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

NCT01016977 | Completed Phase 4 Results

• 1 other identifier: 114566
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (7)

• Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12

  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.

  Baseline and Weeks 1, 2, 4, 8, and 12

• Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12

  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.

  Baseline and Weeks 1, 2, 4, 8, and 12

• Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12

  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.

  Baseline and Weeks 1, 2, 4, 8, and 12

• Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12

  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.

  Baseline and Weeks 1, 2, 4, 8, and 12

• Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12

  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.

  Baseline and Weeks 1, 2, 4, 8, and 12

• Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12

  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.

  Baseline and Weeks 1, 2, 4, 8, and 12

• Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12

  Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Skin comfort was assessed by participants based on 5-point scale: +2, very comfortable; +1, comfortable; 0, neutral; -1, somewhat uncomfortable; or -2, uncomfortable.

  Baseline and Weeks 1, 2, 4, 8, and 12

Secondary Outcomes (8)

• Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12

  Baseline and Week 12

• Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12

  Baseline and Weeks 1, 2, 4, 8, and 12

• Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12

  Baseline and Weeks 1, 2, 4, 8, and 12

• Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12

  Baseline and Week 12

• Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12

  Baseline and Week 12

Study Arms (2)

Duac & taz

ACTIVE COMPARATOR

Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene

Drug: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene

Acanya & taz

ACTIVE COMPARATOR

clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene

Drug: clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene

Interventions

Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene DRUG

Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene

Duac & taz

clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene DRUG

clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene

Acanya & taz

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Related Publications (1)

• 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.

  PMID: 23513559 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin; Benzoyl Peroxide; tazarotene; clindamycin phosphate

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 20, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 30, 2017
• Results First Posted: February 23, 2012

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share