Comparison of the Efficacy and Safety of Duac™ Once Daily Gel with Clindamycin Phosphate gel twice daily in Treatment of Acne.
- Conditions
- acne vulgarisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-004909-16-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline R&D Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 1020
1. Male and female subjects between 12 and 45 years of age, inclusive age were calculated by date of birth, from 0 at birth.
2. Subjects who had:
i. A minimum of 17 but not more than 60 facial inflammatory lesions (papules plus pustules), and no more than 1 facial nodular lesion, with NO cystic lesions.
and
ii. A minimum of 20 but not more than 125 facial noninflammatory lesions (open and closed comedones).
3. Subjects who had an ISGA score of 2 or 3 at Baseline.
4. Subjects 18 years of age or older had to provide written informed consent (according to any local or national authorization requirements). Subjects under the legal age of consent had to provide assent and have written informed consent of both the subject and a parent or the legal guardian (according to any local or national authorization requirements).
5. Subjects who were willing and able to complete the study, to understand and comply with the requirements of the study, abide by the restrictions, apply the medication as instructed, and return for the required study visits.
6. Subjects who were in good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
7. Female subjects of childbearing potential had to have a negative pregnancy test at Baseline. Sexually active females of childbearing potential participating in the study had to use a medically acceptable method of contraception for at least 6 consecutive months prior to start of study treatment, and had to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential was defined as one who was biologically capable of becoming pregnant; including perimenopausal women who were less than 2 years from their last menses. Medically acceptable contraceptive methods include the following:
• Hormonal contraception, including oral, injectable, or implantable methods started at least 6 months prior to screening.
• Reliable barrier methods include condoms and diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they were used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal ligation or partner’s vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermatocide were acceptable.
Females who were not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study.
Subjects who had been treated with estrogens, androgens, or anti-androgenic agents used for prevention of pregnancy (and not for control of acne) for at least 6 consecutive months prior to the first dose of investigational product might enrol as long as they did not expect to change dose, drug, or discontinue use during the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 56
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 960
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Female subjects who were pregnant, trying to become pregnant, or who were lactating.
2. Subjects who had cystic acne lesions, acne conglobata, acne fulminans, or secondary acne (e.g. chloracne or drug-induced acne).
3. Subjects who had 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 had facial hair that may prevent the accurate assessment of acne vulgaris grade or lesion count.
5. Subjects who had a history or presence of regional enteritis or inflammatory bowel disease (e.g. ulcerative colitis, pseudomembranous colitis, chronic diarrhoea, or a history of antibiotic-associated colitis, bloody diarrhoea) or similar symptoms.
6. Subjects who had used a prohibited medication, or undergone a prohibited procedure or treatment within the required washout period.
7. Subjects who had a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, or excipients of the investigational product.
8. Subjects who were employees of a clinical research organization involved in the study, Stiefel, or GSK or who are an immediate family member (partner, offspring, parents, siblings, or sibling’s offspring) of an employee, the investigator, or his/her study staff.
9. Subjects who had a member of the same household in this study at the same time.
10. Subjects who had used traditional remedies known to affect acne vulgaris within the last 4 weeks.
11. Subjects who had had any major illness within 30 days before study enrolment.
12. Subjects who had any other condition that in the judgement of the investigator would put the subject at unacceptable risk for participation in the study.
13. Subjects who had participated in any clinical trials or taken any investigate drugs within 4 weeks before study enrolment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Duac Once Daily Gel compared with clindamycin phosphate gel in the topical treatment of mild to moderate acne vulgaris.;Secondary Objective: To evaluate the safety and tolerability of Duac Once Daily Gel compared with clindamycin phosphate gel in the topical treatment of mild to moderate acne vulgaris.;Primary end point(s): 1) Absolute change in inflammatory and noninflammatory (total) lesion counts from Baseline to Week 12 (LOCF)<br>2) Proportion of an improvement in ISGA score of =2 grades from Baseline at Week 12 (LOCF);Timepoint(s) of evaluation of this end point: From Baseline (week 0) to Week 12
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: From baseline (week 0), week 1, 2, 4 and 8.;Secondary end point(s): • Absolute change in inflammatory lesion counts from Baseline to Week 12 (LOCF)<br>• Absolute change in noninflammatory lesion counts from Baseline to Week 12 (LOCF)<br>• Percent change in total lesion counts from Baseline to Week 12 (LOCF)<br>• Percent change in inflammatory lesion counts from Baseline to Week 12 (LOCF)<br>• Percent change in noninflammatory lesion counts from Baseline to Week 12 (LOCF)