Acne Vulgaris MedDRA version: 20.0 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000018399
Conditions
Interventions
Trade Name: Duac
Product Name: Duac
Product Code: Duac
Pharmaceutical Form: Gel
INN or Proposed INN: CLINDAMYCIN
Other descriptive name: CLINDAMYCIN
Concentration unit: % percent
Concentration type: e
Sponsors
GlaxoSmithKline GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are males or females 12 to 45 years of age, inclusive. 2. Subjects with acne vulgaris who have: - a minimum of 17 to a maximum of 60 inflammatory facial lesions (papules and pustules), including the nose, and no more than 1 facial nodular cystic lesions. - and a minimum of 20 to a maximum of 125 non-inflammatory facial lesions (open and closed comedones). - and an ISGA score of 2 or 3. 3. Subjects agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks prior to entering the study and to minimize the amount of exposure to direct sunlight for the duration of the study. 4. Subjects who are capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed. Subjects under the legal age of consent must provide assent and have the written, informed consent of both parents or legal guardians. Are the trial subjects under 18? yes Number of subjects for this age range: 104 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 113 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Unable to comply with the requirement of the study. 2. Female patients who are pregnant, breast-feeding, or sexually active and not using 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, 3, 4 and 5, for all females if menarche has occurred). 3. Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris. 4. Subjects who have facial hair that may obscure the accurate assessment of acne grade. 5. Subjects who have a history or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms. 6. Prior Therapy: Have received treatment with the following therapies at the times specified prior to Baseline: Systemic retinoids 6 months systemic anitbiotics, investigational therapy, facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet (UV) therapy, topical corticosteroids on the face or systemic corticosteroids - 4 weeks Topical anitibiotics on the face, topical anti-acne medications (eg BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid - 2 weeks Medications that are reported to exacerbate acne (eg. mega-doses of certain vitamins such as vitamin D, vitamin A an dvitamins B2, B6 and B12; haloperidol, halogens such as iodide and bromide; lithium, hydantoin; and phenobarbital) as these may impact efficacy assessments - 1 day neuromuscular blocking agents (clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents) - 1 day drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity - 1 day 7. Subjects who are unwilling to stop using the following types of facial products during the study: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, nonmild facial cleansers, or moisturizers that contain retinol, salicylic acid, or a- or ß- hydroxy acids. 8. Subjects who have a known hypersensitivity or previous allergic reaction to any of the active components (azaleic acid, lincomycin, clindamycin, BPO), or excipients of the study medication. 9. Use of estrogens, including oral, implanted, and topical contraceptives, androgens, or anti-androgenic agents of less than 12 consecutive weeks prior to start of study dosing (change of the dose or drug is not permitted between 12 weeks prior study dosing until end of the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy, safety and tolerability of Duac vs Skinoren.;Secondary Objective: Not applicable;Primary end point(s): % change from baseline of inflammatory lesion count at week 4 – superiority analysis;Timepoint(s) of evaluation of this end point: Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Lesion count (IL, NIL, Total) 0,2,4,8,12 wks ISGA 0,2,4,8,12 wks Speed of onset : time to 50% reduction in total lesion count Investigator tolerability 0,2,4,8,12 wks SGCA 2,4,8,12 wks Subject tolerability 0,2,4,8,12 wks Patient satisfaction score at week 12 (simple grading) Adherence at week 12 Quality of Life Assessments: DLQI (17-45 years of age) or CDLQI (12-16 years of age) 0,2,4,8,12 wks Number of treatment related AEs and SAEs;Timepoint(s) of evaluation of this end point: 0,2,4,8,12 weeks | — |
Countries
Germany
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed