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

Primary Purpose

Acne

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Levamisole
Sponsored by
Ahvaz Jundishapur University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Azadegan Street,Imam Hospital,Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Azithromicine plus levamisole

Azithromicin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2011
Last Updated
May 4, 2011
Sponsor
Ahvaz Jundishapur University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01348321
Brief Title
Comparison of Efficacy of Azithromycin and Levamisole Versus of Azithromycin in in the Treatment of Acne
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ahvaz Jundishapur University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azithromicine plus levamisole
Arm Type
Experimental
Arm Title
Azithromicin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Levamisole
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sima Rasaii, Dermtologist
Organizational Affiliation
Jundishapur University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azadegan Street,Imam Hospital,Department of Dermatology
City
Ahvaz
State/Province
Khoozestan
ZIP/Postal Code
6193673166
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
6457452
Citation
Haneke E. [Levamisole treatment of acne fulminans (author's transl)]. Z Hautkr. 1981 Sep 1;56(17):1160-6. German.
Results Reference
background
PubMed Identifier
18720689
Citation
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.
Results Reference
result
PubMed Identifier
23547851
Citation
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.
Results Reference
derived

Learn more about this trial

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

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