Clinical trial NCT02661958: Efficacy, Safety, and Tolerability of S6G5T-1 and S6G5T-3 for the Treatment of Acne Vulgaris
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: acne vulgaris
acne
Lead sponsor: Sol-Gel Technologies, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Accelovance
First posted: 2016-01-25
Enrollment: 726
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Investigator's Global Assessment (IGA)
timeFrame: week 12
measure: Absolute change in lesion count (separately for inflammatory and non-inflammatory)
timeFrame: baseline and week 12
Secondary outcomes:
measure: Percentage change from Baseline in lesion count on the face at Week 12
timeFrame: Baseline and week 12
measure: assessments of IGA at each time point
timeFrame: baseline, week 4, 8
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: Encino
country: United States
facility: T. Joseph Raoof MD, Inc./Encino Research Center
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Oceanside
country: United States
facility: eStudySite
state: California
city: Upland
country: United States
facility: Empire Clinical Research
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Brandon
country: United States
facility: MOORE Clinical Research, Inc
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Oceane7 Clinical Research
state: Florida
city: Miami
country: United States
facility: RM Medical Research, LLC
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC Inc.
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Saint Joseph
country: United States
facility: MediSearch clinical Trials
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: eStudySite
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices and Research, Inc.
state: New Hampshire
city: Manhattan
country: United States
facility: New York Clinical Trials
state: New York
city: Stony Brook
country: United States
facility: Derm Research Center of New York, Inc
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Philadelphia
country: United States
facility: Paddington Testing Co, Inc
state: Pennsylvania
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services, LLC @ Greenville Dermatology
state: South Carolina
city: Bryan
country: United States
facility: Discover Research, Inc.
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Services LLC
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
Study officials:
affiliation: Accelovance
name: Piyush Sheladia, M.S.
role: STUDY_CHAIR
References: