E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with mild to moderate perioral dermatitis of the facial area and meeting the specific eligibility criteria |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012484 |
E.1.2 | Term | Dermatitis perioral |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as last visit of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |