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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Papulopustular Rosacea

Intervention: azelaic acid 15% gel (Drug); azelaic acid 15% gel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Investigator's global assessment scored on a seven point scale

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Intendis GmbH, Berlin, Germany
Additional Information

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Starting date: January 2007
Last updated: February 20, 2014

Page last updated: August 20, 2015

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