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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348321
• Other study ID #: Acne and levamisole
• Secondary ID: 126/?
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 25, 2011
• Last updated: May 4, 2011
• Start date: November 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2008
• Source: Ahvaz Jundishapur University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• Levamisole
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Azadegan Street,Imam Hospital,Department of Dermatology	Ahvaz	Khoozestan

Sponsors (1)

Lead Sponsor	Collaborator
Ahvaz Jundishapur University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

Ansarin H, Savabynasab S, Behzadi AH, Sadigh N, Hasanloo J. Doxycycline plus levamisole: combination treatment for severe nodulocystic acne. J Drugs Dermatol. 2008 Aug;7(8):737-40. — View Citation

Haneke E. [Levamisole treatment of acne fulminans (author's transl)]. Z Hautkr. 1981 Sep 1;56(17):1160-6. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes