Clinical trial NCT01016977: 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
Official title: A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel / 0.1% Tazorac Cream and Acanya Gel / 0.1% Tazorac Cream for the treatment of facial acne vulgaris.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of acne vulgaris.
* Lesion count: 20 to 50 inflammatory (papules and pustules) and 30 to 100 noninflammatory (open and closed - comedones) 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.

Exclusion Criteria:

* Clinically relevant finding at baseline or medical history of severe systemic diseases or diseases of the facial skin, other than acne vulgaris.
* Subjects with cystic acne lesions.
* 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 (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the possibility of increased phototoxicity.
* Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
* Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, and glycolic acid) 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 the following types of facial products: astringents, toners, abradants, hair removal wax, facials, peels containing glycolic or other acids, 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, (eg, vitamins such as vitamin D, vitamin A, vitamins B2, B6, B12; haloperidol, halogens such as iodide and bromide, lithium, cyclosporine, psoralen, sirolimus, imatinib, aripiprazole, isoniazid, valproate acid, hydantoin, and phenobarbital) 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) performed by an esthetician, beautician, physician, nurse, or other practitioner, 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, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents 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, as described above, androgens, or anti androgenic agents for more than 12 consecutive 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 (in the opinion of the investigator).
* Live in the same household as currently enrolled subjects.
* Employee of the investigator, a clinical research organization, or Stiefel Laboratories who is involved in the study or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.

Primary outcomes:
measure: Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12
timeFrame: Baseline and Weeks 1, 2, 4, 8, and 12
measure: Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12
timeFrame: Baseline and Weeks 1, 2, 4, 8, and 12
measure: Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12
timeFrame: Baseline and Weeks 1, 2, 4, 8, and 12
measure: Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12
timeFrame: Baseline and Weeks 1, 2, 4, 8, and 12
measure: Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12
timeFrame: Baseline and Weeks 1, 2, 4, 8, and 12
measure: Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12
timeFrame: Baseline and Weeks 1, 2, 4, 8, and 12
measure: Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12
timeFrame: Baseline and Weeks 1, 2, 4, 8, and 12
Secondary outcomes:
measure: Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12
timeFrame: Baseline and Weeks 1, 2, 4, 8, and 12
measure: Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12
timeFrame: Baseline and Weeks 1, 2, 4, 8, and 12
measure: Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
timeFrame: Baseline and Week 12
measure: Overall Satisfaction With Study Product at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Dhawan SS, Gwazdauskas J. Clindamycin phosphate 1.2%-benzoyl peroxide (5% or 2.5%) plus tazarotene cream 0.1% for the treatment of acne. Cutis. 2013 Feb;91(2):99-104.