BACKGROUND: Different immunologic mechanisms contribute to development of inflammation in acne vulgaris and immunologic effect of levamisole has been demonstrated. OBJECTIVE: The aim of this study was to compare azithromycin and levamisole with azithromycin alone in the treatment of acne vulgaris. METHODS: An investigator-blind clinical randomized prospective 2 months study was designed. 169 acne patients presenting in our outpatients clinic were randomly allocated to two treatment groups: azithromycin and levamisole (Group 1) and azithromycin alone (Group 2). 148 patients completed the duration of the study and their clinical responses were evaluated and compared by using monthly photographic records. RESULTS:Mean reduction rates for the number of papules, pustules and both of them, in Group 1 were 73.72%, 82.69% and 76.93%, respectively, and 68.39%, 70.89% and 69.32% in Group 2 (p < 0.05). Also, mean reduction rates for the number of nodules, cysts and both of them in Group 1 were 80.97%, 89.75% and 82.35%, respectively, and 58.54%, 54.55% and 57.99% in Group 2 (p < 0.05).These differences between two groups were statistically significant in favor of azithromycin and levamisole (Group 1) (p < 0.05). CONCLUSION: According to this study azithromycin plus levamisole may be more effective than azithromycin alone in decreasing of inflammatory acne lesions especially in nodulocystic form. So, regarding the low cost and side effect profile of levamisole, we suggest to consider combination of levamisole with azithromycin while facing acne patients at least with more inflammatory lesions especially when there is any contraindication for isotretinoin.
RCT Entities:
BACKGROUND: Different immunologic mechanisms contribute to development of inflammation in acne vulgaris and immunologic effect of levamisole has been demonstrated. OBJECTIVE: The aim of this study was to compare azithromycin and levamisole with azithromycin alone in the treatment of acne vulgaris. METHODS: An investigator-blind clinical randomized prospective 2 months study was designed. 169 acnepatients presenting in our outpatients clinic were randomly allocated to two treatment groups: azithromycin and levamisole (Group 1) and azithromycin alone (Group 2). 148 patients completed the duration of the study and their clinical responses were evaluated and compared by using monthly photographic records. RESULTS: Mean reduction rates for the number of papules, pustules and both of them, in Group 1 were 73.72%, 82.69% and 76.93%, respectively, and 68.39%, 70.89% and 69.32% in Group 2 (p < 0.05). Also, mean reduction rates for the number of nodules, cysts and both of them in Group 1 were 80.97%, 89.75% and 82.35%, respectively, and 58.54%, 54.55% and 57.99% in Group 2 (p < 0.05).These differences between two groups were statistically significant in favor of azithromycin and levamisole (Group 1) (p < 0.05). CONCLUSION: According to this study azithromycin plus levamisole may be more effective than azithromycin alone in decreasing of inflammatory acne lesions especially in nodulocystic form. So, regarding the low cost and side effect profile of levamisole, we suggest to consider combination of levamisole with azithromycin while facing acnepatients at least with more inflammatory lesions especially when there is any contraindication for isotretinoin.
Authors: Amir Feily; Tahere Taheri; Barbara Meier-Schiesser; Dena P Rhinehart; Saeed Sobhanian; Maricarmen Colon-Diaz; Ahmad Feily; Marigdalia K Ramirez-Fort Journal: Int J Womens Dermatol Date: 2019-11-14