A Phase 2 interventional study of S6G5T-3 and S6G5T-1 in Acne Vulgaris, sponsored by Sol-Gel Technologies, Ltd.. Completed at 34 sites in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by Sol-Gel Technologies, Ltd. · Phase 2, Interventional, and Treatment
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 726 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Sol-Gel Technologies, Ltd. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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,
Exclusion Criteria:
topical cream
Drug: S6G5T-3
topical cream
Drug: S6G5T-1
topical cream
Drug: S6G5T-5
topical cream
Drug: S6G5T-7
topical cream
Drug: S6G5T-6
topical cream
Drug: S6G5T-8
once a day topical cream
once a day topical cream
once a day topical cream
once a day topical cream
once a day topical cream
once a day topical cream
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
Time frame: 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)
Time frame: baseline and week 12
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)
Time frame: Baseline and week 12
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.
Time frame: baseline, week 4, 8
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sol-Gel Technologies, Ltd.