CompletedNCT03761810Updated Dec 16, 2021Results posted

A Study of S6G5T3 in the Treatment of Acne Vulgaris

A Phase 3 interventional study of S6G5T-3 and S6G5T-8 in Acne Vulgaris, sponsored by Sol-Gel Technologies, Ltd.. Completed at 1 site in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2021-12-16.

Sponsored by Sol-Gel Technologies, Ltd. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 434
Allocation: Randomized
Ages: 9 Years and older
Sex: All

Study summary

To assess the efficacy of S6G5T-3 compared to its vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

Read the detailed description

In this Phase 3, multi-center, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 9 years of age with facial acne vulgaris will be eligible for enrollment for daily treatment with S6G5T-3 or its vehicle S6G5T-8, for 12 weeks.

Conditions studied

Acne Vulgaris

Browse trials for

Acne Vulgaris 790

In context

Acne Vulgaris

790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.

This study's enrollment of 434 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

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.

Who can participate

Ages eligible: 9 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participant must sign an Institutional Review Board (IRB) approved written for this study.
Male and female 9 years of age and older.
Have 2 or fewer cysts or nodules.

Exclusion criteria

Exclusion Criteria:

More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter [mm] in diameter).
Acne conglobata, acne fulminans and secondary acne (for example, chloracne, drug-induced acne).
History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma).
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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 434 participants (actual)

Study arms

Experimental
S6G5T-3
Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks
Drug: S6G5T-3
Placebo comparator
S6G5T-8 Vehicle Cream
Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Drug: S6G5T-8

Interventions

DrugS6G5T-3
Once a day topical cream
Also known as: Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream)
DrugS6G5T-8
Once a day topical cream
Also known as: Vehicle

What researchers measure

Primary outcomes

Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.
Time frame: Baseline through Week 12
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Time frame: Baseline, Week 12
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Time frame: Baseline, Week 12

Secondary outcomes

Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Time frame: Baseline, Week 12
Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Time frame: Baseline, Week 12
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
Percent of participants in each treatment group achieving at least a 4 point reduction on Item 1 (Pimple) of the patient- reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 ("no pimples at all") to 10 ("pimples as bad as you can imagine").
Time frame: Baseline and Week 12
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
Percent of participants in each treatment group achieving at least a 4 point reduction on Item 5 (Embarrassment) of the patient reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst, in the 24 hours prior to administration on an 11-point NRS ranging from 0 ("not embarrassed at all") to 10 ("extremely embarrassed").
Time frame: Baseline and Week 12
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8
Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Time frame: Baseline, Week 8
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8
Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Time frame: Baseline, Week 8
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4
Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Time frame: Baseline, Week 4
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4
Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Time frame: Baseline, Week 4

Results

Posted Dec 1, 2021

Participant flow

Participant flow — Overall Study
Milestone	S6G5T-3	S6G5T-8 Vehicle Cream
Started	290	144
Received at least 1 dose of study drug	281	138
Completed	242	132
Not completed	48	12
Withdrew: Adverse event	12	0
Withdrew: Lost to follow-up	15	7
Withdrew: Pregnancy	1	0
Withdrew: Withdrawal by subject	14	5
Withdrew: Physician decision	1	0
Withdrew: Withdrawal by parent/guardian	4	0
Withdrew: Other than specified	1	0

Outcome measures

PrimaryPercentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline

Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.

Time frame:: Baseline through Week 12
Reported as:: Number · percentage of participants

Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
percentage of participants	S6G5T-3	S6G5T-8 Vehicle Cream
Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline	25.4	14.7

PrimaryChange From Baseline in Inflammatory Lesion Counts on the Face at Week 12

Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · Inflammatory Lesions

Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
Inflammatory Lesions	S6G5T-3	S6G5T-8 Vehicle Cream
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12	-16.2 ± 9.07	-14.1 ± 8.68

PrimaryChange From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12

Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · Non-Inflammatory Lesions

Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Non-Inflammatory Lesions	S6G5T-3	S6G5T-8 Vehicle Cream
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12	-24.2 ± 15.82	-17.4 ± 15.82

SecondaryPercent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Percent Change	S6G5T-3	S6G5T-8 Vehicle Cream
Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12	-54.4 ± 32.28	-41.5 ± 33.44

SecondaryPercent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12

Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
Percent Change	S6G5T-3	S6G5T-8 Vehicle Cream
Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12	-57.6 ± 32.41	-50.8 ± 31.17

SecondaryPercentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)

Percent of participants in each treatment group achieving at least a 4 point reduction on Item 1 (Pimple) of the patient- reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 ("no pimples at all") to 10 ("pimples as bad as you can imagine").

Time frame:: Baseline and Week 12
Reported as:: Number · Percentage of Participants

Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
Percentage of Participants	S6G5T-3	S6G5T-8 Vehicle Cream
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)	35.1	27.2

SecondaryPercentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face

Percent of participants in each treatment group achieving at least a 4 point reduction on Item 5 (Embarrassment) of the patient reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst, in the 24 hours prior to administration on an 11-point NRS ranging from 0 ("not embarrassed at all") to 10 ("extremely embarrassed").

