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

LEO Pharma98 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Papulopustular Rosacea

Interventions

azelaic acid 15% gelDRUG

15% gel, topically applied once daily for six weeks

azelaic acid 15% gelDRUG

15% gel, topically applied twice daily for six weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Intendis GmbH

Berlin, Germany

Outcomes

Primary Outcomes

Investigator's global assessment scored on a seven point scale

Time frame: Measurements made during the course of treatment

Secondary Outcomes

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

Time frame: Parameters measured during the course of treatment

Data from ClinicalTrials.gov

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