Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea - Full Text View

Sponsor:	Intendis GmbH
Information provided by:	Intendis GmbH
ClinicalTrials.gov Identifier:	NCT00855595

Purpose

Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg)daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.

Condition	Intervention	Phase
Papulopustular Rosacea	Drug: azelaic acid gel plus 40 mg doxycycline Drug: metronidazole plus doxycycline	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily in Subjects With Moderate Papulopustular Rosacea

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Doxycycline Doxycycline hyclate Metronidazole hydrochloride Metronidazole phosphate Doxycycline calcium Azelaic acid Metronidazole

U.S. FDA Resources

Further study details as provided by Intendis GmbH:

Primary Outcome Measures:

Change in inflammatory lesion count from baseline [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rapidity of improvement [ Time Frame: From baseline to end of treatement ] [ Designated as safety issue: No ]

Enrollment:	200
Study Start Date:	February 2009
Study Completion Date:	October 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: azelaic acid topically	Drug: azelaic acid gel plus 40 mg doxycycline azelaic acid gel 15% topically twice daily for 12 weeks and doxycycline 40 mg once daily for 12 weeks Other Name: Finacea
Active Comparator: metronidazole Metrogel	Drug: metronidazole plus doxycycline topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks Other Name: Metrogel

Detailed Description:

The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

moderate papulopustular rosacea (IGA>4) with a minimum of 10 and no more than 50 inflammatory lesions and persistent erythema with or without telangiectasia

Exclusion Criteria:

sensitivity to any of the treatments used
co-existing conditions that would unfavorably influence the course of the disease
pregnant or lactating women
severe rosacea

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855595

Locations

United States, Nevada
James Del Rosso, MD
Henderson, Nevada, United States, 89052

Sponsors and Collaborators

Intendis GmbH

Investigators

Principal Investigator:

James Del Rosso, MD

Private Practice in Henderson Nevada

More Information

No publications provided

Responsible Party:	Dr Allan Kayne, Intendis Inc.
ClinicalTrials.gov Identifier:	NCT00855595 History of Changes
Other Study ID Numbers:	1402604, Project number: 256-0024
Study First Received:	March 3, 2009
Last Updated:	June 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Intendis GmbH:

rosacea

Additional relevant MeSH terms:

Rosacea
Skin Diseases
Anti-Inflammatory Agents
Doxycycline
Doxycycline hyclate
Metronidazole
Azelaic acid
Therapeutic Uses
Pharmacologic Actions

Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012