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

Phase 2

Completed

• Conditions: Acne
• Interventions: Drug: Levamisole

• Registration Number: NCT01348321
• Lead Sponsor: Ahvaz Jundishapur University of Medical Sciences

Brief Summary

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

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 .

Study Timeline

• Status Verified: 2008-10
• Study Start: 2008-11
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-05-04
• Last Update Submitted: 2011-05-04
• Study First Posted: 2011-05-05
• Last Update Posted: 2011-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

1. Patients who had at least 20 papules and/or pustules,
2. 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

1. were using any type of systemic treatment for their acne at the time of visit or during the last month;
2. had any hematological, renal or hepatic disease
3. were pregnant or lactating;
4. had drug-induced acne;
5. were using alcohol, anti-convulsants or anti-coagulants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithromicine plus levamisole	Levamisole	-
Azithromicin	Levamisole	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	one year	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.

Trial Locations

Locations (1)

Azadegan Street,Imam Hospital,Department of Dermatology; 🇮🇷 Ahvaz, Khoozestan, Iran, Islamic Republic of