the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris - Tabular View

Tracking Information

First Received Date ^ICMJE

January 8, 2007

Last Updated Date

January 28, 2008

Start Date ^ICMJE

August 2006

Estimated Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00419848 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acne

Intervention ^ICMJE

Drug: Doxycycline
Drug: Azithromycin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

February 2008

Estimated Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 30 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Parviz Toossi, M.D.

98-21-22744393 ext 5

src@sbmu.ac.ir

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT ID ^ICMJE

NCT00419848

Responsible Party

Skin research center, Shaheed Beheshti Medical unversity

Study ID Numbers ^ICMJE

src-hmj-1385

Study Sponsor ^ICMJE

Shaheed Beheshti Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Shaheed Beheshti Medical University

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP