the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris

January 28, 2008 updated by: Shahid Beheshti University of Medical Sciences
a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin in the management of moderate acne vulgaris

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 198994148
        • Recruiting
        • Shaheed Beheshti Medical University, Skin research center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 18 to 30 year old
  • Moderate facial Acne(At least 10 inflammatory lesions with maximum 3 nodules and pseudocysts

Exclusion Criteria:

  • Pregnancy
  • Breast Feeding
  • Acne Fulminant
  • Acne conglobate
  • Isotretinoin therapy within past 6 months
  • topical treatment in last 2 weeks
  • use of systemic antibiotic in the last month
  • Hyperandrogenism symptoms
  • Menstrual irregularity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Azithromycin
Azithromycin: Cap 250 mg- 500 mg single dose/daily - 3 times per week
Other Names:
  • kimidarou
Active Comparator: 2
Drug: Doxycycline
Cap 100mg- 100mg/daily
Other Names:
  • Razak lab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in acne lesions
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
global response rates, patient's own assessment, side effects and compliance
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Study Chair: Parviz Toossi, M.D., Skin Research Center
  • Principal Investigator: Hamideh Moravvej, M.D., Skin Research Center
  • Principal Investigator: Akbar Mousazadeh halim, M.D., Skin Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Anticipated)

January 1, 2008

Study Completion (Anticipated)

February 1, 2008

Study Registration Dates

First Submitted

January 8, 2007

First Submitted That Met QC Criteria

January 8, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

January 29, 2008

Last Update Submitted That Met QC Criteria

January 28, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • src-hmj-1385

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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