the test preparation crisaborole ointment 4g (specification: 2%, 30g/tube) and the reference preparation crisaborole ointment 4g (trade name: Sutanming®/Staquis®; specification: 2%, 30g/tube; licensee: Anacor Pharmaceuticals Inc) after single topical application in Chinese healthy subjects under fasting state, and preliminarily evaluate the bioequivalence of the two preparations under fasting topical state. Secondary purpose of the study is to observe the safety of the test preparation crisaborole ointment and the reference preparation crisaborole ointment (Sutantamine®/Staquis®) in Chinese healthy subjects after fasting topical application.

Start Date07 May 2024

Sponsor / Collaborator

Youhua Medical Technology Co., Ltd.

CTR20241182 / CompletedNot Applicable

克立硼罗软膏在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、两序列、双交叉空腹生物等效性试验

[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence, double-crossover fasting bioequivalence study of crisaborole ointment in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，比较在空腹状态下外用受试制剂克立硼罗软膏（持证商：福建省宝诺医药研发有限公司）与参比制剂克立硼罗软膏（持证商：Anacor Pharmaceuticals, Inc.，商品名：舒坦明®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：（1）观察受试制剂克立硼罗软膏和参比制剂克立硼罗软膏在健康受试者中的安全性；（2）评价受试制剂克立硼罗软膏与参比制剂克立硼罗软膏对中国健康受试者的皮肤反应性。

[Translation]

Primary objective: To compare the pharmacokinetic behavior of the test preparation crisaborole ointment (licensed by: Fujian Baonuo Pharmaceutical Research and Development Co., Ltd.) and the reference preparation crisaborole ointment (licensed by: Anacor Pharmaceuticals, Inc., trade name: Sutanming®) in healthy subjects after external application under fasting state, using pharmacokinetic parameters as the primary endpoint evaluation index, and to evaluate the bioequivalence of the two preparations. Secondary objectives: (1) To observe the safety of the test preparation crisaborole ointment and the reference preparation crisaborole ointment in healthy subjects; (2) To evaluate the skin reactivity of the test preparation crisaborole ointment and the reference preparation crisaborole ointment in healthy Chinese subjects.

Start Date07 May 2024

Sponsor / Collaborator

Fujian Boro Pharmaceutical Research Co., Ltd.

100 Clinical Results associated with Crisaborole

100 Translational Medicine associated with Crisaborole

100 Patents (Medical) associated with Crisaborole

167

Literatures (Medical) associated with Crisaborole

01 Feb 2024·Dermatitis : contact, atopic, occupational, drug

Impact of Crisaborole in Treatment-Experienced Patients With Mild-to-Moderate Atopic Dermatitis

Article

Author: Tom, Wynnis L ; Zang, Chuanbo ; Sanders, Paul ; Shi, Vivian ; Vlahos, Bonnie ; Stein Gold, Linda F ; Cha, Amy

Background: Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of patients with mild-to-moderate atopic dermatitis (AD). Objective: To assess the efficacy and safety of crisaborole in patients with AD who had received prior treatment with (a) corticosteroids (systemic or topical) or topical calcineurin inhibitors (TCIs) or (b) topical corticosteroids (TCSs) or TCIs or (c) who were treatment-naive (TN). Methods: This post hoc analysis comprised patients aged ≥2 years with mild-to-moderate AD. Patients were assigned (2:1) to receive crisaborole or vehicle twice daily for 28 days. Patient response was assessed with the Investigator's Static Global Assessment (ISGA), Dermatology Life Quality Index (DLQI), Children's Dermatology Life Quality Index (CDLQI), and Dermatitis Family Impact (DFI) tools. Safety was also assessed. Results: A significantly higher percentage of patients treated with crisaborole versus vehicle achieved ISGA success regardless of treatment history. Patients treated with crisaborole had significant reductions in DLQI, CDLQI, and DFI scores versus those who received vehicle regardless of treatment history, with the exception of DLQI and DFI scores in the TN group. Crisaborole was well tolerated in all subgroups. Conclusion: Crisaborole demonstrated a favorable efficacy and safety profile in both treatment-experienced and TN patients. ClinicalTrials.gov, NCT02118766 and NCT02118792.

