Patients with mild to moderate perioral dermatitis of the facial area and meeting the specific eligibility criteria MedDRA version: 8.1 Level: LLT Classification code 10012484 Term: Dermatitis perioral
Conditions
Sponsors
Intendis GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following inclusion criteria are eligible for this study: 1. Written informed consent (signed and dated) 2. Male or female patients with a minimum age of 18 years 3. Clinical diagnosis of mild to moderate perioral dermatitis 4. Investigator’s Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4) 5. 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles) 6. Willingness and capability to follow all study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria are not eligible for this study and are not to be randomized: 1. History of atopic dermatitis of the face 2. Granulomatous perioral dermatitis 3. Facial acne, rosacea, facial demodicosis 4. Seborrhoic dermatitis of the nasolabial fold, Lupus erythematosus 5. Planned concomitant systemic treatment with antihistamines, analgesic or non-steroidal anti-inflammatory medication 6. Start of hormone use (including for birth control) or change of hormone preparations less than 3 months prior to the start of the study or during the study 7. Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes) 8. Planned treatment during the study period with drugs likely to interfere with the diagnosis and the evaluation of efficacy and safety of the study medication 9. Patients not observing the required duration of washout 10. Pre-treatment with systemic corticosteroids for at least 4 weeks prior to the start of study medication 11. Pre-treatment with oral antibiotics (such as doxycycline, tetracycline, erythromycine and minocycline) for at least 4 weeks prior to the start of study medication 12. Previous systemic treatment with isotretinoin and isoniazid 6 months prior to the start of study medication 13. Previous topical treatment of the face (e.g. antibiotics, calcineurin inhibitors) 2 weeks prior to the start of study medication 14. Use of fluorinated toothpaste 15. Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study 16. Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study 17. History of or suspected hypersensitivity to any ingredient of the study drugs 18. Suspected unreliability, poor co-operation or non-compliance 19. Inability to understand the nature, scope and consequence of the study 20. Participation in another clinical study 4 weeks prior to and/or during the conduct of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this double-blind, randomized, controlled, multicenter, parallel-group phase II pilot-study is to show a superiority of AzA 15% gel SH H 655BA over its vehicle („placebo“; SH H 655PBA) in the 6 weeks treatment of patients with mild to moderate perioral dermatitis. In view of the explorative nature of the study no confirmatory superiority is to be expected. ;Secondary Objective: -;Primary end point(s): The disease status and the course of treatment is primarily evaluated from: - the facial lesion count, i.e. the sum of papules, papulovesicles and papulopustules - score of the intensity of signs and symptoms of perioral dermatitis, i.e. burning, tension, erythema, scaling, dryness, itching These single signs and symptoms are rated on a 5 point score, namely 0 (clear); 1 (minimal); 2 (mild); 3 (moderate); 4 (severe) | — |
Countries
Germany
Outcome results
None listed