Abstract | BACKGROUND: Newer agents and formulations seek to improve the tolerability of topical retinoid therapy. Recently, a gel containing crystalline clindamycin 1.2% and tretinoin 0.025% ( CLIN/RA) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of treating mild-to-moderate acne. OBJECTIVE: This single-center, randomized, evaluator-blind phase 1 study compared the tolerability of CLIN/RA to 0.1% tretinoin gel or 0.1% adapalene gel. RESULTS: Forty-five patients applied CLIN/RA once daily to one side of their face every day for 21 days. Patients were randomized to either tretinoin 0.1% (n = 23) or adapalene 0.1% (n = 22) on the contralateral side. A clinical evaluator assessed degree of erythema and scaling; patients provided subjective evaluations of burning, stinging, and itching. CONCLUSION:
CLIN/RA was significantly better tolerated than was 0.1% tretinoin gel, as evidenced by significantly reduced erythema (P < 0.04), scaling (P < 0.03), itching (P < 0.02), burning (P < 0.03) and stinging (P < 0.04). A trend for greater erythema, scaling, and subjective discomfort for 0.1% adapalene gel compared to CLIN/RA was also evident.
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Authors | James Leyden, Mitchell Wortzman, Edward K Baldwin |
Journal | Journal of drugs in dermatology : JDD
(J Drugs Dermatol)
Vol. 8
Issue 4
Pg. 383-8
(Apr 2009)
ISSN: 1545-9616 [Print] United States |
PMID | 19363857
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anti-Bacterial Agents
- Dermatologic Agents
- Drug Combinations
- Gels
- Naphthalenes
- Adapalene
- Clindamycin
- Tretinoin
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Topics |
- Acne Vulgaris
(drug therapy)
- Adapalene
- Adolescent
- Adult
- Anti-Bacterial Agents
(administration & dosage, adverse effects)
- Clindamycin
(administration & dosage, adverse effects)
- Dermatologic Agents
(administration & dosage, adverse effects)
- Drug Combinations
- Female
- Gels
- Humans
- Male
- Microspheres
- Naphthalenes
(administration & dosage, adverse effects)
- Tretinoin
(administration & dosage, adverse effects)
- Young Adult
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