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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: S6G5T-3; Drug: S6G5T-1; Drug: S6G5T-5; Drug: S6G5T-7; Drug: S6G5T-6; Drug: S6G5T-8

• Study Type: Interventional
• Enrollment (Actual): 726
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sol-Gel Technologies, Ltd.
• Collaborators: Accelovance
• Investigators: Study Chair: Piyush Sheladia, M.S., Accelovance

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimate): January 25, 2016

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: acne; acne vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: SGT-65-02