Skip to content

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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01348321
Enrollment
169
Registered
2011-05-05
Start date
2008-11-30
Completion date
2009-10-31
Last updated
2011-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne

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 .

Interventions

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.

Sponsors

Ahvaz Jundishapur University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Adverse Eventsone yearA 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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026