01 Jan 2024·European journal of pharmacology

ME3183, a novel phosphodiesterase-4 inhibitor, exhibits potent anti-inflammatory effects and is well tolerated in a non-clinical study

Article

Author: Tabata, Yuji ; Kaji, Chizuko ; Wakabayashi, Tsubasa ; Matsumoto, Shogo ; Kubota-Ishida, Natsuki ; Isshiki, Satoshi ; Okura, Iori ; Kumura, Ko ; Cho, Naoki ; Matsuhira, Takashi

Phosphodiesterase 4 (PDE4) inhibitors are expected to exhibit efficacy against inflammatory diseases due to their broad pharmacological activity. The launched PDE4 inhibitors apremilast, crisaborole, and roflumilast have not exhibited sufficient inhibitory potential due to poor margins of effectiveness and tolerability. In this report, we describe the non-clinical efficacy, brain translocation, and vomit-inducing effects of ME3183 compared with apremilast. ME3183 showed extensive cytokine suppression in vitro studies using human peripheral blood mononuclear cells and T cells. ME3183 also significantly suppressed skin inflammation in a chronic oxazolone-induced dermatitis model and showed antipruritic effects in a substance P-induced mouse pruritus model. In these in vitro and in vivo studies, ME3183 also significantly suppressed cytokines, and focusing on tumor necrosis factor-α as a psoriasis-related cytokine and interleukin-4 as an atopic dermatitis-related cytokine, ME3183 potently inhibited both cytokines. ME3183 showed in vivo efficacy at lower doses than apremilast. The brain distribution of ME3183 was sufficiently low in mice and rats. The effective dose of ME3183 for emesis was similar to that of apremilast in ferrets. Given its high-potency inhibitory effects, ME3183 would have a wide margin of efficacy and tolerability. These wide margins demonstrate the effectiveness of ME3183 in treating many inflammatory diseases, such as psoriasis and atopic dermatitis. An on-going phase 2 trial is expected to further demonstrate the efficacy and safety of ME3183.

01 Dec 2023·The Journal of allergy and clinical immunology

Topical treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials

Review

Author: Izcovich, Ariel ; Wang, Julie ; Basmaji, John ; Zhao, Irene X ; Pérez-Herrera, Lucia C ; Smith Begolka, Wendy ; Boguniewicz, Mark ; Martin, Stephen A ; Lio, Peter A ; Islam, Nazmul ; MacDonald, Margaret ; Sadeghirad, Behnam ; Silverberg, Jonathan I ; Chen, Lina ; Gao, Ya ; Wheeler, Kathryn E ; Schneider, Lynda ; Ong, Peck Y ; Spergel, Jonathan M ; Frazier, Winfred T ; O'Brien, Monica ; Wong, Melanie M ; Ceccacci, Renata ; Chu, Derek K ; Chu, Xiajing ; Yepes-Nuñez, Juan José ; Gardner, Donna D ; Brignardello-Petersen, Romina ; Huynh, Joey ; Capozza, Korey ; Greenhawt, Matthew ; Gomez-Escobar, Luis ; Chu, Alexandro W L ; Díaz Martinez, Juan Pablo ; Ellison, Kathy ; De Benedetto, Anna ; Rayner, Daniel G ; Asiniwasis, Rachel N ; Guyatt, Gordon H ; LeBovidge, Jennifer

BACKGROUND:

Atopic dermatitis (AD) is a common skin condition with multiple topical treatment options, but uncertain comparative effects.

OBJECTIVE:

We sought to systematically synthesize the benefits and harms of AD prescription topical treatments.

