Efficacy, Safety, and Tolerability of S6G5T-1 and S6G5T-3 for the Treatment of Acne Vulgaris
NCT ID: NCT02661958
Last Updated: 2019-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
726 participants
INTERVENTIONAL
2016-05-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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S6G5T-3
topical cream
S6G5T-3
once a day topical cream
S6G5T-1
topical cream
S6G5T-1
once a day topical cream
S6G5T-5
topical cream
S6G5T-5
once a day topical cream
S6G5T-7
topical cream
S6G5T-7
once a day topical cream
S6G5T-6
topical cream
S6G5T-6
once a day topical cream
S6G5T-8
topical cream
S6G5T-8
once a day topical cream
Interventions
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S6G5T-3
once a day topical cream
S6G5T-1
once a day topical cream
S6G5T-5
once a day topical cream
S6G5T-6
once a day topical cream
S6G5T-7
once a day topical cream
S6G5T-8
once a day topical cream
Eligibility Criteria
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Inclusion Criteria
2. In good general health Based on medical records
3. Have a diagnosis of facial acne with \>25 and \<100 non-inflammatory lesions and \>20 and \<50 inflammatory lesions.
4. Have a score of "3" or "4" (Moderate or Severe) on the IGA scale.
5. Have two or fewer cysts or nodules (defined as an inflammatory lesion greater than or equal to 5 mm in diameter).
6. 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,
7. 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
8. 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).
9. Male subjects must be clean-shaven and agree to remain so for during the study visits.
10. 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
2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc or severe acne requiring systemic treatment.
3. Underlying disease that requires the use of interfering topical or systemic therapy.
4. 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.
5. Beard, facial hair, or tattoo that may interfere with study assessments.
6. Use of tanning booths or tanning lamps within one week prior to Baseline and an unwillingness to refrain from use during the study.
7. Use of hormonal contraceptives, unless subject is on a stable dose for at least three months prior to enrollment.
8. Use of hormonal contraceptives solely for the control of acne.
9. Use of prohibited medications prior to the study and unwillingness to refrain from use during the study.
10. Known sensitivities to the study drug ingredients. Allergy to benzoyl peroxide, tretinoin, parabens and glycerin or other ingredients listed in the investigator brochure.
11. 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.
12. 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.
13. Participation in another investigational drug or device research study within 30 days of enrollment or five half-lives of the drug, whichever is longer.
14. Current or history of facial skin cancer.
15. Is an employee or family member of the study investigator or other study staff having direct involvement in the proposed study.
16. Is a family member of a study participant recruited and enrolled into the proposed study.
9 Years
ALL
No
Sponsors
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Accelovance
INDUSTRY
Sol-Gel Technologies, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Piyush Sheladia, M.S.
Role: STUDY_CHAIR
Accelovance
Locations
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Orange County Research Institute
Anaheim, California, United States
Core Healthcare Group
Cerritos, California, United States
eStudySite
Chula Vista, California, United States
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, United States
Dermatology Research Associates
Los Angeles, California, United States
eStudySite
Oceanside, California, United States
Empire Clinical Research
Upland, California, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, United States
MOORE Clinical Research, Inc
Brandon, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, 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
IMIC Inc.
Palmetto Bay, Florida, United States
Clinical Research Trials of Florida, Inc.
Tampa, Florida, United States
Meridien Research
Tampa, Florida, United States
Heartland Research Associates, LLC
Augusta, Kansas, United States
Dermatology Specialists Research
Louisville, Kentucky, United States
DermResearch, PLLC
Louisville, Kentucky, United States
DelRicht Research
New Orleans, Louisiana, United States
MediSearch clinical Trials
Saint Joseph, Missouri, United States
Quality Clinical Research Inc.
Omaha, Nebraska, United States
eStudySite
Las Vegas, Nevada, United States
ActivMed Practices and Research, Inc.
Portsmouth, New Hampshire, United States
New York Clinical Trials
Manhattan, New York, United States
Derm Research Center of New York, Inc
Stony Brook, New York, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, United States
Palmetto Clinical Trial Services, LLC @ Greenville Dermatology
Greenville, South Carolina, United States
Discover Research, Inc.
Bryan, Texas, United States
West Houston Clinical Research Services LLC
Houston, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Countries
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Other Identifiers
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SGT-65-02
Identifier Type: -
Identifier Source: org_study_id
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