Back to resultsthe Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris
Primary Purpose
Acne
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Doxycycline
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Acne focused on measuring Acne, Azithromycin, Doxycycline
Eligibility 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
Sites / Locations
- Shaheed Beheshti Medical University, Skin research centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
change in acne lesions
Secondary Outcome Measures
global response rates, patient's own assessment, side effects and compliance
Full Information
NCT ID
NCT00419848
First Posted
January 8, 2007
Last Updated
January 28, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00419848
Brief Title
the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris
Official Title
the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
January 2008 (Anticipated)
Study Completion Date
February 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin in the management of moderate acne vulgaris
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
Acne, Azithromycin, Doxycycline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Razak lab
Intervention Description
Cap 100mg- 100mg/daily
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
kimidarou
Intervention Description
Azithromycin: Cap 250 mg- 500 mg single dose/daily - 3 times per week
Primary Outcome Measure Information:
Title
change in acne lesions
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
global response rates, patient's own assessment, side effects and compliance
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Parviz Toossi, M.D.
Phone
98-21-22744393
Ext
5
Email
src@sbmu.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parviz Toossi, M.D.
Organizational Affiliation
Skin Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hamideh Moravvej, M.D.
Organizational Affiliation
Skin Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Akbar Mousazadeh halim, M.D.
Organizational Affiliation
Skin Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaheed Beheshti Medical University, Skin research center
City
Tehran
ZIP/Postal Code
198994148
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris
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