METHODS:

For the 2023 American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma, and Immunology Joint Task Force on Practice Parameters AD guidelines, we searched MEDLINE, EMBASE, CENTRAL, CINAHL, LILACS, ICTRP, and GREAT databases to September 5, 2022, for randomized trials addressing AD topical treatments. Paired reviewers independently screened records, extracted data, and assessed risk of bias. Random-effects network meta-analyses addressed AD severity, itch, sleep, AD-related quality of life, flares, and harms. The Grading of Recommendations Assessment, Development and Evaluation approach informed certainty of evidence ratings. We classified topical corticosteroids (TCS) using 7 groups-group 1 being most potent. This review is registered in the Open Science Framework (https://osf.io/q5m6s).

RESULTS:

The 219 included trials (43,123 patients) evaluated 68 interventions. With high-certainty evidence, pimecrolimus improved 6 of 7 outcomes-among the best for 2; high-dose tacrolimus (0.1%) improved 5-among the best for 2; low-dose tacrolimus (0.03%) improved 5-among the best for 1. With moderate- to high-certainty evidence, group 5 TCS improved 6-among the best for 3; group 4 TCS and delgocitinib improved 4-among the best for 2; ruxolitinib improved 4-among the best for 1; group 1 TCS improved 3-among the best for 2. These interventions did not increase harm. Crisaborole and difamilast were intermediately effective, but with uncertain harm. Topical antibiotics alone or in combination may be among the least effective. To maintain AD control, group 5 TCS were among the most effective, followed by tacrolimus and pimecrolimus.

CONCLUSIONS:

For individuals with AD, pimecrolimus, tacrolimus, and moderate-potency TCS are among the most effective in improving and maintaining multiple AD outcomes. Topical antibiotics may be among the least effective.

News (Medical) associated with Crisaborole

29 Aug 2023

·www.fiercepharma.com

Arcutis launches branded Zoryve ad for a 'Cream That Can' as it eyes streaming services for new campaign

Arcutis Biotherapeutics is looking to compete against Amgen's blockbuster rival Otezla. One year after receiving FDA approval, Arcutis Biotherapeutics is launching the first direct-to-consumer ad campaign for its plaque psoriasis therapy Zoryve. The non-steroid drug competes with Amgen's blockbuster Otezla, which generates more than $2 billion annually and has multiple indications. Otezla was the first pill approved for plaque psoriasis. Arcutis aims to distinguish Zoryve from both topical steroids and Otezla by emphasizing its easier method of administration, which can cover all skin areas. This is in contrast to steroidal creams, which may pose safety risks with prolonged use. This focus is evident in its advertisements The commercial features a simple black background with a central focus on people's naked bodies (without showing their faces). A narrator asks, "For plaque psoriasis, why can't there be a steroid-free topical I can use for as long as I need?" Then a new voice comes in, adding: “A cream I can apply, just once a day,” playing on the “Cream That Can” tagline for the campaign. The "Cream That Can" ad will “air across many of the top on-demand video streaming platforms,” the company said in a release, rather than a full focus on TV. Zoryve (roflumilast) works a topical formulation of the PDE4 inhibitor found in AstraZeneca’s chronic obstructive pulmonary disease treatment Daliresp. The psoriasis med crossed the FDA finish line last August, and Arcutis has been ramping up the unbranded awareness campaigns for the dermatology condition before this new DTC. In September 2022, just weeks after the green light for the med, it launched the “Expose Psoriasis” online educational campaign designed to improve the understanding of plaque psoriasis' physical and emotional impact. It also aimed to raise awareness that symptoms may occur anywhere on the body including knees, elbows, torso and sensitive places like the face and genitals. Before that, in April 2022, Arcutis had also released a survey from the Harris Poll that found 75% of people with psoriasis in intertriginous areas, or skin folds, reported a negative impact on their emotional well-being. “The Cream That Can helps make clear skin the hero. No matter where plaque psoriasis may appear on the skin, whether in hard-to-treat areas like knees and elbows, or sensitive areas like the face and skin folds, Zoryve is the cream that can help,” said Ayisha Jeter, interim chief commercial officer at Arcutis, in a press release. Arcutis is hoping to do better than Pfizer’s Eucrisa, which was set to be the next big topical treatment for inflammatory skin diseases, but the ointment never gained traction in psoriasis thanks to side effects and reimbursement hurdles. But Mizuho analysts are bullish on Zoryve's prospects, which works differently to Eucrisa, and believes the Arcutis med can, with other approvals, hit peak annual sales of between $1.8 billion and $3.8 billion in 2030. In the current psoriasis treatment landscape, next-gen biologics such as Novartis’ Cosentyx, Eli Lilly’s Taltz and AbbVie’s Skyrizi have demonstrated remarkable efficacy in psoriasis. But in an interview with Fierce Pharma last year, Arcutis CEO Frank Watanabe said Zoryve isn’t positioned as a competitor to the biologics but rather as being complementary to them.

