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

June 8, 2023 updated by: LEO Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Intendis GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
Drug: azelaic acid 15% gel
15% gel, topically applied twice daily for six weeks
Active Comparator: 2
Azelaic acid 15 gel twice daily
Drug: azelaic acid 15% gel
15% gel, topically applied once daily for six weeks
Drug: azelaic acid 15% gel
15% gel, topically applied twice daily for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigator's global assessment scored on a seven point scale
Time Frame: Measurements made during the course of treatment
Measurements made during the course of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy
Time Frame: Parameters measured during the course of treatment
Parameters measured during the course of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Collaborators

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 2, 2007

First Submitted That Met QC Criteria

January 2, 2007

First Posted (Estimated)

January 4, 2007

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14428
  • 1401460 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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