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

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

This study is currently recruiting participants.
Verified by Shaheed Beheshti Medical University, January 2008

Sponsored by:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00419848

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 II

MedlinePlus related topics:

Acne

ChemIDplus related topics:

Azithromycin Doxycycline Doxycycline calcium Doxycycline hyclate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Shaheed 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
1: Experimental	Drug: Azithromycin Azithromycin: Cap 250 mg- 500 mg single dose/daily - 3 times per week
2: Active Comparator	Drug: Doxycycline Cap 100mg- 100mg/daily

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

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

Shaheed 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

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

Keywords provided by Shaheed Beheshti Medical University:

Acne

Azithromycin

Doxycycline

Study placed in the following topic categories:

Exanthema

Facial Dermatoses

Facies

Skin Diseases

Azithromycin

Sebaceous Gland Diseases

Doxycycline

Acne Vulgaris

Additional relevant MeSH terms:

Antimalarials

Anti-Infective Agents

Anti-Bacterial Agents

Antiparasitic Agents

Antiprotozoal Agents

Acneiform Eruptions

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008