Delving into the Latest Updates on Clindamycin Phosphate/Tretinoin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Veltin, Ziana

Target

50S subunit x RARα x RARβ2 x RARγ

Action

inhibitors, agonists

Mechanism

50S subunit inhibitors(50S ribosomal subunit inhibitors), RARα agonists(Retinoic acid receptor alpha agonists), RARβ2 agonists(Retinoic acid receptor beta agonists)

+ [1]

Therapeutic Areas

Skin and Musculoskeletal Diseases

Active Indication

Acne Vulgaris

Inactive Indication-

Originator Organization

Medicis Pharmaceutical Corp.

Active Organization

Almirall LLCViatris Pty Ltd.Bausch Health US LLC

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (07 Nov 2006),

Acne Vulgaris

Regulation-

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Structure/Sequence

Molecular FormulaC38H62ClN2O10PS

InChIKeyRRZFQNYMUQPMHE-HYEGCIPRSA-N

CAS Registry337954-93-5

IMPORTANCEDescribing the relationship between the availability of free prescription drug samples and dermatologists' prescribing patterns on a national scale can help inform policy guidelines on the use of free samples in a physician's office.OBJECTIVESTo investigate the relationships between free drug samples and dermatologists' local and national prescribing patterns and between the availability of free drug samples and prescription costs.DESIGN, SETTING, AND PARTICIPANTSCross-sectional study investigating prescribing practices for acne, a common dermatologic condition for which free samples are often available. The settings were, first, the offices of nationally representative dermatologists from the National Disease and Therapeutic Index (an IMS Health Incorporated database) and, second, an academic medical center clinic without samples. Participants were ambulatory patients who received a prescription from a dermatologist for a primary initial diagnosis of acne vulgaris or rosacea in 2010.MAIN OUTCOMES AND MEASURESNational trends in dermatologist prescribing patterns, the degree of correlation between the availability of free samples and the prescribing of brand-name medications, and the mean cost of acne medications prescribed per office visit nationally and at an academic medical center without samples.RESULTSOn a national level, the provision of samples with a prescription by dermatologists has been increasing over time, and this increase is correlated (r = 0.92) with the use of the branded generic drugs promoted by these samples. Branded and branded generic drugs comprised most of the prescriptions written nationally (79%), while they represented only 17% at an academic medical center clinic without samples. Because of the increased use of branded and branded generic drugs, the national mean total retail cost of prescriptions at an office visit for acne was conservatively estimated to be 2 times higher (approximately $465 nationally vs $200 at an academic medical center without samples).CONCLUSIONS AND RELEVANCEFree drug samples can alter the prescribing habits of physicians away from the use of less expensive generic medications. The benefits of free samples in dermatology must be weighed against potential negative effects on prescribing behavior and prescription costs.

01 Jan 2014·Journal of drugs in dermatology : JDD

The phototoxic and photoallergy potential of clindamycin phosphate 1.2%/ tretinoin 0.025% gel for facial acne: results of two single-center, evaluator-blinded, randomized, vehicle-controlled phase 1 studies in healthy volunteers.

