Last updated: June 8, 2023
Sponsor: LEO Pharma
Overall Status: Completed
Phase
2
Condition
Dermatitis, Atopic
Scalp Disorders
Eczema (Atopic Dermatitis - Pediatric)
Treatment
Azelaic acid 15% gel
Non-active base from azelaic acid 15% gel
Clinical Study ID
NCT00403949
1400418
2006-002471-40
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by thephysician
- Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to
- 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)
Exclusion
Exclusion Criteria:
- History of atopic dermatitis of the face
- 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 treatmentand/or evaluation
- Severe diseases likely to interfere with the conduct / planned termination of thestudy (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 areathroughout the course of the study
- Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fattylipstick) 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 ofthis study
Study Design
Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Azelaic acid 15% gel
Phase: 2
Study Start date:
November 01, 2006
Estimated Completion Date:
March 31, 2007
Connect with a study center
Berlin, 10827
GermanySite Not Available
Dülmen, 48249
GermanySite Not Available
Essen, 45122
GermanySite Not Available
Recklinghausen, 45661
GermanySite Not Available
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