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 | Classification code | 10000519 |
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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 objectives of this clinical trial are to compare the efficacy and safety of Duac Gel Once Daily (a gel formulation containing a combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), with Differin Gel (a gel containing 0.1% adapalene) once daily, in the treatment of acne vulgaris of mild to moderate severity. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1) Patients with mild to moderate acne vulgaris of the face with at least 15 inflammatory lesions and/or non-inflammatory lesions, but no mre than three nodulocystic lesions and an acne grade of greater than 2 and less than 7.0 (The Leeds Revised Acne Grading System).
2) Patients of either sex aged between 12 and 39 years, inclusive.
3) Patients who are willing and able to provide written informed consent, after being informed of all the pertinent aspects of the trial. In the case of patients aged under 16 years of age, parental or guardian consent must be obtained in addition to patient assent.
4) Patients agreeing not to use sun-beds or undergo any UV light treatment and to minimise the amount of exposure to direct sunlight for the duration of the study.
5) Patients agreeing to minimise their alcohol comsumption throughout the study, with a limit of 14 units per week. |
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E.4 | Principal exclusion criteria |
1) Female patients who are pregnant, breast-feeding, or sexually active and not usinig reliable contraception and/or not prepared to do so for the duration of the trial (a negative pregnancy test must be confirmed at Visit 1, for all females if menarche has occurred).
2) Patients using anti-androgen containing contraceptives.
3) Patients who, during the past month, have received oral or topical steriods, oral or topical antibiotics, or acne treatment of any type, including natural or artifical UV therapy.
4) Patients who have history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the study medications.
5) Patients using, or having used in the past month, any significant concomitant medication which might affect their acne, as judged by the Investigator.
6) Patients with severe systemic diseases (e.g., severely impaired renal or liver function, severe cardiovascular, neurological disease, or any other diseases that may interfere with the evaluation of the study medications). This also applied to patients with psoriasis, acne rosacea, allergic rashes, bacterial, viral or fungal infections of the facial skin, or other diseases of the facial skin.
7) Patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
8) Patients who have a history of photosensitivity.
9) Patients who are unreliable or unlikely to be avilable for the duration of the follow-up.
10) Patients who have participated in a clinical trial involving a drug within 30 days of recruitment into the study (or are likely to do so at any time during their participation).
11) Patients who are either an immediate family member, or a colleague, of study personnel.
12) Patients who already have a member of their household entered onto this trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage change from baseline of inflammatory lesion counts at week 2. |
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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 | Information not present in EudraCT |
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) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | 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 | Information not present in EudraCT |
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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As defined in the protocol under section 6.2, the entire study will end when all patients have completed the study. |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |