A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis
NCT ID: NCT00403949
Last Updated: 2023-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2006-11-30
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Azelaic acid 15% Gel
Azelaic acid 15%
Azelaic acid 15% gel
gel, applied once daily, for 6 weeks
Placebo
Non-active base from Azelaic acid 15% gel
Non-active base from azelaic acid 15% gel
gel, apply once daily for six weeks
Interventions
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Azelaic acid 15% gel
gel, applied once daily, for 6 weeks
Non-active base from azelaic acid 15% gel
gel, apply once daily for six weeks
Eligibility Criteria
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Inclusion Criteria
* Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4)
* 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)
Exclusion Criteria
* Granulomatous perioral dermatitis
* Facial acne, rosacea, facial demodicosis
* Seborrheic dermatitis of the nasolabial fold, Lupus erythematosus
* The use of topical or systemic medications that could affect the course of treatment and/or evaluation
* Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes)
* Use of fluorinated toothpaste
* Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study
* Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study
* History of or suspected hypersensitivity to any ingredient of the study drugs
* Participation in another clinical study 4 weeks prior to and/or during the conduct of this study
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Berlin, , Germany
Dülmen, , Germany
Essen, , Germany
Recklinghausen, , Germany
Countries
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Other Identifiers
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2006-002471-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1400418
Identifier Type: -
Identifier Source: org_study_id
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