Clinical Trials/NCT02661958

NCT02661958

Completed

Phase 2

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

Sol-Gel Technologies, Ltd.32 sites in 1 country726 target enrollmentMay 2016

ConditionsAcne Vulgaris

InterventionsS6G5T-7 S6G5T-3 S6G5T-1 S6G5T-5 S6G5T-6 S6G5T-8

Overview

Phase: Phase 2
Intervention: S6G5T-7
Conditions: Acne Vulgaris
Sponsor: Sol-Gel Technologies, Ltd.
Enrollment: 726
Locations: 32
Primary Endpoint: Absolute change in lesion count (separately for inflammatory and non-inflammatory)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

October 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sol-Gel Technologies, Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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).

Exclusion Criteria

•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.

Arms & Interventions

S6G5T-7

topical cream

Intervention: S6G5T-7

S6G5T-3

topical cream

Intervention: S6G5T-3

S6G5T-1

topical cream

Intervention: S6G5T-1

S6G5T-5

topical cream

Intervention: S6G5T-5

S6G5T-6

topical cream

Intervention: S6G5T-6

S6G5T-8

topical cream

Intervention: S6G5T-8

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

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)