Status:

COMPLETED

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

Lead Sponsor:

LEO Pharma

Collaborating Sponsors:

Bayer

Conditions:

Papulopustular Rosacea

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2007

Estimated Enrollment :

98 Patients enrolled

Trial Details

Trial ID

NCT00417937

Start Date

January 1 2007

End Date

June 1 2007

Last Update

June 9 2023

Active Locations (1)

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1

Intendis GmbH

Berlin, Germany