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CompletedNCT02661958Updated Sep 19, 2019

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

A Phase 2 interventional study of S6G5T-3 and S6G5T-1 in Acne Vulgaris, sponsored by Sol-Gel Technologies, Ltd.. Completed at 34 sites in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2019-09-19.

Sponsored by Sol-Gel Technologies, Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
726
Allocation
Randomized
Ages
9 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acne Vulgaris

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Keywords

  • acne vulgaris
  • acne
03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 726 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Sol-Gel Technologies, Ltd. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male and female subjects 9 years of age or older.
  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

Exclusion Criteria:

  1. More than two acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 mm in diameter)
  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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
726 participants (actual)

Study arms

  • Experimental
    S6G5T-3

    topical cream

    Drug: S6G5T-3

  • Experimental
    S6G5T-1

    topical cream

    Drug: S6G5T-1

  • Active comparator
    S6G5T-5

    topical cream

    Drug: S6G5T-5

  • Active comparator
    S6G5T-7

    topical cream

    Drug: S6G5T-7

  • Active comparator
    S6G5T-6

    topical cream

    Drug: S6G5T-6

  • Placebo comparator
    S6G5T-8

    topical cream

    Drug: S6G5T-8

Interventions

  • DrugS6G5T-3

    once a day topical cream

  • DrugS6G5T-1

    once a day topical cream

  • DrugS6G5T-5

    once a day topical cream

  • DrugS6G5T-6

    once a day topical cream

  • DrugS6G5T-7

    once a day topical cream

  • DrugS6G5T-8

    once a day topical cream

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: week 12

  2. 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)

    Time frame: baseline and week 12

Secondary outcomes

  1. 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)

    Time frame: Baseline and week 12

  2. 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.

    Time frame: baseline, week 4, 8

07

Study locations

34 sites
  • Orange County Research Institute
    Anaheim, California 92801, United States
  • Core Healthcare Group
    Cerritos, California 90703, United States
  • eStudySite
    Chula Vista, California 91911, United States
  • T. Joseph Raoof MD, Inc./Encino Research Center
    Encino, California 91436, United States
  • Dermatology Research Associates
    Los Angeles, California 90045, United States
  • eStudySite
    Oceanside, California 92056, United States
  • Empire Clinical Research
    Upland, California 91786, United States
  • Horizons Clinical Research Center, LLC
    Denver, Colorado 80220, United States
  • MOORE Clinical Research, Inc
    Brandon, Florida 33511, United States
  • Health Awareness, Inc.
    Jupiter, Florida 33458, United States
  • LCC Medical Research Institute, LLC
    Miami, Florida 33126, United States
  • Oceane7 Clinical Research
    Miami, Florida 33144, United States
  • RM Medical Research, LLC
    Miami, Florida 33175, United States
  • IMIC Inc.
    Palmetto Bay, Florida 33157, United States
  • Clinical Research Trials of Florida, Inc.
    Tampa, Florida 33607, United States
  • Meridien Research
    Tampa, Florida 33634, United States
  • Heartland Research Associates, LLC
    Augusta, Kansas 67010, United States
  • Dermatology Specialists Research
    Louisville, Kentucky 40202, United States
  • DermResearch, PLLC
    Louisville, Kentucky 40217, United States
  • DelRicht Research
    New Orleans, Louisiana 70115, United States
  • MediSearch clinical Trials
    Saint Joseph, Missouri 64506, United States
  • Quality Clinical Research Inc.
    Omaha, Nebraska 68114, United States
  • eStudySite
    Las Vegas, Nevada 89109, United States
  • ActivMed Practices and Research, Inc.
    Portsmouth, New Hampshire 3801, United States
  • New York Clinical Trials
    Manhattan, New York 10018, United States
  • Derm Research Center of New York, Inc
    Stony Brook, New York 11790, United States
  • Dermatology Consulting Services
    High Point, North Carolina 27262, United States
  • Wake Research Associates, LLC
    Raleigh, North Carolina 27612, United States
  • Paddington Testing Co, Inc
    Philadelphia, Pennsylvania 19103, United States
  • Palmetto Clinical Trial Services, LLC @ Greenville Dermatology
    Greenville, South Carolina 29607, United States
  • Discover Research, Inc.
    Bryan, Texas 77802, United States
  • West Houston Clinical Research Services LLC
    Houston, Texas 77055, United States
  • Austin Institute for Clinical Research, Inc.
    Pflugerville, Texas 78660, United States
  • Texas Dermatology and Laser Specialists
    San Antonio, Texas 78218, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02661958
Lead sponsor
Sol-Gel Technologies, Ltd.
Collaborators
Accelovance
Responsible party
Sponsor
First posted
Jan 25, 2016
Start date
May 2016
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Sep 19, 2019

Study contacts

Piyush Sheladia, M.S.
study chair · Accelovance

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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