Clindamycin phosphate 1.2%- tretinoin 0.025% gel: vehicle characteristics, stability, and tolerability.
An aqueous gel formulation containing solubilized clindamycin phosphate 1.2% and a stable combination of both solubilized and crystalline tretinoin 0.025% (clin/tret) has been evaluated in 3 pivotal phase 3 studies, among other studies including a 52-week trial. The pivotal studies enrolled 4550 participants 12 years and older with mild, moderate, and severe acne vulgaris. The combination clin/tret gel was effective in reducing both inflammatory and noninflammatory lesions and was well-tolerated. This article reviews important vehicle characteristics of the combination gel as well as formulation stability and tolerability data that are potentially clinically relevant.
Valley Hospital Medical Center, Las Vegas, Nevada, USA.
James Q
JQ
Del Rosso
Waranush
W
Jitpraphai
Sanjay
S
Bhambri
Saira
S
Momin
D000152:Acne Vulgaris / Q000188:drug therapy*; D000279:Administration, Cutaneous; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000494:pharmacology; D001585:Benzoyl Peroxide / Q000494:pharmacology; D002981:Clindamycin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000737:chemistry / Q000494:pharmacology; D017453:Dermatitis, Irritant / Q000209:etiology; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000494:pharmacology; D004338:Drug Combinations; D004347:Drug Interactions; D004355:Drug Stability; D005782:Gels; D006801:Humans; D014677:Pharmaceutical Vehicles / Q000737:chemistry / Q000494:pharmacology; D012869:Skin Absorption; D014212:Tretinoin / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000494:pharmacology
D000900:Anti-Bacterial Agents; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D014677:Pharmaceutical Vehicles; D002981:Clindamycin; D014212:Tretinoin; C007084:clindamycin phosphate; D001585:Benzoyl Peroxide