A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel - Full Text View

Sponsor:	Stiefel, a GSK Company
Collaborator:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00689117

Purpose

The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.

Condition	Intervention	Phase
Acne Vulgaris Acne	Drug: CT Gel Drug: Clindamycin Gel (clindamycin ) Drug: Tretinoin Gel (tretinoin) Drug: Vehicle Gel	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of CT Gel in Subjects With Acne Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Tretinoin

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.
The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.

Secondary Outcome Measures:

Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.
The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts.
The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion.

Enrollment:	1649
Study Start Date:	April 2008
Study Completion Date:	May 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 CT Gel	Drug: CT Gel Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
Active Comparator: 2 Clindamycin Gel (clindamycin)	Drug: Clindamycin Gel (clindamycin ) Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
Active Comparator: 3 Tretinoin Gel (tretinoin)	Drug: Tretinoin Gel (tretinoin) Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
Placebo Comparator: 4 Vehicle Gel	Drug: Vehicle Gel Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks

Detailed Description:

CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female 12 years of age or older in good general health
Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline

Exclusion Criteria:

Any nodulo-cystic lesions at Baseline
Pregnancy or breast feeding
History or presence of regional enteritis or inflammatory bowel disease or similar symptoms.
Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start.
Use of topical anti-acne medications within the past 2 weeks.
Use of topical or systemic antibiotics on the face within the past 2 weeks.
Use of topical or systemic corticosteroids within the past 2 weeks.
Use of systemic retinoids within the past 3 months.
Use of astringents, toners and skin cleansers for less than 2 weeks prior to the start of the study.
Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
Concomitant use of mega-doses of certain vitamins, such as vitamin D (>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
Concomitant use of tanning booths or sunbathing.
Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, retinoids or excipients of the study product
A significant medical history of or are currently immunocompromised
Current drug or alcohol abuse. (Drug screening not required.)
Use of any investigational therapy within 4 weeks of enrollment.
Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689117

Show 32 Study Locations

Sponsors and Collaborators

Stiefel, a GSK Company

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00689117 History of Changes
Other Study ID Numbers:	114681, W0265-03
Study First Received:	May 24, 2008
Results First Received:	November 2, 2010
Last Updated:	September 22, 2011
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Acne Vulgaris
Acne

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Clindamycin
Clindamycin-2-phosphate
Tretinoin
Protein Synthesis Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 12, 2012