Acne Vulgaris
Conditions
Interventions
Trade Name: DUAC Gel
Pharmaceutical Form: Gel
INN or Proposed INN: BENZOYL PEROXIDE
Other descriptive name: BENZOYL PEROXIDE
Concentration unit: % percent
Concentration type: equal
Concentration numbe
Sponsors
GlaxoSmithKline Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects must be males or females 12 to 45 years of age. - Subjects must have acne on their face. - Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit. - Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. - Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements). - Subjects must be able to complete the study and to comply with study instructions. Are the trial subjects under 18? yes Number of subjects for this age range: 301 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 286 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects who are pregnant, trying to become pregnant, or breast-feeding. - Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination - History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products - Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months. - Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study. - Other exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris. ;Secondary Objective: Not applicable;Primary end point(s): The absolute change in lesion counts (total, inflammatory, noninflammatory) from baseline to week 12. The proportion of subjects who have a minimum 2-grade improvement in ISGA score from baseline to week 12.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The percent (%) change in lesion counts (total, inflammatory, noninflammatory) from baseline to week 12. The proportion of subjects who have an ISGA score of 0 or 1 at week 12.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development
Outcome results
None listed