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

Stiefel

Status and phase: Completed; Phase 3

Conditions: Acne; Acne Vulgaris

Treatments: Drug: Tretinoin Gel (tretinoin); Drug: Vehicle Gel; Drug: CT Gel; Drug: Clindamycin Gel (clindamycin )

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689117

114681

W0265-03 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,649 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,649 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

CT Gel

Treatment:

Drug: CT Gel

2

Active Comparator group

Description:

Clindamycin Gel (clindamycin)

Treatment:

Drug: Clindamycin Gel (clindamycin )

3

Active Comparator group

Description:

Tretinoin Gel (tretinoin)

Treatment:

Drug: Tretinoin Gel (tretinoin)

4

Placebo Comparator group

Description:

Vehicle Gel

Treatment:

Drug: Vehicle Gel