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

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ClinicalTrials.gov Identifier: NCT00419848
Recruitment Status : Unknown
Verified January 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 9, 2007
Last Update Posted : January 29, 2008
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Study Description
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Brief Summary:
a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin in the management of moderate acne vulgaris

Condition or disease Intervention/treatment Phase
Acne Drug: Doxycycline Drug: Azithromycin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris
Study Start Date : August 2006
Estimated Primary Completion Date : January 2008
Estimated Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. change in acne lesions [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. global response rates, patient's own assessment, side effects and compliance [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419848


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

Locations
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Iran, Islamic Republic of
Shaheed Beheshti Medical University, Skin research center Recruiting
Tehran, Iran, Islamic Republic of, 198994148
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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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
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Responsible Party: Skin research center, Shaheed Beheshti Medical unversity
ClinicalTrials.gov Identifier: NCT00419848    
Other Study ID Numbers: src-hmj-1385
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: January 29, 2008
Last Verified: January 2008
Keywords provided by Shahid Beheshti University of Medical Sciences:
Acne
Azithromycin
Doxycycline
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Azithromycin
Doxycycline
 Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents