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.
Del Rosso
James Q
JQ
Valley Hospital Medical Center, Las Vegas, Nevada, USA.
Jitpraphai
Waranush
W
Bhambri
Sanjay
S
Momin
Saira
S
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