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
Pharmaceutical Form: Gel
INN or Proposed INN: CLINDAMYCIN
Other descriptive name: CLINDAMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
GlaxoSmithKline KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects 12 to 45 years (inclusive) of age 2. Subjects must have both: A) A minimum of 17 but not more than 60 inflammatory lesions (papules / pustules) on the face, including nasal lesions. And B) A minimum of 20 but not more than 150 non- inflammatory lesions (open / closed comedones) on the face, including nasal lesions. 3. An Investigator’s Static Global Assessment (ISGA: global assessment of severity by the investigator) score of 2 or greater at Baseline. 4. The ability to understand and give a written informed consent form (Written informed consent must be obtained also from the parent or guardian if the subject is under 20 years of age). 5. Females of childbearing potential and women who are less than 2 years from their last menses must agree to use the following contraception [Hatcher 2007(a); Hatcher 2007(b)]: ? Abstinence; Oral Contraceptive (either combined or progestogen alone), injectable progestogen, implants of levonorgestrel, or estrogenic vaginal ring (as long as the subject has been on treatment for more than 12 consecutive weeks prior to start of investigational product use); ? Intrauterine device (IUD) or intrauterine system (IUS); ? Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject; ? Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository). 6. The ability and willingness to follow all study procedures and to visit all scheduled evaluation points. Male and Female subjects Are the trial subjects under 18? yes Number of subjects for this age range: 130 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 219 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have any nodulo-cystic lesions at Baseline. 2. Are pregnant or breast-feeding. 3. Have a history or presence of regional enteritis, inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, antibiotic-associated colitis or bloody diarrhea) or similar symptoms. 4. Have a medical history suggestive of an immunocompromised status. 5. Used any of the following agents within 2 weeks prior to baseline: ? Topical antibiotics on the face or systemic antibiotics ? Topical anti-acne medications (e.g., BPO, azelaic acid, resorcinol, salicylates etc.) ? Abradants, facials, peels, masks containing glycolic or other acids ? Washes, soaps, non-mild facial cleansers containing BPO, salicylic acid, or sulfacetamide sodium ? Moisturizers that contain retinol, salicylic acid, or a- or ß-hydroxy acids (except additive agent) ? Astringents and toner 6. Used the following agents on the face or performed the following procedure within 4 weeks prior to baseline ? Topical corticosteroids applied onto face (Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable) Facial procedure (such as chemical or laser peel, microdermabration, blue light treatment, etc.) 7. Used systemic retinoids within the previous 6 months or topical retinoids within 6 weeks prior to baseline. 8. Received treatment with estrogens, androgens, or anti-androgenic agents within the previous 12 weeks (Subjects who have been treated with the above agents for more than 12 consecutive weeks prior to start of investigational product are allowed to enrol as long as they do not expect to change dose, drug, or discontinue use during the study). 9. Using any medication that in the opinion of the investigator may affect this clinical study or evaluation of the study. 10. Plan to use medications that are reported to exacerbate acne (e.g., vitamin D, vitamin B12, corticosteroids, androgens, haloperidol, halogens, lithium, hydantoin, and phenobarbital). 11. Have a history of substance abuse (alcohol or drugs) or substance dependence within 12 months prior to screening. 12. Have a known hypersensitivity or have had previous allergic reaction to any of the components of the investigational product. 13. Used any investigational therapy within the previous 12 weeks, or plan to participate in another clinical study at the same time. 14. Participated in another Japanese clinical studies planned by GlaxoSmithKline K.K. in the development of investigational products for acne vulgaris. 15. Are employees of GlaxoSmithKline, an investigator, or contract research organization (CRO) involved in the study, or any immediate family member of an employee involved in the study. 16. Have other conditions that would put the subject at unacceptable risk for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the early efficacy of Duac Combination Gel once daily (QD) to the combination therapy of ADA QD and CLDM twice daily (BID) at Week 2.;Secondary Objective: To compare efficacy and Global Improvement of Duac Combination Gel QD to the combination therapy of ADA 0.1% QD and CLDM 1% BID. To evaluate safety and tolerability of Duac Combination Gel QD and the combination therapy of ADA 0.1% QD and CLDM 1% BID.;Primary end point(s): The percent (%) change in total lesion counts from baseline to Weeks 2.;Timepoint(s) of evaluation of this end point: Baseline, Weeks 1,2,4,8, and 12 or end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The percent (%) change in total lesion counts from baseline to Weeks 1, 4, 8, and 12 (or end of the study). The percent (%) change in lesion counts (inflammatory and non-inflammatory) from baseline to Weeks 1, 2, 4, 8, and 12 (or end of the study). The absolute change in lesion counts (total, inflammatory, and non-inflammatory) from baseline to Weeks 1, 2, 4, 8, and 12 (or end of the study). The proportion of subjects who have a minimum 2-grade improvement in Investigator’s Static Global Assessment (ISGA) score from baseline to Weeks 1, 2, 4, 8, and 12 (or end of the study). Adverse events (AEs) – nature, severity and frequency. Local tolerability (erythema, dryness, peeling, itching, and burning/stinging) score over all study time points. The proportion of subjects who have an ISGA score of 0 or 1 at Weeks 1, 2, 4, 8, and 12 (or end of the study). The proportion of subjects who have a reduction in lesion counts (total lesions, inflammatory lesions or non- inflammatory lesions) of at least 50% from baseline to Weeks 1, 2, 4, 8, and 12 (end of the study). ;Timepoint(s) of evaluation of this end point: Weeks 1, 2, 4, 8 and 12 or end of study. | — |
Countries
Japan
Contacts
Public ContactGSK Clinical Support
GlaxoSmithKline Research & Development Limited
Outcome results
None listed