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

a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin in the management of moderate acne...

Date First Received: January 8, 2007

Last Updated: January 28, 2008

Verified by: Shaheed Beheshti Medical University, January 2008

Clinical Trial Phase: Phase 2 | Start Date: August 2006

Overall Status: Recruiting

Estimated Enrollment: 100

Brief Summary

Official Title: “the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris”

Condition Keyword(s):

a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin in the management of moderate acne vulgaris

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

  • Drug: Doxycycline
    • Cap 100mg- 100mg/daily
  • Drug: Azithromycin
    • Azithromycin: Cap 250 mg- 500 mg single dose/daily - 3 times per week

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • change in acne lesions
    • Time Frame: 12 weeks
      Safety Issue?: Yes

Secondary Measures

  • global response rates, patient's own assessment, side effects and compliance
    • Time Frame: 12 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 30 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Sponsor Information

Lead Sponsor: Shaheed Beheshti Medical University

Overall Clinical Trial Officials and Contacts

Parviz Toossi, M.D. Study Chair Skin Research Center  

Overall Contact: Parviz Toossi, M.D. 98-21-22744393 src@sbmu.ac.ir

Additional Information

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00419848

Study ID Number: src-hmj-1385

ClinicalTrials.gov Identifier: NCT00419848

Health Authority: Iran: Ministry of Health

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