Drug Approval

12 Jan 2023

·www.prnewswire.com

AMERICAN ACADEMY OF DERMATOLOGY ISSUES UPDATED GUIDELINES FOR THE MANAGEMENT OF ATOPIC DERMATITIS IN ADULTS WITH TOPICAL THERAPIES

Both well-established and newer topical treatments addressed ROSEMONT, Ill., Jan. 12, 2023 /PRNewswire/ -- Often called eczema or atopic eczema, atopic dermatitis is a common skin condition, affecting 1 in 10 Americans1. Although atopic dermatitis occurs most frequently in children, it also affects adults and can have a significant impact on patients' quality of life. To help ensure that adult patients with atopic dermatitis receive the best possible treatment, the American Academy of Dermatology (AAD) has published updated guidelines of care for the management of atopic dermatitis in adults with topical therapies in the Journal of the American Academy of Dermatology. Continue Reading This is the second in a series of updated guidelines the AAD is producing on the condition. The updates, which outline best practices for topical treatment of the disease, were developed by an expert workgroup of 12 physicians, including 11 dermatologists, an allergist/pediatrician and one patient representative. The AAD published updated guidelines of care for the management of atopic dermatitis in adults with topical therapies Tweet this "Atopic dermatitis is the most common type of eczema, and it can interfere with a person's daily life without proper treatment," said board-certified dermatologist Robert Sidbury, MD, MPH, FAAD, co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "The guidelines provide evidence-based recommendations for dermatologists to use in caring for their adult atopic dermatitis patients with topical treatments, which have come a long way since the guidelines were last revised in 2014. This update reflects the latest advances in topical medications that are now available to help adults with atopic dermatitis." Atopic dermatitis can develop on any area of your skin at any age. Adults who have atopic dermatitis often have red to dark patches and scaly skin. They also can have extremely dry skin, hand eczema, eye problems, and skin that is easily irritated. "While atopic dermatitis cannot be cured, it can be controlled with proper treatment," said Dr. Sidbury. "A plan created by a board-certified dermatologist can help ease symptoms, reduce flare-ups, and prevent it from worsening. Topical treatments remain one of the most popular options due to their effective track record and overall safety." The Atopic Dermatitis Workgroup developed 12 recommendations on how to manage atopic dermatitis in adults with topical therapies. The workgroup provided new recommendations for non-prescription methods as well as prescription treatments. Strong recommendations were made for topical treatments in which the benefits clearly outweigh the risks and burdens to the patient. These recommendations apply to most patients in most circumstances. Strong recommendations were made for the use of the following: Moisturizers help to relieve patients' dry, cracked skin, decrease inflammation, and reduce the severity of and increase the time between flare-ups. Topical calcineurin inhibitors (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment) reduce patients' inflammation and itching, as well as decrease their flare-ups. Topical corticosteroids are commonly used as the first-line treatment for patients with atopic dermatitis in all skin regions. They help to relieve itching, decrease inflammation, and can decrease infections. Phosphodiesterase-4 inhibitor (crisaborole ointment) can reduce patients' inflammation, help relieve itching, and decrease infections. Janus kinase inhibitor (ruxolitinib cream) can be used short term to ease the inflammation and itching of patients with mild to moderate atopic dermatitis. The guidelines provide conditional recommendations for the use of bathing and wet wrap therapy. Conditional recommendations apply to most patients, but the most appropriate action may differ depending on individual patient factors. Bathing, followed by moisturization , helps patients hydrate the skin. Bleach baths can help patients prevent infection and get rid of bacteria on their skin. Wet wrap therapy utilizes wet bandages to help hydrate and soothe patients' skin. This treatment provides a barrier against scratching, helps to decrease redness and inflammation, and can reduce the bacteria on patients' skin. "These recommendations are based on the latest evidence-based research on the most effective topical treatments for our patients," said Dawn Davis, MD, FAAD, co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "These recommended treatments can be used individually or in combination with other treatments." The guidelines made conditional recommendations against the use of topical antimicrobials, antiseptics, and antihistamines due to the low certainty of evidence, which means the true effect may be substantially different from the estimated effect. "These guidelines were updated to enable dermatologists to optimize topical treatments to provide adult atopic dermatitis patients with expert care," said board-certified dermatologist Mark D. Kaufmann MD, FAAD, president of the AAD. "Since each patient's atopic dermatitis is unique, board-certified dermatologists can determine the treatments that will work best for them. I'm very grateful to our workgroup for providing these important updates to help patients worldwide." To find a board-certified dermatologist in your area, visit aad.org/findaderm. More information: Eczema Types: Atopic Dermatitis Overview Eczema Types: Atopic Dermatitis Symptoms Guidelines of care for the management of atopic dermatitis in adults with topical therapies About the AAD 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 20,000 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, Pinterest and YouTube and @AADskin1 on Instagram. About JAAD The Journal of the American Academy of Dermatology is the most widely read dermatology journal in the world, according to Kantar Media. JAAD was the first most-cited dermatology journal in 2021, according to impact factor rankings from Clarivate's Journal Citation Reports (JCR) Web of Science Group. JAAD also has two open-access companion titles: JAAD Case Reports and JAAD International. Follow @JAADJournals on Facebook, Twitter, and Instagram. SOURCE American Academy of Dermatology

