Acne VulgarisPhase 2NCT02661958
Efficacy, Safety, and Tolerability of S6G5T-1 and S6G5T-3 for the Treatment of Acne Vulgaris
A Phase 2 study testing S6G5T-3, S6G5T-1 and S6G5T-5 in people with Acne Vulgaris, run by Sol-Gel Technologies, Ltd. at 34 sites in United States.
Trial 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. 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, S6G5T-1 and S6G5T-5
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 726 participants
- Where
- 34 sitesUnited States
- Study dates
- May 2016to Oct 2017
- Phase
- Phase 2
- 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.
- 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:
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- One of these highly effective contraception methods:
- 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).
- Male subjects must be clean-shaven and agree to remain so for during the study visits.
- Consent to participate, verified by signing an approved written Informed Consent Form and HIPAA; for subjects under the age of consent, both a signed assent form and a signed Informed Consent Form from the parent/guardian are required in accordance with local and federal regulations.
Who cannot join
- 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.
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- 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.
- Clinically significant abnormal findings or conditions (other than acne), which might, in the opinion of the investigator, interfere with study evaluations or pose a risk to subject safety during the study.
- Female subjects who are pregnant and/or nursing or planning to become pregnant during the course of the trial. Subjects who test positive for pregnancy after start of test treatment will be discontinued from test treatment but will be followed for safety purposes.
- Participation in another investigational drug or device research study within 30 days of enrollment or five half-lives of the drug, whichever is longer.
- Current or history of facial skin cancer.
- Is an employee or family member of the study investigator or other study staff having direct involvement in the proposed study.
- Is a family member of a study participant recruited and enrolled into the proposed study.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Orange County Research Institute
Anaheim, California, 92801
Heartland Research Associates, LLC
Augusta, Kansas, 67010
MOORE Clinical Research, Inc
Brandon, Florida, 33511
Discover Research, Inc.
Bryan, Texas, 77802
Core Healthcare Group
Cerritos, California, 90703
eStudySite
Chula Vista, California, 91911
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, 91436
Palmetto Clinical Trial Services, LLC @ Greenville Dermatology
Greenville, South Carolina, 29607
Dermatology Consulting Services
High Point, North Carolina, 27262
West Houston Clinical Research Services LLC
Houston, Texas, 77055
Health Awareness, Inc.
Jupiter, Florida, 33458
eStudySite
Las Vegas, Nevada, 89109
Dermatology Research Associates
Los Angeles, California, 90045
Dermatology Specialists Research
Louisville, Kentucky, 40202
DermResearch, PLLC
Louisville, Kentucky, 40217
New York Clinical Trials
Manhattan, New York, 10018
LCC Medical Research Institute, LLC
Miami, Florida, 33126
Oceane7 Clinical Research
Miami, Florida, 33144
RM Medical Research, LLC
Miami, Florida, 33175
DelRicht Research
New Orleans, Louisiana, 70115
eStudySite
Oceanside, California, 92056
Quality Clinical Research Inc.
Omaha, Nebraska, 68114
IMIC Inc.
Palmetto Bay, Florida, 33157
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, 19103
ActivMed Practices and Research, Inc.
Portsmouth, New Hampshire, 3801
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
MediSearch clinical Trials
Saint Joseph, Missouri, 64506
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Derm Research Center of New York, Inc
Stony Brook, New York, 11790
Clinical Research Trials of Florida, Inc.
Tampa, Florida, 33607
Meridien Research
Tampa, Florida, 33634
Empire Clinical Research
Upland, California, 91786
About this study
Official title: 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
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.
- Conditions
- Acne Vulgaris
- Being tested
- S6G5T-3, S6G5T-1, S6G5T-5, S6G5T-6, S6G5T-7
- Keywords
- acne vulgaris, acne
- 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 a day topical cream
S6G5T-1Drug
once a day topical cream
S6G5T-5Drug
once a day topical cream
S6G5T-6Drug
once a day topical cream
S6G5T-7Drug
once a day topical cream
S6G5T-8Drug
once a day topical cream
| Study group | Role | What they receive |
|---|---|---|
| S6G5T-3 | Experimental | topical cream Receives: Drug: S6G5T-3 |
| S6G5T-1 | Experimental | topical cream Receives: Drug: S6G5T-1 |
| S6G5T-5 | Active comparator | topical cream Receives: Drug: S6G5T-5 |
| S6G5T-7 | Active comparator | topical cream Receives: Drug: S6G5T-7 |
| S6G5T-6 | Active comparator | topical cream Receives: Drug: S6G5T-6 |
| S6G5T-8 | Placebo comparator | topical cream Receives: Drug: S6G5T-8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: baseline and week 12
Secondary outcomes (2)
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)
Measured: 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.
Measured: baseline, week 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2017
- Study completionOct 2017
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 726 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sol-Gel Technologies, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accelovance
- Responsible party
- Sponsor
- Investigators
- Piyush Sheladia, M.S., Study chair, Accelovance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661958
- Sponsor's protocol ID
- SGT-65-02
- Status last verified
- Sep 2019
- First submitted
- 11 Jan 2016
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02661958
- Acronym / sponsor ID
- SGT-65-02
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, acne
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 726 participants (actual)
- Lead sponsor
- Sol-Gel Technologies, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Accelovance
- Study start
- May 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 25 Jan 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| S6G5T-3 | Experimental | Drug: S6G5T-3topical cream |
| S6G5T-1 | Experimental | Drug: S6G5T-1topical cream |
| S6G5T-5 | Active comparator | Drug: S6G5T-5topical cream |
| S6G5T-7 | Active comparator | Drug: S6G5T-7topical cream |
| S6G5T-6 | Active comparator | Drug: S6G5T-6topical cream |
| S6G5T-8 | Placebo comparator | Drug: S6G5T-8topical cream |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
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 a day topical cream | Drug | S6G5T-3 |
| S6G5T-1once a day topical cream | Drug | S6G5T-1 |
| S6G5T-5once a day topical cream | Drug | S6G5T-5 |
| S6G5T-6once a day topical cream | Drug | S6G5T-6 |
| S6G5T-7once a day topical cream | Drug | S6G5T-7 |
| S6G5T-8once a day topical cream | Drug | S6G5T-8 |
Primary outcome
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
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)
2 secondary outcomes
Percentage change from Baseline in lesion count on the face at Week 12
Time frame: Baseline and week 12
assessments of IGA at each time point
Time frame: baseline, week 4, 8
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 19 Sep 2019.
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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.
Piyush Sheladia, M.S. study chair
Accelovance
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S6G5T-3, S6G5T-1 and S6G5T-5 in people with Acne Vulgaris, run by Sol-Gel Technologies, Ltd. at 34 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 12 inclusion and 16 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 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Investigator's Global Assessment (IGA) (time frame: week 12). The study lists 2 primary outcomes in all. 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 19 Sep 2019.