Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-06-30

Brief Summary

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This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.

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Detailed Description

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Conditions

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Papulopustular Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Azelaic acid foam, 15% (BAY39-6251)

Participants received azelaic acid foam, 15% topically twice daily for 12 weeks

Group Type EXPERIMENTAL

Azelaic acid

Intervention Type DRUG

15% foam to be applied topically twice daily

Vehicle foam

Participants received vehicle foam topically twice daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Vehicle foam

Intervention Type DRUG

Active-ingredient-free vehicle to be applied topically twice daily

Interventions

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Azelaic acid

15% foam to be applied topically twice daily

Intervention Type DRUG

Vehicle foam

Active-ingredient-free vehicle to be applied topically twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male and female patient at least 18 years of age
* signed informed consent
* Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia
* Ability and willingness to accept and comply with treatment and required medical examinations

Exclusion Criteria

* Known non-responders to azelaic acid
* Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
* Presence of dermatoses that could interfere with the rosacea diagnosis
* Treatment with isotretinoin in the six months prior to randomization
* Treatment of the face with topical retinoids during the two weeks prior to randomization
* Treatment with oral antibiotics during the four weeks prior to randomization
* Treatment with topical antibiotics
* Treatment with systemic corticosteroids during 4 weeks prior to randomization
* Treatment of the face with topical corticosteroids during 2 weeks prior to randomization
* Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization
* Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization
* Use of a sauna during 2 weeks prior to randomization and during the study
* Facial laser surgery for telangiectasia during 6 weeks prior to randomization
* Planned concurrent use of any treatment other than study medication that affects rosacea
* History of hypersensitivity to propylene glycol or any other ingredient of the study drugs
* Participation in another clinical trial during the last 4 weeks

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No