A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily - Tabular View

Tracking Information

First Received Date ^ICMJE

January 2, 2007

Last Updated Date

December 3, 2007

Start Date ^ICMJE

January 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Investigator's global assessment scored on a seven point scale [ Time Frame: Measurements made during the course of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Investigator's global assessment scored on a seven point scale

Change History

Complete list of historical versions of study NCT00417937 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy [ Time Frame: Parameters measured during the course of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy

Descriptive Information

Brief Title ^ICMJE

A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily

Official Title ^ICMJE

A Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice Daily in Subjects With Papulopustular Rosacea

Brief Summary

To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.

Detailed Description

To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Papulopustular Rosacea

Intervention ^ICMJE

Drug: azelaic acid 15% gel

Study Arms / Comparison Groups

Active Comparator: Azelaic acid 15 % gel once daily
Active Comparator: Azelaic acid 15 gel twice daily

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

Completed

Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules

Exclusion Criteria:

Mild or severe rosacea
Rosacea with marked ocular manifestations
Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course
Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia
History of hypersensitivity to propylene glycol

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00417937

Responsible Party

Klaus Graupe/Senior Medical Advisor, Intendis GmbH

Study ID Numbers ^ICMJE

1401460

Study Sponsor ^ICMJE

Intendis GmbH

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Intendis GmbH

Information Provided By

Intendis GmbH

Verification Date

December 2007

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