E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe acne vulgaris of the face |
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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 | 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 demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris. The safety of the two treatment regimens will also be evaluated |
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E.2.2 | Secondary objectives of the trial |
The safety of the two treatment regimens will also be evaluated |
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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, 2.Subjects with moderate to severe facial acne vulgaris (Investigators Global Assessment score of 3 or 4), 3.Subjects with a minimum of 20 Inflammatory Lesions (papules and pustules) on the face, excluding the nose, 4.Subjects with a minimum of 30 and a maximum of 120 Non-Inflammatory Lesions (open comedones and closed comedones) on the face, excluding the nose, 5.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/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, 6.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, 7.Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study. Subjects under the majority must sign an assent-to-participate form to participate in the study and they must have one parent or guardian read and sign the Informed Consent form prior to any study related procedure, 8.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 3 nodules or cysts 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 drugs or other acne treatments 2 weeks Zinc containing drugs 1 week Phototherapy devices for acne and cosmetic procedures: 1 week 5.Subjects with a wash-out period for systemic treatment less than (see table below): Acne therapy containing zinc 4 weeks Corticosteroids, antibiotics 4 weeks Other acne treatments (including isotretinoin and hormonal contraceptives solely for control of acne) 6 months Ciproterone acetate / Chlormadinone acetate 6 months Spironolactone / Drospirenone 3 months 6.Subjects with known impaired hepatic or renal functions. 7.Subjects with known intolerance to lactose. 8.Subjects with a condition or who are in a situation which, in the Investigators opinion, may put the Subject at risk (e.g. history of significant renal disease with impairment of renal function), may confound the study results, or may interfere with the Subjects participation in the study, 9.Subjects who are at risk in terms of precautions, warnings, and contraindications (see package insert and/or Investigator brochure), 10.Subjects with known or suspected allergy to one of the investigational products (see package insert and/or investigator brochure), 11.Subjects who have participated in another investigational drug or device research study within 30 days of enrollment, 12.Subjects with a beard or other facial hair that might interfere with study assessments, 13.Adult Subjects under guardianship, hospitalised Subjects in a public or private institution for a reason other than the Research, and Subjects deprived of their freedom. 14.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 primary objective of this study will be to demonstrate a superiority of Adapalene-BPO Gel associated with Lymecycline compared to its Vehicle Gel associated with Lymecycline, in terms of percent change in Total Lesion counts at Week 12 (LOCF). |
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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 | 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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
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
| |
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 | 6 |
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 | 6 |