E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acne vulgaris with a high level of P. Acnes on the face (obeserved under wood's lamp) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000519 |
E.1.2 | Term | Acne vulgaris |
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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 purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel in order to assess if the retinoid present in Epiduo® (Adapalene) increases the antimicrobial efficacy of Benzoyl Peroxide 2.5% Gel |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female Subjects of any race, aged 18 years or more, 2. Subjects with facial acne, 3. Subjects with high levels of P. acnes counts on the forehead (score of 3 according to a 4-point scale with 0 = no fluorescence and 3 = strong level of fluorescence) under Wood’s lamp, 4. Subjects with a minimum of 10 Inflammatory Lesions (papules and pustules) on the face, excluding the nose, 5. Subjects with a minimum of 10 and a maximum of 100 Non-Inflammatory Lesions (open comedones and closed comedones) on the face, excluding the nose, 6. Female Subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice an effective method of contraception during the study: oral/systemic [injectable, patch…] contraception (must have been on a stable dose for 3 months prior to study entry), Intrauterine Device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy, 7. Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study, 8. Subjects have to read and sign the approved Informed Consent form prior to any participation in the study, 9. Subjects willing and capable of complying with requirements of the protocol visits and procedures.
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E.4 | Principal exclusion criteria |
1. Subjects with more than 1 nodule or cyst on the face, 2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), 3. Female Subjects who are pregnant, nursing or planning a pregnancy during the study, 4. Subjects with a wash-out period for topical treatment on the face less than (see table below): - Corticosteroids, Antibiotics, Antibacterials, Antiseptics, Retinoids, other Anti- Inflammatory treatments or other acne treatments 2 weeks - Phototherapy devices for acne and cosmetic procedures (i.e., facials, peels, comedone extraction) 1 week
5. Subjects with a wash-out period for systemic treatment less than (see table below): • Corticosteroids, Antibiotics 4 weeks • Other acne treatments (including isotretinoin) 6 months • Ciproterone acetate 6 months • Spironolactone 3 months
6. Subjects with a condition or who are in a situation which, in the Investigator’s opinion, may put the Subjects at risk may confound the study results, or may interfere with the Subjects’ participation in the study, 7. Subjects who are at risk in terms of precautions, warnings, and contraindications (see Summary of Medicinal Product Characteristics (SmPC) / Investigational Medicinal Product Dossier (IMPD), 8. Subjects with known or suspected allergy to one of the test products (see Summary of Medicinal Product Characteristics (SmPC) / Investigational Medicinal Product Dossier (IMPD), 9. Subjects who have participated in another investigational drug or device research study within 30 days of enrollment, 10. Adult Subjects under guardianship, hospitalized Subjects in a public or private institution for a reason other than the research, and Subjects deprived of freedom, 11. Subjects with a beard or other facial hair that might interfere with study assessments, 12. Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...).
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from Baseline in P. acnes counts and P. acnes resistant to erythromycin and clindamycin counts at each evaluation time for : - Superficial skin flora (Week 2, Week 6 and Week 12 visits); - Follicular skin flora (Week 12 visit
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |