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

• Sponsor: Sol-Gel Technologies, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02661958
• Collaborator: Accelovance (Industry)
• Enrollment: 726
• Locations: 34
• Arms: 6
• Duration (Months): 17
• Patients Per Site: 21.4
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: S6G5T-3; Drug: S6G5T-1; Drug: S6G5T-5; Drug: S6G5T-6; Drug: S6G5T-7; Drug: S6G5T-8	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 726 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Investigator's Global Assessment (IGA) [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

2. Absolute change in lesion count (separately for inflammatory and non-inflammatory) [baseline and week 12]

   Absolute change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)

Secondary Outcome Measures

1. Percentage change from Baseline in lesion count on the face at Week 12 [Baseline and week 12]

   Percentage change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)

2. assessments of IGA at each time point [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: 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:

1. Intrauterine device (IUD); ii. Hormonal, for at least 3 months (Pills, injections, implants, transdermal patch, vaginal ring); iii. Tubal ligation; iv. Partner vasectomy,

1. 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

2. 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).

3. Male subjects must be clean-shaven and agree to remain so for during the study visits.

4. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orange County Research Institute	Anaheim	California	United States	92801
2	Core Healthcare Group	Cerritos	California	United States	90703
3	eStudySite	Chula Vista	California	United States	91911
4	T. Joseph Raoof MD, Inc./Encino Research Center	Encino	California	United States	91436
5	Dermatology Research Associates	Los Angeles	California	United States	90045
6	eStudySite	Oceanside	California	United States	92056
7	Empire Clinical Research	Upland	California	United States	91786
8	Horizons Clinical Research Center, LLC	Denver	Colorado	United States	80220
9	MOORE Clinical Research, Inc	Brandon	Florida	United States	33511
10	Health Awareness, Inc.	Jupiter	Florida	United States	33458
11	LCC Medical Research Institute, LLC	Miami	Florida	United States	33126
12	Oceane7 Clinical Research	Miami	Florida	United States	33144
13	RM Medical Research, LLC	Miami	Florida	United States	33175
14	IMIC Inc.	Palmetto Bay	Florida	United States	33157
15	Clinical Research Trials of Florida, Inc.	Tampa	Florida	United States	33607
16	Meridien Research	Tampa	Florida	United States	33634
17	Heartland Research Associates, LLC	Augusta	Kansas	United States	67010
18	Dermatology Specialists Research	Louisville	Kentucky	United States	40202
19	DermResearch, PLLC	Louisville	Kentucky	United States	40217
20	DelRicht Research	New Orleans	Louisiana	United States	70115
21	MediSearch clinical Trials	Saint Joseph	Missouri	United States	64506
22	Quality Clinical Research Inc.	Omaha	Nebraska	United States	68114
23	eStudySite	Las Vegas	Nevada	United States	89109
24	ActivMed Practices and Research, Inc.	Portsmouth	New Hampshire	United States	3801
25	New York Clinical Trials	Manhattan	New York	United States	10018
26	Derm Research Center of New York, Inc	Stony Brook	New York	United States	11790
27	Dermatology Consulting Services	High Point	North Carolina	United States	27262
28	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
29	Paddington Testing Co, Inc	Philadelphia	Pennsylvania	United States	19103
30	Palmetto Clinical Trial Services, LLC @ Greenville Dermatology	Greenville	South Carolina	United States	29607
31	Discover Research, Inc.	Bryan	Texas	United States	77802
32	West Houston Clinical Research Services LLC	Houston	Texas	United States	77055
33	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas	United States	78660
34	Texas Dermatology and Laser Specialists	San Antonio	Texas	United States	78218

Sponsors and Collaborators

• Sol-Gel Technologies, Ltd.
• Accelovance

Investigators

• Study Chair: Piyush Sheladia, M.S., Accelovance

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sol-Gel Technologies, Ltd.
• ClinicalTrials.gov Identifier: NCT02661958
• Other Study ID Numbers: SGT-65-02
• First Posted: Jan 25, 2016
• Last Update Posted: Sep 19, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Sol-Gel Technologies, Ltd.: acne vulgaris; acne
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

No Results Posted as of Sep 19, 2019