BACKGROUND:Topical retinoids are considered first-line therapy in the treatment of acne vulgaris, yet can be associated with cutaneous irritations. Combination therapy with natural preparations could be effective in treatment and decreasing adverse events. OBJECTIVE: The aim of this study was to compare the efficacy and safety of the combination of tretinoin (TR) cream (0.05%) and Aloe vera topical gel (50%) with TR and vehicle. MATERIAL AND METHODS: The randomized, double-blind, prospective 8-week trial evaluated inflammatory and non-inflammatorylesion scores and tolerability in 60 subjects with mild to moderate acne vulgaris (global acne grading system scale). RESULTS: Several formulations of A. vera leaf gel were prepared and the most stable one was selected for clinical study based on physicochemical evaluations. The combination therapy showed superior efficacy to TR and placebo. TR/Aloe vera gel (AVG) was significantly more effective in reducing non-inflammatory (p = 0.001), inflammatory (p = 0.011) and total (p = 0.003) lesion scores than control group. The highest percentage of adverse cutaneous effect was reported for scaling. At the end of study, erythema in the TR/AVG-treated group was significantly less severe (p = 0.046). CONCLUSION: The combination TR/AVG was well tolerated and significantly more effective than TR and vehicle for the treatment of mild to moderate acne vulgaris.
RCT Entities:
BACKGROUND: Topical retinoids are considered first-line therapy in the treatment of acne vulgaris, yet can be associated with cutaneous irritations. Combination therapy with natural preparations could be effective in treatment and decreasing adverse events. OBJECTIVE: The aim of this study was to compare the efficacy and safety of the combination of tretinoin (TR) cream (0.05%) and Aloe vera topical gel (50%) with TR and vehicle. MATERIAL AND METHODS: The randomized, double-blind, prospective 8-week trial evaluated inflammatory and non-inflammatory lesion scores and tolerability in 60 subjects with mild to moderate acne vulgaris (global acne grading system scale). RESULTS: Several formulations of A. vera leaf gel were prepared and the most stable one was selected for clinical study based on physicochemical evaluations. The combination therapy showed superior efficacy to TR and placebo. TR/Aloe vera gel (AVG) was significantly more effective in reducing non-inflammatory (p = 0.001), inflammatory (p = 0.011) and total (p = 0.003) lesion scores than control group. The highest percentage of adverse cutaneous effect was reported for scaling. At the end of study, erythema in the TR/AVG-treated group was significantly less severe (p = 0.046). CONCLUSION: The combination TR/AVG was well tolerated and significantly more effective than TR and vehicle for the treatment of mild to moderate acne vulgaris.