12 Jan 2023

·www.biospace.com

American Academy of Dermatology Issues Updated Guidelines for the Management of Atopic Dermatitis in Adults With Topical Therapies

Both well-established and newer topical treatments addressed ROSEMONT, Ill., Jan. 12, 2023 /PRNewswire/ -- Often called eczema or atopic eczema, atopic dermatitis is a common skin condition, affecting 1 in 10 Americans1. Although atopic dermatitis occurs most frequently in children, it also affects adults and can have a significant impact on patients' quality of life. To help ensure that adult patients with atopic dermatitis receive the best possible treatment, the American Academy of Dermatology (AAD) has published updated guidelines of care for the management of atopic dermatitis in adults with topical therapies in the Journal of the American Academy of Dermatology. The AAD published updated guidelines of care for the management of atopic dermatitis in adults with topical therapies This is the second in a series of updated guidelines the AAD is producing on the condition. The updates, which outline best practices for topical treatment of the disease, were developed by an expert workgroup of 12 physicians, including 11 dermatologists, an allergist/pediatrician and one patient representative. "Atopic dermatitis is the most common type of eczema, and it can interfere with a person's daily life without proper treatment," said board-certified dermatologist Robert Sidbury, MD, MPH, FAAD, co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "The guidelines provide evidence-based recommendations for dermatologists to use in caring for their adult atopic dermatitis patients with topical treatments, which have come a long way since the guidelines were last revised in 2014. This update reflects the latest advances in topical medications that are now available to help adults with atopic dermatitis." Atopic dermatitis can develop on any area of your skin at any age. Adults who have atopic dermatitis often have red to dark patches and scaly skin. They also can have extremely dry skin, hand eczema, eye problems, and skin that is easily irritated. "While atopic dermatitis cannot be cured, it can be controlled with proper treatment," said Dr. Sidbury. "A plan created by a board-certified dermatologist can help ease symptoms, reduce flare-ups, and prevent it from worsening. Topical treatments remain one of the most popular options due to their effective track record and overall safety." The Atopic Dermatitis Workgroup developed 12 recommendations on how to manage atopic dermatitis in adults with topical therapies. The workgroup provided new recommendations for non-prescription methods as well as prescription treatments. Strong recommendations were made for topical treatments in which the benefits clearly outweigh the risks and burdens to the patient. These recommendations apply to most patients in most circumstances. Strong recommendations were made for the use of the following: Moisturizers help to relieve patients' dry, cracked skin, decrease inflammation, and reduce the severity of and increase the time between flare-ups. Topical calcineurin inhibitors (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment) reduce patients' inflammation and itching, as well as decrease their flare-ups. Topical corticosteroids are