Efficacy, Safety, and Tolerability of S6G5T-1 and S6G5T-3 for the Treatment of Acne Vulgaris
- Conditions
- Acne Vulgaris
- Interventions
- Registration Number
- NCT02661958
- Lead Sponsor
- Sol-Gel Technologies, Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 726
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Male and female subjects 9 years of age or older.
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In good general health Based on medical records
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Have a diagnosis of facial acne with >25 and <100 non-inflammatory lesions and >20 and <50 inflammatory lesions.
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Have a score of "3" or "4" (Moderate or Severe) on the IGA scale.
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Have two or fewer cysts or nodules (defined as an inflammatory lesion greater than or equal to 5 mm in diameter).
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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,
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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
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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).
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Male subjects must be clean-shaven and agree to remain so for during the study visits.
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S6G5T-5 S6G5T-5 topical cream S6G5T-7 S6G5T-7 topical cream S6G5T-3 S6G5T-3 topical cream S6G5T-1 S6G5T-1 topical cream S6G5T-8 S6G5T-8 topical cream S6G5T-6 S6G5T-6 topical cream
- Primary Outcome Measures
Name Time Method Absolute change in lesion count (separately for inflammatory and non-inflammatory) baseline and week 12 Absolute change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)
Investigator's Global Assessment (IGA) week 12 Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA at Week 12
- Secondary Outcome Measures
Name Time Method Percentage change from Baseline in lesion count on the face at Week 12 Baseline and week 12 Percentage change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)
assessments of IGA at each time point baseline, week 4, 8 Supportive efficacy variables are the assessments of IGA percentage change at each time point during the treatment period, namely at Weeks 4, and 8.
Trial Locations
- Locations (32)
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
West Houston Clinical Research Services LLC
🇺🇸Houston, Texas, United States
LCC Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
Oceane7 Clinical Research
🇺🇸Miami, Florida, United States
RM Medical Research, LLC
🇺🇸Miami, Florida, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
MediSearch clinical Trials
🇺🇸Saint Joseph, Missouri, United States
T. Joseph Raoof MD, Inc./Encino Research Center
🇺🇸Encino, California, United States
Palmetto Clinical Trial Services, LLC @ Greenville Dermatology
🇺🇸Greenville, South Carolina, United States
Derm Research Center of New York, Inc
🇺🇸Stony Brook, New York, United States
eStudySite
🇺🇸Las Vegas, Nevada, United States
New York Clinical Trials
🇺🇸Manhattan, New York, United States
MOORE Clinical Research, Inc
🇺🇸Brandon, Florida, United States
IMIC Inc.
🇺🇸Palmetto Bay, Florida, United States
Paddington Testing Co, Inc
🇺🇸Philadelphia, Pennsylvania, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
Discover Research, Inc.
🇺🇸Bryan, Texas, United States
Heartland Research Associates, LLC
🇺🇸Augusta, Kansas, United States
Dermatology Consulting Services
🇺🇸High Point, North Carolina, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Empire Clinical Research
🇺🇸Upland, California, United States
ActivMed Practices and Research, Inc.
🇺🇸Portsmouth, New Hampshire, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Austin Institute for Clinical Research, Inc.
🇺🇸Pflugerville, Texas, United States
Horizons Clinical Research Center, LLC
🇺🇸Denver, Colorado, United States
Clinical Research Trials of Florida, Inc.
🇺🇸Tampa, Florida, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Dermatology Specialists Research
🇺🇸Louisville, Kentucky, United States
DermResearch, PLLC
🇺🇸Louisville, Kentucky, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Quality Clinical Research Inc.
🇺🇸Omaha, Nebraska, United States