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

Primary Purpose

Papulopustular Rosacea

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

azelaic acid 15% gel

About this trial

This is an interventional treatment trial for Papulopustular Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Intendis GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Azelaic acid 15 % gel once daily

Azelaic acid 15 gel twice daily

Outcomes

Primary Outcome Measures

Investigator's global assessment scored on a seven point scale

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00417937

First Posted

January 2, 2007

Last Updated

June 8, 2023

Sponsor

LEO Pharma

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00417937

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Papulopustular Rosacea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Azelaic acid 15 % gel once daily

Arm Title

Arm Type

Active Comparator

Arm Description

Azelaic acid 15 gel twice daily

Intervention Type

Drug

Intervention Name(s)

azelaic acid 15% gel

Intervention Description

15% gel, topically applied once daily for six weeks

Intervention Type

Drug

Intervention Name(s)

azelaic acid 15% gel

Intervention Description

15% gel, topically applied twice daily for six weeks

Primary Outcome Measure Information:

Title

Investigator's global assessment scored on a seven point scale

Time Frame

Measurements made during the course of treatment

Secondary Outcome Measure Information:

Title

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

Time Frame

Parameters measured during the course of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

Facility Name

Intendis GmbH

City

Berlin

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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