Acne VulgarisPhase 3NCT03761784

A Study of S6G5T-3 in the Treatment of Acne Vulgaris

A Phase 3 study testing S6G5T-3 and S6G5T-8 in people with Acne Vulgaris, run by Sol-Gel Technologies, Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 9 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: S6G5T-3 and S6G5T-8
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 424 participants
Where: 1 siteUnited States
Study dates: 21 Dec 2018to 31 Dec 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dermatology Consulting Services
High Point, North Carolina, 27262

Other trials in United States

About this study

Official title: A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris

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: Acne Vulgaris
Being tested: S6G5T-3, S6G5T-8
Keywords: Acne Vulgaris
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

S6G5T-3Drug
Also called Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream)
Once a day topical cream
S6G5T-8Drug
Also called Vehicle
Once a day topical cream

Study groups in NCT03761784
Study group	Role	What they receive
S6G5T-3	Experimental	Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks. Receives: Drug: S6G5T-3
S6G5T-8 Vehicle Cream	Placebo comparator	Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks. Receives: Drug: S6G5T-8

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Measured: 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.
Measured: Baseline, Week 12

Secondary outcomes (8)

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.
Measured: 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Measured: 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 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").
Measured: 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").
Measured: 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.
Measured: 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Measured: 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.
Measured: 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Measured: Baseline, Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 201831 Dec 2019

First posted3 Dec 2018
Study start21 Dec 2018
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 424 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03761784
Sponsor's protocol ID: SGT-65-04
Status last verified: Dec 2021
First submitted: 30 Nov 2018
Last updated: 16 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris
ClinicalTrials.gov ID: NCT03761784
Acronym / sponsor ID: SGT-65-04
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 424 participants (actual)
Lead sponsor: Sol-Gel Technologies, Ltd.Industry (pharma, biotech, devices)
Study start: 21 Dec 2018 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 3 Dec 2018 (actual)
Results: Posted 1 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

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

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
S6G5T-3Also: Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream)Once a day topical cream	Drug	S6G5T-3
S6G5T-8Also: VehicleOnce a day topical cream	Drug	S6G5T-8 Vehicle Cream

Primary outcome

Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
Time frame: Baseline through Week 12
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.
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
Time frame: Baseline, 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Time frame: Baseline, 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.

8 secondary outcomes

Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
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)
Time frame: Baseline and Week 12
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
Time frame: Baseline and Week 12
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4
Time frame: Baseline, Week 4

Results and safety

Results posted to the registry on 1 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
S6G5T-3	281	249
S6G5T-8 Vehicle Cream	143	131

Primary outcome: Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline

Time frame: Baseline through Week 12. Number. Unit: percentage of participants

Measure	S6G5T-3 n = 281	S6G5T-8 Vehicle Cream n = 143
Value	38.5	11.5

Population analysed: The ITT population consisted of all randomized participants who were dispensed study drug. Multiple imputation (MCMC) was used to impute missing values.

Primary outcome: Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12

Time frame: Baseline, Week 12. Least squares mean (Standard Deviation). Unit: Inflammatory Lesions

Measure	S6G5T-3 n = 281	S6G5T-8 Vehicle Cream n = 143
Value	-21.6 (10.67)	-14.8 (11.03)

Population analysed: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.

Primary outcome: Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12

Time frame: Baseline, Week 12. Least squares mean (Standard Deviation). Unit: Non-Inflammatory Lesions

Measure	S6G5T-3 n = 281	S6G5T-8 Vehicle Cream n = 143
Value	-29.7 (15.26)	-19.8 (15.84)

Population analysed: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (Day 0) through end of study (Week 12). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
S6G5T-3	0 of 274 (0%)	69 of 274 (25.2%)	0 of 274
S6G5T-8 Vehicle Cream	0 of 139 (0%)	8 of 139 (5.8%)	0 of 139

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing S6G5T-3 and S6G5T-8 in people with Acne Vulgaris, run by Sol-Gel Technologies, Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline (time frame: Baseline through Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03761784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.