E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000496 |
E.1.2 | Term | Acne |
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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 show the non-inferior efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel (quoted below as Adapalene BPO) compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel (Clindamycin BPO), in the treatment acne vulgaris. |
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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. Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris, 2. Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, 3. Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose, 4. Female Subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study: oral contraception (must have been on a stable dose for 3 months prior to study entry), IUD, systemic (injectable or patch) contraception, strict abstinence or partner had a vasectomy, 5. 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, 6. Subjects aged 18 years (16 years in Scotland) or older have to read and sign the approved Informed Consent form prior to any participation in the study. Subjects under the age of 18 (16 in Scotland) may sign an assent form to participate in the study and they must have one parent or guardian (both parents for the German) sites read and sign the Informed Consent form prior to any study related procedure but the parent(s) or guardian is not required to attend the follow-up visits unless requested, 7. Subjects willing and capable of cooperating to the extend and degree required by the protocol. |
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E.4 | Principal exclusion criteria |
1. Subjects with more than three nodulo-cystic lesions, 2. Female Subjects who are pregnant, nursing or planning a pregnancy during the study, 3. Subjects with a condition or who are in a situation which, in the Investigators opinion, may put the Subject at risk (including history of regional enteritis or ulcerative colitis or a history of antibiotic associated colitis), may confound the study results, or may interfere with the Subjects participation in the study, 4. Subjects with known allergy to one of the components of the test products (see package insert and/or investigator brochure), 5. Subjects who have participated in another investigational drug or device research study within 30 days of enrollment, 6. Subjects with a wash-out period for topical treatment on the face less than (see table below): Corticosteroids, antibiotics, antiseptics, retinoids, other anti-inflammatory drugs, or other acne treatments 2 weeks Zinc containing drugs 1 week Phototherapy devices for Acne 1 week 7. Subjects with a wash-out period for systemic treatment less than (see table below): Corticosteroids, antibiotics (except plain penicillins) 4 weeks Other acne treatments (including isotretinoin) 6 months Ciproterone acetate 6 months Spironolactone 3 months NOTE: Oral vitamin A up to the recommended daily dose, 4000-5000 IU, is acceptable 8. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe nodulocystic acne requiring treatment with oral isotretinoin, 9. Subjects with a beard or other facial hair that might interfere with study assessments, 10. Subjects who are at risk in terms of precautions, warnings, and contra-indication (see package insert and/or investigator brochure), 11. 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) |
The purpose of this study is to show the non-inferior efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel (quoted below as Adapalene BPO) compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel (Clindamycin BPO), in the treatment acne vulgaris. |
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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 | Yes |
E.6.4 | Safety | No |
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) | Yes |
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 | 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
| 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 | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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- Mancanza dellefficacia - Eventi avversi - Richiesta del soggetto - Violationi del protocollo - Gravidanza |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |