BACKGROUND:Melasma is a common skin pigment disorder with a difficult clinical response to treatment. OBJECTIVES: To evaluate the clinical efficacy and safety of the association of Belides, Emblica and Licorice 7%, compared to Hydroquinone 2%, in the treatment of melasma. METHODS: After 60 days of exclusive use of an SPF35 sunscreen, 56 women, 18 to 60 years of age, phototypes I to IV, with epidermal or mixed melasma, were divided into two different groups in a mono-blind clinical study: A) cream with Belides, Emblica and Licorice, applied twice a day; B) cream with Hydroquinone 2%, used at night. They were observed in a 60-day study; every 15 days, they were submitted to medical evaluation, self-evaluation, and photographic registration (Visia(®)). RESULTS: 50 volunteers (89%), 23 in Group A and 27 in Group B, concluded the study. Two volunteers in Group A and 7 in Group B had mild skin adverse events. Depigmentation was observed through medical evaluation (Group A: 78.3%; Group B: 88.9%) and volunteers' self-evaluation (Group A: 91.3%; Group B: 92.6%); these results were statistically significant (p<0.001), with no differences between groups (p>0.05). This pattern of results was observed by Visia® in the number (p = 0.001) and size and tone (p<0.001) of the uv stains, for both groups, with no differences between them (p>0.05). CONCLUSION: There were no statistic differences between groups in the improvement of melasma. Group A showed less skin adverse events. Therefore, the association of Emblica, Licorice and Belides is a safe and efficient alternative for the treatment of melasma.
RCT Entities:
BACKGROUND: Melasma is a common skin pigment disorder with a difficult clinical response to treatment. OBJECTIVES: To evaluate the clinical efficacy and safety of the association of Belides, Emblica and Licorice 7%, compared to Hydroquinone 2%, in the treatment of melasma. METHODS: After 60 days of exclusive use of an SPF35 sunscreen, 56 women, 18 to 60 years of age, phototypes I to IV, with epidermal or mixed melasma, were divided into two different groups in a mono-blind clinical study: A) cream with Belides, Emblica and Licorice, applied twice a day; B) cream with Hydroquinone 2%, used at night. They were observed in a 60-day study; every 15 days, they were submitted to medical evaluation, self-evaluation, and photographic registration (Visia(®)). RESULTS: 50 volunteers (89%), 23 in Group A and 27 in Group B, concluded the study. Two volunteers in Group A and 7 in Group B had mild skin adverse events. Depigmentation was observed through medical evaluation (Group A: 78.3%; Group B: 88.9%) and volunteers' self-evaluation (Group A: 91.3%; Group B: 92.6%); these results were statistically significant (p<0.001), with no differences between groups (p>0.05). This pattern of results was observed by Visia® in the number (p = 0.001) and size and tone (p<0.001) of the uv stains, for both groups, with no differences between them (p>0.05). CONCLUSION: There were no statistic differences between groups in the improvement of melasma. Group A showed less skin adverse events. Therefore, the association of Emblica, Licorice and Belides is a safe and efficient alternative for the treatment of melasma.