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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00419848
First received: January 8, 2007
Last updated: January 28, 2008
Last verified: January 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Shahid 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
Experimental: 1 Drug: Azithromycin
Azithromycin: Cap 250 mg- 500 mg single dose/daily - 3 times per week
Other Name: kimidarou
Active Comparator: 2 Drug: Doxycycline
Cap 100mg- 100mg/daily
Other Name: Razak lab

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Shahid Beheshti Medical University:
Acne
Azithromycin
Doxycycline

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

ClinicalTrials.gov processed this record on November 25, 2014