| November 23, 2006 |
| December 3, 2007 |
| November 2006 |
| |
| The sum score derived from the most important signs and symptoms of perioral dermatitis [ Time Frame: Measurements and observations during the course of the study ] [ Designated as safety issue: No ] |
| The sum score derived from the most important signs and symptoms of perioral dermatitis |
| Complete list of historical versions of study NCT00403949 on ClinicalTrials.gov Archive Site |
- Intensity of single signs and symptoms [ Time Frame: Measured at scheduled visits during the course of the study ] [ Designated as safety issue: No ]
- Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator [ Time Frame: Safety parameters recorded at scheduled visits during the course of the study ] [ Designated as safety issue: Yes ]
|
- Intensity of single signs and symptoms
- Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator
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| |
| A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis |
| A 6-Week, Vehicle-Controlled, Randomized, Double-Blind, Parallel-Group Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Perioral Dermatitis |
The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Perioral Dermatitis |
- Drug: Azelaic Acid 15% Gel
- Drug: Azelaic acid 15% gel
- Drug: Non-active base from azelaic acid 15% gel
|
- Active Comparator: Azelaic acid 15%
- Placebo Comparator: Non-active base from Azelaic acid 15% gel
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| |
| |
| Completed |
| 48 |
| March 2007 |
|
Inclusion Criteria:
- Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by the physician
- 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:
- 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 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
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Germany |
| |
| NCT00403949 |
| Klaus Graupe, Intendis GmbH |
| 1400418, 2006-002471-40 |
| Intendis GmbH |
|
| Study Director: |
Intendis GmbH |
+49 30 5200 75 802 |
|
|
| Intendis GmbH |
| June 2007 |
