Official Title: “A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of 0.1% Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris”

This is a single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel/Tazorac Cream and Acanya Gel/Tazorac Cream for the treatment of facial acne vulgaris. Approximately 40 male and female subjects will be enrolled (20 per study group).

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2010

This is a single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel/Tazorac Cream and Acanya Gel/Tazorac Cream for the treatment of facial acne vulgaris. Approximately 40 male and female subjects will be enrolled (20 per study group).

Subjects will participate in the study for 12 weeks; visits will be scheduled at baseline and at weeks 1, 2, 4, 8, and 12 (total of 6 visits). Eligible subjects will be randomized at baseline to 1 of the 2 study groups in a 1:1 ratio (Duac Gel/Tazorac Cream to Acanya Gel/Tazorac Cream). Subjects will apply either Duac Gel or Acanya Gel to the face each morning and apply Tazorac Cream to the face each evening.

Tolerability will be evaluated through subject assessments of burning/stinging, itching, and oiliness and through investigator assessments of peeling, erythema, and dryness. In addition, subjects will evaluate their overall skin comfort and record the usage of moisturizer and sunscreen, if needed. Efficacy will be assessed through lesion counts (total, inflammatory and noninflammatory) and ISGA. Safety will be assessed by evaluating adverse events (AEs), concomitant medication use, and withdrawals from the study.

This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation. Subjects (and parents or legal guardians) and study-center staff will be instructed not to reveal study product allocation to the investigator.

Intervention(s) in this Clinical Trial

• Drug: Tazorac Cream and Duac Topical Gel
  • Subjects will participate in the study for 12 weeks. In the morning, and as per treatment allocation, subjects will apply a thin film (pea sized amount) of Duac Gel to the entire face. In the evening, subjects will apply a thin film (pea sized amount) of Tazorac Cream to the entire face.
• Drug: Tazorac Cream (tazarotene 0.1%) plus Acanya Gel (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%).
  • Subjects will participate in the study for 12 weeks. In the morning, subjects will apply a thin film (pea sized amount) of Acanya Gel to the entire face. In the evening, subjects will apply a thin film (pea sized amount) of Tazorac Cream to the entire face.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Tazorac Cream and Duac Topical Gel
• Active Comparator: 2
  • Tazorac Cream (tazarotene 0.1%) plus Acanya Gel (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%)

Primary Measures

• To compare the tolerability of Duac Gel / 0.1% Tazorac Cream combination therapy with that of Acanya Gel / 0.1% Tazorac Cream combination therapy for the treatment of facial acne vulgaris
  • Time Frame: Week 1, Week 2, Week 4, Week 8, and Week 12
    Safety Issue?: Yes

Secondary Measures

• To evaluate the efficacy of Duac Gel / 0.1% Tazorac Cream combination therapy and Acanya Gel / 0.1% Tazorac Cream combination therapy for the treatment of facial acne vulgaris.
  • Time Frame: Week 1, Week 2, Week 4, Week 8, and Week 12
    Safety Issue?: Yes

Inclusion Criteria:

• Male or female 12-45 years of age at time of consent.
• Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed.
• Documented diagnosis of acne vulgaris.
• Lesion count: 20 to 50 inflammatory and 30 to 100 noninflammatory facial lesions excluding nose, and ≤ 1 small nodular lesion. Cystic lesions are not allowed at baseline.
• Investigator Static Global Assessment of 3 or 4 at Baseline.
• Female subjects of childbearing potential must have a regular menstrual cycle and a negative urine pregnancy test within 2 weeks prior to study entry.
• Sexually active females of childbearing potential participating in the study must agree to use a medically-acceptable method of contraception while receiving protocol-assigned product.
• Women who are not currently sexually active must agree to use a medically-acceptable method of contraception should they become sexually active while participating in the study.

Exclusion Criteria:

• Female who is pregnant, trying to become pregnant, or breast feeding.
• Clinically relevant finding at baseline or medical history of severe systemic diseases or diseases of the facial skin, other than acne vulgaris.
• Facial hair that may obscure the accurate assessment of acne grade.
• History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, celiac disease or a history of antibiotic-associated colitis) or similar symptoms.
• Concurrent use of medications known to be photosensitizers because of the possibility of increased phototoxicity.
• Concomitant use of neuromuscular blocking agents.
• Use of topical anti-acne medications within the past 2 weeks.
• Use of topical antibiotics on the face within the past 2 weeks or systemic antibiotics within the past 4 weeks.
• Use of topical corticosteroids on the face or systemic corticosteroids within the past 2 to 4 weeks, respectively. Use of inhaled, intra-articular or intra lesional (other than for facial acne lesions) steroids is acceptable.
• Use of systemic retinoids, such as Isotretinoin, within the past 6 months.
• Concomitant use of facial products such as astringents, toners, peels, masks, washes or soaps containing benzoyl peroxide, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β hydroxy acids.
• Concomitant use of medications that are reported to exacerbate acne, as these may impact efficacy assessments. Iron supplements and folate are acceptable.
• Facial procedures (eg, chemical peel, lasers/lights, photodynamic therapy, microdermabrasion, artificial ultraviolet therapy) within the past 4 weeks.
• Known hypersensitivity or previous allergic reaction to any component(s) or excipient(s) of the study products.
• Use of any investigational medications or treatments within the past 4 weeks.
• Treatment with estrogens for 12 weeks or less immediately prior to starting study product and have not been prescribed for the treatment of Acne Vulgaris. Subjects that have been treated with estrogens, androgens, or anti androgenic agents for more than 12 weeks prior to start of study treatment are allowed to enroll as long as they do not expect to change dose, medication, or discontinue use during the study.
• Evidence of recent alcohol or drug abuse.
• Live in the same household as currently enrolled subjects.
• Employee of the investigator, a clinical research organization, or Stiefel, who is involved in the study or an immediate family member of an employee involved in the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Stiefel, a GSK Company

Overall Clinical Trial Officials and Contacts

Lou Barbato, MD Study Director Stiefel, a GSK Company  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01016977

Study ID Number: C0000-411

ClinicalTrials.gov Identifier: NCT01016977

Health Authority: United States: Institutional Review Board