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the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris
This study is currently recruiting participants.
Verified by Shaheed Beheshti Medical University, January 2008
First Received: January 8, 2007   Last Updated: January 28, 2008   History of Changes
Sponsor: Shaheed Beheshti Medical University
Information provided by: Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT00419848
  Purpose

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


Condition Intervention Phase
Acne
Drug: Doxycycline
Drug: Azithromycin
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • change in acne lesions [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • global response rates, patient's own assessment, side effects and compliance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2006
Estimated Study Completion Date: February 2008
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Azithromycin
Azithromycin: Cap 250 mg- 500 mg single dose/daily - 3 times per week
2: Active Comparator Drug: Doxycycline
Cap 100mg- 100mg/daily

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419848

Contacts
Contact: Parviz Toossi, M.D. 98-21-22744393 ext 5 src@sbmu.ac.ir

Locations
Iran, Islamic Republic of
Shaheed Beheshti Medical University, Skin research center Recruiting
Tehran, Iran, Islamic Republic of, 198994148
Sponsors and Collaborators
Shaheed Beheshti Medical University
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
  More Information

No publications provided

Responsible Party: Shaheed Beheshti Medical unversity ( Skin research center )
Study ID Numbers: src-hmj-1385
Study First Received: January 8, 2007
Last Updated: January 28, 2008
ClinicalTrials.gov Identifier: NCT00419848     History of Changes
Health Authority: Iran: Ministry of Health

Keywords provided by Shaheed Beheshti Medical University:
Acne
Azithromycin
Doxycycline

Additional relevant MeSH terms:
Anti-Infective Agents
Antiprotozoal Agents
Facial Dermatoses
Skin Diseases
Sebaceous Gland Diseases
Acne Vulgaris
Pharmacologic Actions
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Acneiform Eruptions
Azithromycin
Therapeutic Uses
Doxycycline

ClinicalTrials.gov processed this record on November 27, 2009