commonly used as the first-line treatment for patients with atopic dermatitis in all skin regions. They help to relieve itching, decrease inflammation, and can decrease infections. Phosphodiesterase-4 inhibitor (crisaborole ointment) can reduce patients' inflammation, help relieve itching, and decrease infections. Janus kinase inhibitor (ruxolitinib cream) can be used short term to ease the inflammation and itching of patients with mild to moderate atopic dermatitis. The guidelines provide conditional recommendations for the use of bathing and wet wrap therapy. Conditional recommendations apply to most patients, but the most appropriate action may differ depending on individual patient factors. Bathing, followed by moisturization, helps patients hydrate the skin. Bleach baths can help patients prevent infection and get rid of bacteria on their skin. Wet wrap therapy utilizes wet bandages to help hydrate and soothe patients' skin. This treatment provides a barrier against scratching, helps to decrease redness and inflammation, and can reduce the bacteria on patients' skin. "These recommendations are based on the latest evidence-based research on the most effective topical treatments for our patients," said Dawn Davis, MD, FAAD, co-chair of the AAD's Atopic Dermatitis Guideline Workgroup. "These recommended treatments can be used individually or in combination with other treatments." The guidelines made conditional recommendations against the use of topical antimicrobials, antiseptics, and antihistamines due to the low certainty of evidence, which means the true effect may be substantially different from the estimated effect. "These guidelines were updated to enable dermatologists to optimize topical treatments to provide adult atopic dermatitis patients with expert care," said board-certified dermatologist Mark D. Kaufmann MD, FAAD, president of the AAD. "Since each patient's atopic dermatitis is unique, board-certified dermatologists can determine the treatments that will work best for them. I'm very grateful to our workgroup for providing these important updates to help patients worldwide." To find a board-certified dermatologist in your area, visit aad.org/findaderm. More information: Eczema Types: Atopic Dermatitis Overview Eczema Types: Atopic Dermatitis Symptoms Guidelines of care for the management of atopic dermatitis in adults with topical therapies About the AAD 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 20,000 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, Pinterest and YouTube and @AADskin1 on Instagram. About JAAD The Journal of the American Academy of Dermatology is the most widely read dermatology journal in the world, according to Kantar Media. JAAD was the first most-cited dermatology journal in 2021, according to impact factor rankings from Clarivate's Journal Citation Reports (JCR) Web of Science Group. JAAD also has two open-access companion titles: JAAD Case Reports and JAAD International. Follow @JAADJournals on Facebook, Twitter, and Instagram. View original content: SOURCE American Academy of Dermatology

100 Deals associated with Crisaborole

External Link

KEGG	Wiki	ATC	Drug Bank
D10873	Crisaborole	D11AH06	DB05219

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Dermatitis, Atopic	US	Anacor Pharmaceuticals LLC	14 Dec 2016

