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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661958
• Other study ID #: SGT-65-02
• Status: Completed
• Phase: Phase 2
• Start date: May 2016
• Est. completion date: October 2017

Study information

• Verified date: September 2019
• Source: Sol-Gel Technologies, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 726
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Orange County Research Institute	Anaheim	California
United States	Heartland Research Associates, LLC	Augusta	Kansas
United States	MOORE Clinical Research, Inc	Brandon	Florida
United States	Discover Research, Inc.	Bryan	Texas
United States	Core Healthcare Group	Cerritos	California
United States	eStudySite	Chula Vista	California
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	T. Joseph Raoof MD, Inc./Encino Research Center	Encino	California
United States	Palmetto Clinical Trial Services, LLC @ Greenville Dermatology	Greenville	South Carolina
United States	Dermatology Consulting Services	High Point	North Carolina
United States	West Houston Clinical Research Services LLC	Houston	Texas
United States	Health Awareness, Inc.	Jupiter	Florida
United States	eStudySite	Las Vegas	Nevada
United States	Dermatology Research Associates	Los Angeles	California
United States	Dermatology Specialists Research	Louisville	Kentucky
United States	DermResearch, PLLC	Louisville	Kentucky
United States	New York Clinical Trials	Manhattan	New York
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	DelRicht Research	New Orleans	Louisiana
United States	eStudySite	Oceanside	California
United States	Quality Clinical Research Inc.	Omaha	Nebraska
United States	IMIC Inc.	Palmetto Bay	Florida
United States	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas
United States	Paddington Testing Co, Inc	Philadelphia	Pennsylvania
United States	ActivMed Practices and Research, Inc.	Portsmouth	New Hampshire
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	MediSearch clinical Trials	Saint Joseph	Missouri
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Derm Research Center of New York, Inc	Stony Brook	New York
United States	Clinical Research Trials of Florida, Inc.	Tampa	Florida
United States	Meridien Research	Tampa	Florida
United States	Empire Clinical Research	Upland	California

Sponsors (2)

Lead Sponsor	Collaborator
Sol-Gel Technologies, Ltd.	Accelovance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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