Treatment of acne vulgaris from mild to moderate severity. MedDRA version: 8.1 Level: LLT Classification code 10000519 Term: Acne vulgaris
Conditions
Interventions
Trade Name: Duac Gel
Pharmaceutical Form: Gel
INN or Proposed INN: clindamycin
Concentration unit: % percent
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: benzoyl peroxide
Co
Sponsors
Laboratorios Stiefel (España), S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects with mild to moderate acne vulgaris of the face with at least 15 inflammatory lesions and/or non-inflammatory lesions, but no more than three nodulocystic lesions and an acne grade of greater than or equal to 2.0 and less than 7.0 (The Leeds Revised Acne Grading System10). 2)Subjects of either sex aged between 12 and 39 years, inclusive. 3)Subjects 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 subjects aged under 16 years of age, parental or guardian consent must be obtained in addition to subject assent. 4)Subjects agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks prior to entering and during the study and to minimise the amount of exposure to direct sunlight for the duration of the study. 5)Subjects agreeing to minimise their alcohol consumption throughout the study, with a limit of 14 units per week. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Female subjects who are pregnant, breast-feeding, or sexually active women of childbearing potential participating in the study not using a medically acceptable form of contraception (which include oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Abstinence is considered as a medically acceptable form of contraception. 2) Subjects using anti-androgen containing contraceptives. 3)Subjects who, during the past month, have received oral or topical steroids, or any kind of oral treatment, including natural or artificial UV therapy, in the last 2 weeks before coming into the study. For oral Isotretionine 6 month wash out period should be fulfilled. 4) Subjects who have a history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the study medications. 5) Subjects using, or having used in the past month, any significant concomitant medication which might affect their acne, as judged by the Investigator. 6) Subjects 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 applies to subjects with psoriasis, acne rosacea, allergic rashes, bacterial, viral or fungal infections of the facial skin, or other diseases of the facial skin. 7) Subjects with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis. 8) Subjects who have a history of photosensitivity. 9) Subjects who are unreliable or unlikely to be available for the duration of the follow-up. 10) Subjects 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) Subjects who are either an immediate family member, or a colleague, of study personnel. 12) Subjects who already have a member of their household entered onto this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the subjects quality of life of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) when applied once daily, with a gel containing 0.1% adapalene applied also once daily for the treatment of acne vulgaris from mild to moderate severity. ;Secondary Objective: To compare the efficacy and the tolerance of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) when applied once daily, with a gel containing 0.1% adapalene applied also once daily for the treatment of acne vulgaris from mild to moderate severity. ;Primary end point(s): Change from baseline of the quality of life score of the subjects at week 2. | — |
Countries
Portugal
Outcome results
None listed