Overview

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

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
LEO Pharma
Collaborator:
Bayer
Treatments:
Azelaic acid
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