A multi-center, randomized, evaluator-blind, parallel group study evaluation of the efficacy, safety, and tolerability of DUAC® Akne Gel and Epiduo® Gel in the topical treatment of facial acne vulgaris

• Conditions: acne vulgaris; MedDRA version: 9.1Level: LLTClassification code 10000519Term: Acne vulgaris

• Registration Number: EUCTR2008-002359-26-DE
• Lead Sponsor: Stiefel Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-26
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects who are males or females 12 to 45 years of age, inclusive, in good general health.
2. Subjects who are capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed. NOTE - Subjects under 18 years of age must provide assent and have the written, informed consent of the parent(s) or legal guardian responsible for their custody.
3. Subjects who are willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
4. Subjects who have: A minimum of 25 to a maximum of 80 inflammatory facial lesions (papules and pustules), including the nose, and no facial nodular cystic lesions. AND A minimum of 12 to a maximum of 100 non-inflammatory facial lesions (open and closed comedones), excluding the nasal area.
5. Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which include oral contraception, injectable or implantable methods, intrauterine devices, double-barrier methods, or condom plus spermatocide) for more than 12 consecutive weeks prior to start of study treatment and are allowed to enroll only if they do not expect to change dose, drug, or discontinue using contraception during the study.
6. Subjects who have been treated with estrogens, androgens, or anti?androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
7. Subjects who have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
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

1. Female subjects who are pregnant, trying to become pregnant, or who are lactating.
2. 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.
3. Subjects who have facial hair that may obscure the accurate assessment of acne grade.
4. 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.
5. Subjects who have used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
6. Subjects who have used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra?articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
7. Subjects who have used systemic retinoids within the past 6 months.
8. Subjects who are using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
9. Subjects who are using neuromuscular blocking agents. Clindamycin
has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
10. Subjects who have used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
11. Subjects who have used any investigational therapy within 4 weeks of study day 1.
12. Subjects who are using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or a- or ß-hydroxy acids.
13. Subjects who are using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital) as these may impact efficacy assessments.
14. Subjects who have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
15. Subjects who have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
16. Subjects who are employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling’s offspring) of an employee, the investigator, or his/her study staff.
17. Subjects who have a member of the same household in this study.

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 Akne Gel compared with Epiduo Gel in the treatment of facial acne vulgaris by assessing the percent change in inflammatory lesion count (papules and pustules, including nasal lesions) from baseline to week 12.;Secondary Objective: To evaluate the safety and tolerability of Duac Akne Gel compared with Epiduo Gel.;Primary end point(s): The primary endpoint of percent change in inflammatory lesion count from baseline to week 12 will be analyzed at an alpha level of 0.05 using analysis of covariance (ANCOVA) with treatment, center, and baseline lesion count in the model. The assumption of normality will be verified using the Shapiro-Wilk test with a threshold value of 0.1. If the assumption is not met, the data will be ln-transformed for the primary analysis. If the In-transformed data are also not normal, the data will instead be rank?transformed. Missing values will be imputed using the Last Observation Carried Forward (LOCF) method.