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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Acne Vulgaris, Acne

Intervention / Treatment
-----------------
* Drug: CT Gel
* Drug: Clindamycin Gel (clindamycin )
* Drug: Tretinoin Gel (tretinoin)
* Drug: Vehicle Gel


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CT Gel | Drug: CT Gel<br>* Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks<br>|
| Active Comparator: 2<br>Clindamycin Gel (clindamycin) | Drug: Clindamycin Gel (clindamycin )<br>* Clindamycin 1% gel applied topically once daily in the evening for 12 weeks<br>|
| Active Comparator: 3<br>Tretinoin Gel (tretinoin) | Drug: Tretinoin Gel (tretinoin)<br>* Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks<br>|
| Placebo Comparator: 4<br>Vehicle Gel | Drug: Vehicle Gel<br>* Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | 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. | Baseline, Week 12 | 
| 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 | 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. | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | 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. | Baseline, Week 12 | 
| The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 | 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. | Week 12 | 
| The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 | 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. | Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne Vulgaris, Acne