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

NCT01348321 | Completed Phase 2 DMC

• 2 other identifiers: Acne and levamisole126/د
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Azithromicine plus levamisole

EXPERIMENTAL

Drug: Levamisole

Azithromicin

EXPERIMENTAL

Drug: Levamisole

Interventions

Levamisole DRUG

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.

Azithromicin; Azithromicine plus levamisole

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahvaz Jundishapur University of Medical Sciences: lead

Study Sites (1)

Azadegan Street,Imam Hospital,Department of Dermatology

Ahvāz, Khoozestan, 6193673166, Iran

Location

Related Publications (3)

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

  PMID: 6457452 BACKGROUND

• 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.

  PMID: 18720689 RESULT

• Rassai S, Mehri M, Yaghoobi R, Sina N, Mohebbipour A, Feily A. Superior efficacy of azithromycin and levamisole vs. azithromycin in the treatment of inflammatory acne vulgaris: an investigator blind randomized clinical trial on 169 patients. Int J Clin Pharmacol Ther. 2013 Jun;51(6):490-4. doi: 10.5414/CP201861.

  PMID: 23547851 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Levamisole

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sima Rasaii, Dermtologist

  Jundishapur University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: May 5, 2011
• Study Start: November 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 5, 2011

Record last verified: 2008-10

Locations

IR (1)