Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02661958
Recruitment Status : Completed
First Posted : January 25, 2016
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Accelovance
Information provided by (Responsible Party):
Sol-Gel Technologies, Ltd.

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE January 25, 2016
Last Update Posted Date September 19, 2019
Study Start Date  ICMJE May 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2016)
  • Investigator's Global Assessment (IGA) [ Time Frame: 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
  • Absolute change in lesion count (separately for inflammatory and non-inflammatory) [ Time Frame: baseline and week 12 ]
    Absolute change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02661958 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2016)
  • Percentage change from Baseline in lesion count on the face at Week 12 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, and Tolerability of S6G5T-1 and S6G5T-3 for the Treatment of Acne Vulgaris
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: S6G5T-3
    once a day topical cream
  • Drug: S6G5T-1
    once a day topical cream
  • Drug: S6G5T-5
    once a day topical cream
  • Drug: S6G5T-6
    once a day topical cream
  • Drug: S6G5T-7
    once a day topical cream
  • Drug: S6G5T-8
    once a day topical cream
Study Arms  ICMJE
  • Experimental: S6G5T-3
    topical cream
    Intervention: Drug: S6G5T-3
  • Experimental: S6G5T-1
    topical cream
    Intervention: Drug: S6G5T-1
  • Active Comparator: S6G5T-5
    topical cream
    Intervention: Drug: S6G5T-5
  • Active Comparator: S6G5T-7
    topical cream
    Intervention: Drug: S6G5T-7
  • Active Comparator: S6G5T-6
    topical cream
    Intervention: Drug: S6G5T-6
  • Placebo Comparator: S6G5T-8
    topical cream
    Intervention: Drug: S6G5T-8
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2019)
726
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2016)
660
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02661958
Other Study ID Numbers  ICMJE SGT-65-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sol-Gel Technologies, Ltd.
Study Sponsor  ICMJE Sol-Gel Technologies, Ltd.
Collaborators  ICMJE Accelovance
Investigators  ICMJE
Study Chair: Piyush Sheladia, M.S. Accelovance
PRS Account Sol-Gel Technologies, Ltd.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP