Acne VulgarisPhase 1NCT04059523
MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3
A Phase 1 study testing S6G5T-3 and Retin-A® 0.1% Cream in people with Acne Vulgaris, run by Sol-Gel Technologies, Ltd. at 2 sites in United States.
Trial summary
To assess the degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults 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 Retin-A® 0.1% Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jun 2019to 6 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male and female subjects 9 years of age or older.
- Subject must consent to participate, verified by signing an approved written Informed Consent Form (ICF).
- Subjects must be generally healthy and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations
- All females of child-bearing potential and premenarchal, excluding women who are surgically sterile
Who cannot join
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne etc.) or severe acne requiring systemic treatment.
- Underlying disease which requires the use of topical or systemic therapy which may confound study results or make results difficult to interpret.;
- Subjects unable to communicate well with the site study team (i.e., language problem, poor mental development or impaired cerebral function).
- Any other factor that, in the opinion of the Investigator, would prevent the subject from complying with the requirements of the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
DermResearch, Inc.
Austin, Texas, 78759
J&S Studies, Inc
College Station, Texas, 77845
About this study
Official title: A Phase 1b, Multicenter, Open-Label, Parallel-Group, Maximal Use Systemic Exposure (MUSE) Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3 Compared to Retin-A® 0.1% in Subjects With Moderate to Severe Acne Vulgaris
To assess the degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults with acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- S6G5T-3, Retin-A® 0.1% Cream
- 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
once daily
Retin-A® 0.1% CreamDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| S6G5T-3 | Experimental | topical cream Receives: Drug: S6G5T-3 |
| Retin-A® 0.1% Cream | Active comparator | topical cream Receives: Drug: Retin-A® 0.1% Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration
The degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) when applied topically once daily for 14 days, under maximal use conditions in subjects with acne vulgaris. Cmax = Maximum plasma concentration will be calculated
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start27 Jun 2019
- Primary completion6 Feb 2020
- Study completion6 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sol-Gel Technologies, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059523
- Sponsor's protocol ID
- SGT-65-03
- Status last verified
- Mar 2020
- First submitted
- 1 Aug 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multicenter, Open-Label, Parallel-Group, Maximal Use Systemic Exposure (MUSE) Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3 Compared to Retin-A® 0.1% in Subjects With Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT04059523
- Acronym / sponsor ID
- SGT-65-03
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sol-Gel Technologies, Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
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 degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults with acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S6G5T-3 | Experimental | Drug: S6G5T-3topical cream |
| Retin-A® 0.1% Cream | Active comparator | Drug: Retin-A® 0.1% Creamtopical cream |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects 9 years of age or older.
- Subject must consent to participate, verified by signing an approved written Informed Consent Form (ICF).
- Subjects must be generally healthy and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations
- All females of child-bearing potential and premenarchal, excluding women who are surgically sterile
Key exclusion criteria (4 listed)
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne etc.) or severe acne requiring systemic treatment.
- Underlying disease which requires the use of topical or systemic therapy which may confound study results or make results difficult to interpret.;
- Subjects unable to communicate well with the site study team (i.e., language problem, poor mental development or impaired cerebral function).
- Any other factor that, in the opinion of the Investigator, would prevent the subject from complying with the requirements of the protocol.
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-3once daily | Drug | S6G5T-3 |
| Retin-A® 0.1% Creamonce daily | Drug | Retin-A® 0.1% Cream |
Primary outcome
Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration
Time frame: 14 days
The degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) when applied topically once daily for 14 days, under maximal use conditions in subjects with acne vulgaris. Cmax = Maximum plasma concentration will be calculated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S6G5T-3 and Retin-A® 0.1% Cream in people with Acne Vulgaris, run by Sol-Gel Technologies, Ltd. at 2 sites 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 4 inclusion and 4 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2020.