Article

Author: Murray, John ; Potts, Aaron

BACKGROUNDA fixed-dose combination of clindamycin phosphate 1.2% and tretinoin 0.025% gel (VELTIN® (clindamycin phosphate and tretinoin) 1.2%/0.025% Gel [VELTIN]) (clindamycin/tretinoin gel) is currently available for the once-daily topical treatment of acne.OBJECTIVESTwo-phase I studies were conducted to evaluate the phototoxic and photoallergic potential of clindamycin/tretinoin gel.METHODSStudy 1 (phototoxic) (n=37) and Study 2 (photoallergic) (n=58) were single-center, evaluator-blinded, randomized, vehicle-controlled, phase 1 studies conducted in healthy volunteers. In Study 1, clindamycin/tretinoin gel patches, vehicle gel patches and blank patches (no gel) were applied concurrently for 24 hours to naïve sites. After patch removal, sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) then 0.75 minimal erythema dose (MED) of UVA/ultraviolet B light (UVB), the same irradiation protocol followed by 15 joules/cm2 of visible light (VIS), or served as non-irradiated controls. Study 2 examined the effect of repeated drug exposure and involved an induction period (6 repeat phases at the same body sites during which clindamycin/tretinoin gel and vehicle gel patches were applied for 24 hours, removed and sites irradiated with UVB +/- VIS), followed by a rest period (10 to 17 days), then a challenge period that used the protocol described for Study 1. In both studies, inflammatory responses and other cutaneous effects were evaluated at 1, 24, 48, and 72 hours after patch removal.RESULTSNo subject experienced any adverse events in Study 1 (phototoxic). One subject in Study 2 (photoallergic) experienced AEs (diffuse erythema; mild application site irritation at one each of UV/VIS-irradiated clindamycin/tretinoin gel and vehicle gel patch sites) considered definitely related to study product that resulted in discontinuation from the study. Data from Study 1 and the challenge phase from Study 2 showed most subjects had no visible inflammatory reaction to clindamycin/tretinoin gel after irradiation.CONCLUSIONSClindamycin/tretinoin gel has a favorable safety profile following UV/visible irradiation and a low potential for phototoxicity and photoallergenicity.

01 Jun 2012·Int. Journal of Clinical Pharmacology and TherapeuticsQ4 · MEDICINE

Low intrinsic drug activity and dominant vehicle (placebo) effect in the topical treatment of acne vulgaris

Q4 · MEDICINE

Article

Author: Chiou, Win L

In drug treatment for acne, topical products alone or in combination with systemic products are commonly prescribed. It was recently pointed out by Chiou that oral tetracyclines, the most commonly prescribed systemic drugs, may not be as effective as commonly assumed because the effect of placebo can approach drug effects during the 4 - 12 weeks of daily administration. The present work evaluated the percent contribution of vehicle (placebo) toward the reported efficacy of reduction in total (inflammatory and non-inflammatory) lesion counts of 8 commonly prescribed topical preparations at the end of 10 - 12 weeks of daily administration. These preparations included 0.1% tretinoin, 0.1% adapalene, 5% dapsone, 1% clindamycin, a combination of benzoyl peroxide with adapalene or clindamycin, and a clindamycin-tretinoin combination. The mean reduction from drugs and vehicles were 42 ± 7.1%, and 23 ± 5.0%, respectively; the mean contribution of vehicle toward drug effect was 55 ± 15% (range 35 - 82%). For 5 benzoyl peroxide preparations evaluated (2 for 2.5%, and 3 for 5.0%), their respective means were 40 ± 9%, and 25 ± 15%, and vehicle-toward-drug contribution was 58 ± 31% (range 9 - 89%). The present work shows the great importance of vehicle effects in topical therapy; in some cases this effect approached 90%. The potential significance of the above findings in the development of more effective topical anti-acne drugs was discussed.

100 Deals associated with Clindamycin Phosphate/Tretinoin

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Acne Vulgaris	United States	Bausch Health US LLC	07 Nov 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01047189 (CTgov)	Phase 4	Acne Vulgaris	26	clindamycin phosphate+Ziana gel+tretinoin (Ziana Gel)	glsnhxofwn(ovjmmnqhlt) = ktgfmctpte rrwippzira (aelurgtdqe, splnkxbvzn - bkwedwvgvl) View more	-	17 Oct 2011
				Tretinoin+Clindamycin (Clindamycin Plus Tretinoin Applied Separately)	glsnhxofwn(ovjmmnqhlt) = zdghzkbmop rrwippzira (aelurgtdqe, byoynevzwl - dlpwmrmafj) View more
NCT00891982 (CTgov)	Phase 3	Acne Vulgaris	60	CLINDAMYCIN PHOSPHATE/TRETINOIN+Benzoyl Peroxide (CTGel Plus BPO Wash)	djhcubggfn(mzvaaikusy) = wphlpxtdrm scdirwzmmg (xghybtckez, xqkpygzhbt - hudetlqoxl) View more	-	25 Jul 2011
				CTGel (CTGel)	djhcubggfn(mzvaaikusy) = fdhjxqlnsd scdirwzmmg (xghybtckez, ornnjzkljc - dqodexwqyk) View more