- Clindamycin phosphate 1.2%- tretinoin 0.025% gel: vehicle characteristics, stability, and tolerability.
Clindamycin phosphate 1.2%- tretinoin 0.025% gel: vehicle characteristics, stability, and tolerability.
Cutis (2008-06-12)
James Q Del Rosso, Waranush Jitpraphai, Sanjay Bhambri, Saira Momin
PMID18543590
ABSTRACT
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.
MATERIALS
Product Number
Brand
Product Description
Clindamycin phosphate, European Pharmacopoeia (EP) Reference Standard
Supelco
Clindamycin Phosphate, Pharmaceutical Secondary Standard; Certified Reference Material
Tretinoin, European Pharmacopoeia (EP) Reference Standard