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NCT00419848 Clinical Trial

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

Acne Clinical Trial

Official title:
the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00419848
Other study ID # src-hmj-1385
Secondary ID
Status Recruiting
Phase Phase 2
First received January 8, 2007
Last updated January 28, 2008
Start date August 2006
Est. completion date February 2008

Study information
Verified date January 2008
Source hahid Beheshti University of Medical Sciences
Contact Parviz Toossi, M.D.
Phone 98-21-22744393
Email src@sbmu.ac.ir
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date February 2008
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Iran, Islamic Republic of Shaheed Beheshti Medical University, Skin research center Tehran

Sponsors (1)
Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in acne lesions 12 weeks Yes
Secondary global response rates, patient's own assessment, side effects and compliance 12 weeks Yes
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