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

NCT02661958 | Completed Phase 2

• 1 other identifier: SGT-65-02
• Study Type: interventional
• Target: 726
• Locations: 1 country
• Sites: 34

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.

Conditions

Acne Vulgaris

Keywords

acne vulgaris; acne

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Percentage change from Baseline in lesion count on the face at Week 12

  Baseline and week 12

• assessments of IGA at each time point

  baseline, week 4, 8

Study Arms (6)

S6G5T-3

EXPERIMENTAL

topical cream

Drug: S6G5T-3

S6G5T-1

EXPERIMENTAL

topical cream

Drug: S6G5T-1

S6G5T-5

ACTIVE COMPARATOR

topical cream

Drug: S6G5T-5

S6G5T-7

ACTIVE COMPARATOR

topical cream

Drug: S6G5T-7

S6G5T-6

ACTIVE COMPARATOR

topical cream

Drug: S6G5T-6

S6G5T-8

PLACEBO COMPARATOR

topical cream

Drug: S6G5T-8

Interventions

S6G5T-3 DRUG

once a day topical cream

S6G5T-3

S6G5T-1 DRUG

once a day topical cream

S6G5T-1

S6G5T-5 DRUG

once a day topical cream

S6G5T-5

S6G5T-6 DRUG

once a day topical cream

S6G5T-6

S6G5T-7 DRUG

once a day topical cream

S6G5T-7

S6G5T-8 DRUG

once a day topical cream

S6G5T-8

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 9 years of age or older.
• In good general health Based on medical records
• Have a diagnosis of facial acne with \>25 and \<100 non-inflammatory lesions and \>20 and \<50 inflammatory lesions.
• Have a score of "3" or "4" (Moderate or Severe) on the IGA scale.
• Have two or fewer cysts or nodules (defined as an inflammatory lesion greater than or equal to 5 mm in diameter).
• 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,
• 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
• 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).
• Male subjects must be clean-shaven and agree to remain so for during the study visits.
• 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.

You may not qualify if:

• More than two acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 mm in diameter)
• Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc or severe acne requiring systemic treatment.
• Underlying disease that requires the use of interfering topical or systemic therapy.
• 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.
• Beard, facial hair, or tattoo that may interfere with study assessments.
• Use of tanning booths or tanning lamps within one week prior to Baseline and an unwillingness to refrain from use during the study.
• Use of hormonal contraceptives, unless subject is on a stable dose for at least three months prior to enrollment.
• Use of hormonal contraceptives solely for the control of acne.
• Use of prohibited medications prior to the study and unwillingness to refrain from use during the study.
• Known sensitivities to the study drug ingredients. Allergy to benzoyl peroxide, tretinoin, parabens and glycerin or other ingredients listed in the investigator brochure.
• 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.
• 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.
• Participation in another investigational drug or device research study within 30 days of enrollment or five half-lives of the drug, whichever is longer.
• Current or history of facial skin cancer.
• Is an employee or family member of the study investigator or other study staff having direct involvement in the proposed study.

Sponsors & Collaborators

• Sol-Gel Technologies, Ltd.: lead
• Accelovance: collaborator

Study Sites (34)

Orange County Research Institute

Anaheim, California, 92801, United States

Location

Core Healthcare Group

Cerritos, California, 90703, United States

Location

eStudySite

Chula Vista, California, 91911, United States

Location

T. Joseph Raoof MD, Inc./Encino Research Center

Encino, California, 91436, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

eStudySite

Oceanside, California, 92056, United States

Location

Empire Clinical Research

Upland, California, 91786, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

MOORE Clinical Research, Inc

Brandon, Florida, 33511, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

LCC Medical Research Institute, LLC

Miami, Florida, 33126, United States

Location

Oceane7 Clinical Research

Miami, Florida, 33144, United States

Location

RM Medical Research, LLC

Miami, Florida, 33175, United States

Location

IMIC Inc.

Palmetto Bay, Florida, 33157, United States

Location

Clinical Research Trials of Florida, Inc.

Tampa, Florida, 33607, United States

Location

Meridien Research

Tampa, Florida, 33634, United States

Location

Heartland Research Associates, LLC

Augusta, Kansas, 67010, United States

Location

Dermatology Specialists Research

Louisville, Kentucky, 40202, United States

Location

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

MediSearch clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Quality Clinical Research Inc.

Omaha, Nebraska, 68114, United States

Location

eStudySite

Las Vegas, Nevada, 89109, United States

Location

ActivMed Practices and Research, Inc.

Portsmouth, New Hampshire, 3801, United States

Location

New York Clinical Trials

Manhattan, New York, 10018, United States

Location

Derm Research Center of New York, Inc

Stony Brook, New York, 11790, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Paddington Testing Co, Inc

Philadelphia, Pennsylvania, 19103, United States

Location

Palmetto Clinical Trial Services, LLC @ Greenville Dermatology

Greenville, South Carolina, 29607, United States

Location

Discover Research, Inc.

Bryan, Texas, 77802, United States

Location

West Houston Clinical Research Services LLC

Houston, Texas, 77055, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Piyush Sheladia, M.S.

  Accelovance

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 25, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

US (34)