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

Completed · Phase 2

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT02661958

Run by

Sol-Gel Technologies, Ltd.

People needed

726

Starts

2016-05-01

Expected to finish

2017-10-01

Last updated by the study team

2019-09-19

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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