Comparison of Efficacy of Azithromycin and Levamisole Versus of Azithromycin in in the Treatment of Acne

Study Overview
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Brief Summary
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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.

Detailed Description
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An investigator blind clinical randomized prospective two months study was designed. One hundred sixty nine acne patients presenting in our outpatients clinic were randomly allocated to two treatment groups: azithromycin and levamisole ( group 1 ) and azithromycin alone ( group 2 ) .One hundred forty eight patients completed the duration of the study and their clinical responses were evaluated and compared by using monthly photographic records .

Official Title
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Superior Efficacy of Azithromycin and Levamisole Versus of Azithromycin Alone in the Treatment of Inflammatory Acne Vulgaris: An Investigator Blind Randomized Clinical Trial on 169 Patients

Conditions
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Acne

Intervention / Treatment
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* Drug: Levamisole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had at least 20 papules and/or pustules, Patients with nodule and/or cyst disregarding the number of papules of pustules, were included the study. There was not any age limit Exclusion Criteria: were using any type of systemic treatment for their acne at the time of visit or during the last month; had any hematological, renal or hepatic disease were pregnant or lactating; had drug-induced acne; were using alcohol, anti-convulsants or anti-coagulants.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromicine plus levamisole<br> | Drug: Levamisole<br>* Group 1: Azithromycin 500 mg per day, three days a week plus oral levamisole 150 mg per day, two days a week. Group 2: Azithromycin 500 mg per day, three days a week. The used medications were not revealed to their physician. A questionnaire was filled for every patient and photos were taken from lesions using a digital camera at first, second and final visit.<br>|
| Experimental: Azithromicin<br> | Drug: Levamisole<br>* Group 1: Azithromycin 500 mg per day, three days a week plus oral levamisole 150 mg per day, two days a week. Group 2: Azithromycin 500 mg per day, three days a week. The used medications were not revealed to their physician. A questionnaire was filled for every patient and photos were taken from lesions using a digital camera at first, second and final visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | A questionnaire was filled for every patient.For patients in both groups, lab tests were done at each visit.All adverse effect and the number of them were recorded and the patients who had side-effects or didn't follow the visits were excluded from the study. | one year |