Efficacy, Safety, and Tolerability of S6G5T-1 and S6G5T-3 for the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the superiority in efficacy and assess safety and tolerability of the products S6G5T-3 and S6G5T-1 as compared to their respective active components or the vehicle for the treatment of acne.

Official Title
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A Phase 2, Randomized, Multicenter, Double-Blind, Active and Vehicle Controlled Parallel-group Study Evaluating the Efficacy, Safety, and Tolerability of Products S6G5T-3 and S6G5T-1 for the Treatment of Acne Vulgaris for 12 Weeks

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: S6G5T-3
* Drug: S6G5T-1
* Drug: S6G5T-5
* Drug: S6G5T-6
* Drug: S6G5T-7
* Drug: S6G5T-8


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects 9 years of age or older. In good general health Based on medical records Have a diagnosis of facial acne with >25 and <100 non-inflammatory lesions and >20 and <50 inflammatory lesions. Have a score of 3 or 4 (Moderate or Severe) on the IGA scale. Have two or fewer cysts or nodules (defined as an inflammatory lesion greater than or equal to 5 mm in diameter). Sexually active women of child-bearing potential must use one of the following birth control options: One of these highly effective contraception methods: i. Intrauterine device (IUD); ii. Hormonal, for at least 3 months (Pills, injections, implants, transdermal patch, vaginal ring); iii. Tubal ligation; iv. Partner vasectomy, OR A barrier form of contraception (listed below) i. Male or female condom; ii. Diaphragm with spermicides; iii. Cervical cap with spermicides; iv. Contraceptive sponge Willingness and capacity for protocol compliance (for subjects under the age of consent, the parent/guardian must be willing and able to comply with study requirements). Male subjects must be clean-shaven and agree to remain so for during the study visits. Consent to participate, verified by signing an approved written Informed Consent Form and HIPAA; for subjects under the age of consent, both a signed assent form and a signed Informed Consent Form from the parent/guardian are required in accordance with local and federal regulations. Exclusion Criteria: More than two acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 mm in diameter) Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc or severe acne requiring systemic treatment. Underlying disease that requires the use of interfering topical or systemic therapy. Other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis, or rosacea. Beard, facial hair, or tattoo that may interfere with study assessments. Use of tanning booths or tanning lamps within one week prior to Baseline and an unwillingness to refrain from use during the study. Use of hormonal contraceptives, unless subject is on a stable dose for at least three months prior to enrollment. Use of hormonal contraceptives solely for the control of acne. Use of prohibited medications prior to the study and unwillingness to refrain from use during the study. Known sensitivities to the study drug ingredients. Allergy to benzoyl peroxide, tretinoin, parabens and glycerin or other ingredients listed in the investigator brochure. Clinically significant abnormal findings or conditions (other than acne), which might, in the opinion of the investigator, interfere with study evaluations or pose a risk to subject safety during the study. Female subjects who are pregnant and/or nursing or planning to become pregnant during the course of the trial. Subjects who test positive for pregnancy after start of test treatment will be discontinued from test treatment but will be followed for safety purposes. Participation in another investigational drug or device research study within 30 days of enrollment or five half-lives of the drug, whichever is longer. Current or history of facial skin cancer. Is an employee or family member of the study investigator or other study staff having direct involvement in the proposed study. Is a family member of a study participant recruited and enrolled into the proposed study.

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S6G5T-3<br>topical cream | Drug: S6G5T-3<br>* once a day topical cream<br>|
| Experimental: S6G5T-1<br>topical cream | Drug: S6G5T-1<br>* once a day topical cream<br>|
| Active Comparator: S6G5T-5<br>topical cream | Drug: S6G5T-5<br>* once a day topical cream<br>|
| Active Comparator: S6G5T-7<br>topical cream | Drug: S6G5T-7<br>* once a day topical cream<br>|
| Active Comparator: S6G5T-6<br>topical cream | Drug: S6G5T-6<br>* once a day topical cream<br>|
| Placebo Comparator: S6G5T-8<br>topical cream | Drug: S6G5T-8<br>* once a day topical cream<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment (IGA) | Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA at Week 12 | week 12 | 
| Absolute change in lesion count (separately for inflammatory and non-inflammatory) | Absolute change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions) | baseline and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from Baseline in lesion count on the face at Week 12 | Percentage change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions) | Baseline and week 12 | 
| assessments of IGA at each time point | Supportive efficacy variables are the assessments of IGA percentage change at each time point during the treatment period, namely at Weeks 4, and 8. | baseline, week 4, 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne vulgaris, acne