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

This study has been completed.
Sponsor:
Information provided by:
Ahvaz Jundishapur University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01348321
First received: April 25, 2011
Last updated: May 4, 2011
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Acne
Drug: Levamisole
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Ahvaz Jundishapur University of Medical Sciences:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 169
Study Start Date: November 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azithromicine plus levamisole 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.
Experimental: Azithromicin 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.

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 .

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01348321

Locations
Iran, Islamic Republic of
Azadegan Street,Imam Hospital,Department of Dermatology
Ahvaz, Khoozestan, Iran, Islamic Republic of, 6193673166
Sponsors and Collaborators
Ahvaz Jundishapur University of Medical Sciences
Investigators
Principal Investigator: Sima Rasaii, Dermtologist Jundishapur University of Medical Sciences
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sima Rasaii, Jundishapur University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01348321     History of Changes
Other Study ID Numbers: Acne and levamisole, 126/د
Study First Received: April 25, 2011
Last Updated: May 4, 2011
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Levamisole
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 29, 2014