BACKGROUND: Acne vulgaris affects individuals of all races and ethnicities. Understanding the safety and efficacy of topical agents benefits the practicing clinician when treating patients with skin of color. PURPOSE: To report observations in acne patients representing all six Fitzpatrick skin types based on a Phase 3 study that evaluated the efficacy and safety of a clindamycin phosphate 1.2% tretinoin 0.025% gel versus a clindamycin phosphate 1.2% gel alone. METHODS: The two treatments were compared in a randomized, double-blind, multicenter, parallel, 12-week study employing a total of 2,010 patients with moderate-to-severe acne. Primary efficacy endpoints were 1) treatment success defined as percentage of patients who were clear or almost clear or achieved at least a 2-grade improvement in Evaluators Global Severity Scores at Week 12 and 2) percent change from baseline versus 12-week scores for noninflamed, inflamed, and total lesions. RESULTS: The 12-week, 37.8-percent Evaluators Global Severity Scores treatment success for clindamycin phosphate 1.2% tretinoin 0.025% gel was greater than the 31.7 percent observed for clindamycin phosphate 1.2% gel alone (P = 0.002). Percent changes from baseline versus 12-week scores for noninflamed, inflamed, and total lesions obtained with clindamycin phosphate 1.2% tretinoin 0.025% gel (49.8, 60.9, and 54.5%, respectively) were significantly greater than those observed for clindamycin phosphate 1.2% gel alone (41.3, 54.8, and 46.9%, respectively); all comparisons P<0.001. CONCLUSION: Use of clindamycin phosphate 1.2% tretinoin 0.025% gel resulted in greater percent reductions of Evaluators Global Severity Scores treatment success scores and acne lesions in patients with all six Fitzpatrick skin types combined than clindamycin phosphate 1.2% gel alone. Both products were well tolerated, with no hypo- or hyperpigmentation noted. Side effects observed were similar to those previously reported for the individual ingredients.
RCT Entities:
BACKGROUND:Acne vulgaris affects individuals of all races and ethnicities. Understanding the safety and efficacy of topical agents benefits the practicing clinician when treating patients with skin of color. PURPOSE: To report observations in acnepatients representing all six Fitzpatrick skin types based on a Phase 3 study that evaluated the efficacy and safety of a clindamycin phosphate 1.2% tretinoin 0.025% gel versus a clindamycin phosphate 1.2% gel alone. METHODS: The two treatments were compared in a randomized, double-blind, multicenter, parallel, 12-week study employing a total of 2,010 patients with moderate-to-severe acne. Primary efficacy endpoints were 1) treatment success defined as percentage of patients who were clear or almost clear or achieved at least a 2-grade improvement in Evaluators Global Severity Scores at Week 12 and 2) percent change from baseline versus 12-week scores for noninflamed, inflamed, and total lesions. RESULTS: The 12-week, 37.8-percent Evaluators Global Severity Scores treatment success for clindamycin phosphate 1.2% tretinoin 0.025% gel was greater than the 31.7 percent observed for clindamycin phosphate 1.2% gel alone (P = 0.002). Percent changes from baseline versus 12-week scores for noninflamed, inflamed, and total lesions obtained with clindamycin phosphate 1.2% tretinoin 0.025% gel (49.8, 60.9, and 54.5%, respectively) were significantly greater than those observed for clindamycin phosphate 1.2% gel alone (41.3, 54.8, and 46.9%, respectively); all comparisons P<0.001. CONCLUSION: Use of clindamycin phosphate 1.2% tretinoin 0.025% gel resulted in greater percent reductions of Evaluators Global Severity Scores treatment success scores and acne lesions in patients with all six Fitzpatrick skin types combined than clindamycin phosphate 1.2% gel alone. Both products were well tolerated, with no hypo- or hyperpigmentation noted. Side effects observed were similar to those previously reported for the individual ingredients.
Authors: S M Bulengo-Ransby; C E Griffiths; C K Kimbrough-Green; L J Finkel; T A Hamilton; C N Ellis; J J Voorhees Journal: N Engl J Med Date: 1993-05-20 Impact factor: 91.245
Authors: Joel Schlessinger; Alan Menter; Michael Gold; Craig Leonardi; Lawrence Eichenfield; R Todd Plott; James Leyden; Mitchell Wortzman Journal: J Drugs Dermatol Date: 2007-06 Impact factor: 2.114