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Vitiligo	Phase 2	US	Pfizer Inc.	07 Sep 2022
Dermatitis	Phase 2	US	Pfizer Inc.	26 Jun 2020
Skin Ulcer	Phase 2	US	Pfizer Inc.	26 Jun 2020
Alopecia Areata	Phase 2	US	Pfizer Inc.	06 Mar 2020
Plaque psoriasis	Phase 2	MX	Pfizer Inc.	01 Sep 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04040192 (CrisADe CONTROL, Pubmed)	Phase 3	Dermatitis, Atopic Maintenance	-	Crisaborole QD	ivnuyuagwf(kyqmypayva) = median time to ISGA response was 41.5 days crsbinvfjb (hpnhguwijm )	-	28 Mar 2024
				Vehicle
NCT04040192 (CrisADe CONTROL, EADV2023)	Phase 3	Dermatitis, Atopic	497	Crisaborole BID	ltmmwerwkz(oqotfgoimq) = zahdccsfgk hevccnnlii (qrplmrkvox, 48.7 - 64.0)	Positive	11 Oct 2023
NCT04040192 (CrisADe CONTROL, EADV2023)	Phase 3	Dermatitis, Atopic Maintenance	497	Crisaborole QD	gsmdnqmmcs(trhlrpludt) = dlfuprxhwp wqoitrzbwo (rinzfstxea ) View more	-	11 Oct 2023
				Vehicle QD	gsmdnqmmcs(trhlrpludt) = kyndlbaqes wqoitrzbwo (rinzfstxea ) View more
WCD2023	Not Applicable	Tracheitis	13	Crisaborole	dxchygdhjc(hthwxkkcxi) = yxxlynskee jgpiqloweu (ebhibxotca ) View more	Positive	07 Jul 2023
NCT04194814 (WCD2023)	Phase 2	Dermatitis, Atopic	37	Betamethasone valerate	iavgcandds(vprdgpnmhw) = veerxhfdso kehvqfjwbn (pfgstmbkds, 14.93, 20.86)	-	03 Jul 2023
WCD2023	Not Applicable	Dermatitis, Atopic	-	Crisaborole	lzgjqykqct(ramymfubtm) = tzvbhozdcp kemsiidoxq (eeczfhxsav )	-	03 Jul 2023
				Vehicle	zobiltoriv(vpfmcnszxr) = kagvkhspif cdfvgtgndd (bahdqjogvn ) View more
NCT04040192 (CrisADe CONTROL, Pubmed)	Phase 3	Dermatitis, Atopic Maintenance	497	Crisaborole QD	nyxlkzaofa(qblrnqxgwi) = iaroonqwdj ybkyixapgr (sytufezwlx )	Positive	15 May 2023
				Vehicle QD	nyxlkzaofa(qblrnqxgwi) = ydqsfdcbwm ybkyixapgr (sytufezwlx )
NCT04040192 (CrisADe CONTROL, CTgov)	Phase 3	Dermatitis, Atopic	620	crisaborole (Vehicle QD)	kupczyfhkn(urykvobjxd) = abmhykxihf hxvvopumja (whkplzmymg, ayntpstnhb - selyqntokr) View more	-	08 Mar 2023
				Crisaborole (Crisaborole 2% QD)	kupczyfhkn(urykvobjxd) = ouepnhmqhn hxvvopumja (whkplzmymg, fdeftbtlhk - praknvghhq) View more
NCT04091087 (CTgov)	Phase 2	Skin Ulcer \| Dermatitis	66	vehicle ointment	wlzzemnrgj(afyrmmjclu) = phclpopgts lmpshukrbm (wutlsvhxdb, ovszhhdwgh - osbrabuoxy) View more	-	02 May 2022
NCT02118766 \| NCT02118792 (AD-301 \| AD-302, Pubmed \| Paediatr Drugs) Manual	Phase 3	Dermatitis, Atopic	1,313	Crisaborole	nvuorqjzwc(mipgkkxqcz) = vppikubcso yyqjhvqiqd (izameqpoew ) View more	Superior	01 Mar 2022
				received vehicle	nvuorqjzwc(mipgkkxqcz) = ejnjuuczor yyqjhvqiqd (izameqpoew ) View more

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