Time frame:: Baseline and Week 12
Reported as:: Number · Percentage of Participants

Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
Percentage of Participants	S6G5T-3	S6G5T-8 Vehicle Cream
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face	33.9	37.1

SecondaryChange From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8

Time frame:: Baseline, Week 8
Reported as:: Least squares mean · Non-Inflammatory Lesions

Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8
Non-Inflammatory Lesions	S6G5T-3	S6G5T-8 Vehicle Cream
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8	-20.0 ± 16.43	-12.8 ± 16.21

SecondaryChange From Baseline in Inflammatory Lesion Counts on the Face at Week 8

Time frame:: Baseline, Week 8
Reported as:: Least squares mean · Inflammatory Lesions

Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8
Inflammatory Lesions	S6G5T-3	S6G5T-8 Vehicle Cream
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8	-14.0 ± 8.57	-12.5 ± 8.57

SecondaryChange From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4

Time frame:: Baseline, Week 4
Reported as:: Least squares mean · Non-Inflammatory Lesions

Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4
Non-Inflammatory Lesions	S6G5T-3	S6G5T-8 Vehicle Cream
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4	-14.6 ± 14.51	-10.8 ± 14.88

SecondaryChange From Baseline in Inflammatory Lesion Counts on the Face at Week 4

Time frame:: Baseline, Week 4
Reported as:: Least squares mean · Inflammatory Lesions

Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4
Inflammatory Lesions	S6G5T-3	S6G5T-8 Vehicle Cream
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4	-10.7 ± 7.94	-10.1 ± 7.81

Adverse events

Collected over Baseline (Day 0) through end of study (Week 12). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
S6G5T-3	0/281 (0%)	1/281 (0.4%)	68/281 (24.2%)
S6G5T-8 Vehicle Cream	0/138 (0%)	1/138 (0.7%)	4/138 (2.9%)

Most frequent serious events

Most frequent serious events
Event	S6G5T-3	S6G5T-8 Vehicle Cream
DepressionPsychiatric disorders	1/281	1/138
Bipolar II disorderPsychiatric disorders	0/281	1/138
Conduct disorderPsychiatric disorders	0/281	1/138

Most frequent other events

Most frequent other events
Event	S6G5T-3	S6G5T-8 Vehicle Cream
Application site painGeneral disorders	27/281	1/138
Application site drynessGeneral disorders	10/281	0/138
Application site exfoliationGastrointestinal disorders	9/281	0/138
Application site erythemaGeneral disorders	8/281	0/138
Application site dermatitisGeneral disorders	5/281	0/138
Application site pruritusGeneral disorders	5/281	0/138
Viral upper respiratory tract infectionInfections and infestations	1/281	2/138
NasopharyngitisInfections and infestations	4/281	0/138
Application site photosensitivityGeneral disorders	3/281	1/138

Baseline characteristics

The intent-to-treat (ITT) population consisted of all randomized participants who were dispensed study drug.

Age, Continuous
Age, Continuous(Years)	S6G5T-3	S6G5T-8 Vehicle Cream	Total
Mean	20.1 ± 6.96	20.3 ± 6.67	20.1 ± 6.86

Sex: Female, Male
Sex: Female, Male(Participants)	S6G5T-3	S6G5T-8 Vehicle Cream	Total
Female	173	77	250
Male	117	67	184

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	S6G5T-3	S6G5T-8 Vehicle Cream	Total
Hispanic or Latino	85	56	141
Not Hispanic or Latino	204	87	291
Unknown or Not Reported	1	1	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	S6G5T-3	S6G5T-8 Vehicle Cream	Total
American Indian or Alaska Native	2	2	4
Asian	12	6	18
Native Hawaiian or Other Pacific Islander	1	1	2
Black or African American	52	18	70
White	212	110	322
More than one race	11	7	18
Unknown or Not Reported	0	0	0

Baseline Acne Lesion Count on the Face
Baseline Acne Lesion Count on the Face(Lesions)	S6G5T-3	S6G5T-8 Vehicle Cream	Total
Inflammatory Lesions	28.2 ± 8.70	27.5 ± 8.52	28.0 ± 8.64
Non-Inflammatory Lesions	44.6 ± 18.03	44.9 ± 18.82	44.7 ± 18.27

Baseline Investigator's Global Assessment (IGA)
Baseline Investigator's Global Assessment (IGA)(Participants)	S6G5T-3	S6G5T-8 Vehicle Cream	Total
0 - Clean	0	0	0
1 - Almost Clear	0	0	0
2 - Mild	0	0	0
3 - Moderate	262	133	395
4 - Severe	28	10	38

Study locations

1 site

Sol-Gel site 501
Tampa, Florida 33607, United States

References and documents

Study documents

Study protocol ↗ · Nov 1, 2018
Statistical analysis plan ↗ · Nov 26, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2018 to primary completion in Oct 2019, 10 months.

Results were first posted in Dec 2021, 2 years 1 month after primary completion.

Of 53 industry-sponsored phase 3 interventional studies under Acne Vulgaris, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 17. This study's 10 months is below that.

Counting every sponsor, half of 62 studies reached it within 13 months; a quarter within 10 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 30, 2018
First posted: Dec 3, 2018
StartActual: Dec 14, 2018
Primary completionActual: Oct 23, 2019
CompletionActual: Oct 23, 2019
Results first posted: Dec 1, 2021
Last update: Dec 16, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03761810
Lead sponsor: Sol-Gel Technologies, Ltd.
Responsible party: Sponsor
First posted: Dec 3, 2018
Start date: Dec 14, 2018
Primary completion: Oct 23, 2019
Completion: Oct 23, 2019
Results posted: Dec 1, 2021
Last update: Dec 16, 2021

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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