E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acne vulgaris |
Akné vulgaris |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000496 |
E.1.2 | Term | Acne |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 the study is to investigate the efficacy and the safety of NAI-Acne 3% gel in patients with moderate to severe facial acne applying the investigational product for 12 weeks in comparison with placebo. Efficacy of the NAI-Acne gel will be evaluated in terms of absolute and percent change in inflammatory lesion count (ILC), score reduction after investigator’s global assessment (IGA), absolute and percent change in total lesion count (TLC) and change in Cardiff acne disability index (CADI). |
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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 |
1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: men aged 18-50 years old inclusive 3. Diagnosis: moderate to severe facial acne with an IGA of 3-4 at screening and at baseline 4. Cutaneous lesions: 15≤inflammatory lesions≤70 located at or above the jawline 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study 6. Contraception: willingness to use a barrier form of contraceptive with spermicidal foam/gel/film/cream/suppository throughout the study.
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E.4 | Principal exclusion criteria |
1. Face skin conditions: face skin lesions other than acne lesions or local conditions preventing a correct evaluation of acne lesions (e.g. beard) 2. Nodulocystic acne: significant nodulocystic acne on the face i.e. ≥4 facial nodules defined as inflammatory lesions ≥0.5 cm in diameter and/or ≥1 facial cystic lesions defined as larger nodules undergoing suppuration 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness; presence of abnormalities including alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyl transferase (γ-GT), creatinine, urea and/or glucose values above 2x upper limit of normality (ULN) of the laboratory performing the analysis 4. Allergy: ascertained or presumptive hypersensitivity to antibiotics and/or to the test formulations' ingredients 5. Diseases: underlying severe renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin (excluding facial acne vulgaris), haematological, endocrine or neurological diseases including severe infections and viral diseases that may interfere with the aim of the study 6. Medications: systemic antibiotics, acne medications and/or light therapies in the month preceding the screening; topical antibiotics, antiseptics and/or acne medications in 2 weeks preceding the screening; continuous concurrent use of topical and/or systemic medications acting on or influencing acne 7. Investigative drug studies: participation in the evaluation of any investigational product within 30 days of the screening 8. Exposure to sun: inability and/or unwillingness to avoid excessive natural or artifical exposure to UV rays during the whole study duration
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Absolute and percent change in ILC from baseline to week 12 compared between treatments |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Absolute and percent change in ILC from baseline to weeks 4 and 8 compared between treatments; 2. Absolute and percent change in TLC from baseline to weeks 4, 8 and 12 compared between treatments; 3. Proportion of subjects with an IGA score reduction of at least 2 (defined as a success) from baseline to week 12 compared between treatments; 4. Change in CADI from baseline to week 12 compared between treatments; 5. Evaluation of safety, tolerability and local tolerability of the test treatment as compared to the matching placebo.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. From baseline to weeks 4 and 8. 2. From baseline to weeks 4, 8 and 12. 3. From baseline to week 12. 4. From baseline to week 12. 5. During the whole duration of the study. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 6 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |