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

Sponsor

LEO Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00417937

Collaborator

Bayer (Industry)

Enrollment

Location

Arms

Duration (Months)

19.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Papulopustular Rosacea	Drug: azelaic acid 15% gel Drug: azelaic acid 15% gel	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Azelaic acid 15 % gel once daily	Drug: azelaic acid 15% gel 15% gel, topically applied once daily for six weeks
Active Comparator: 2 Azelaic acid 15 gel twice daily	Drug: azelaic acid 15% gel 15% gel, topically applied twice daily for six weeks

Arm

Intervention/Treatment

Active Comparator: 1

Azelaic acid 15 % gel once daily

Drug: azelaic acid 15% gel

15% gel, topically applied once daily for six weeks

Active Comparator: 2

Azelaic acid 15 gel twice daily

Drug: azelaic acid 15% gel

15% gel, topically applied twice daily for six weeks

Outcome Measures

Primary Outcome Measures

Investigator's global assessment scored on a seven point scale [Measurements made during the course of treatment]

Secondary Outcome Measures

Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy [Parameters measured during the course of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intendis GmbH	Berlin		Germany

Sponsors and Collaborators

LEO Pharma
Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LEO Pharma

ClinicalTrials.gov Identifier:

NCT00417937

Other Study ID Numbers:

14428
1401460

First Posted:

Jan 4, 2007

Last Update Posted:

Apr 1, 2020

Last Verified:

Feb 1, 2014

Additional relevant MeSH terms:

Rosacea

Azelaic acid

Study Results

No Results Posted as of Apr 1, 2020