A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis
This study has been completed.
Sponsor:
Intendis GmbH
Information provided by:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT00403949
First received: November 23, 2006
Last updated: December 3, 2007
Last verified: June 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Perioral Dermatitis |
Drug: Azelaic Acid 15% Gel Drug: Azelaic acid 15% gel Drug: Non-active base from azelaic acid 15% gel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Intendis GmbH:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 48 |
| Study Start Date: | November 2006 |
| Study Completion Date: | March 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Azelaic acid 15% Gel
Azelaic acid 15%
|
Drug: Azelaic Acid 15% Gel
topical gel, apply once daily for six weeks
Drug: Azelaic acid 15% gel
gel, applied once daily, for 6 weeks
|
|
Placebo Comparator: 2
Non-active base from Azelaic acid 15% gel
|
Drug: Non-active base from azelaic acid 15% gel
gel, apply once daily for six weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Klaus Graupe, Intendis GmbH |
| ClinicalTrials.gov Identifier: | NCT00403949 History of Changes |
| Other Study ID Numbers: | 1400418, 2006-002471-40 |
| Study First Received: | November 23, 2006 |
| Last Updated: | December 3, 2007 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Perioral Skin Diseases Facial Dermatoses Azelaic acid |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013