Acne VulgarisPhase 2NCT02796066
TSN2898-201 Safety and Efficacy of TSN2898 in the Treatment of Acne Vulgaris
A Phase 2 study testing TSN2898 in people with Acne Vulgaris, run by Thesan Pharmaceuticals, Inc. at 6 sites in 3 countries.
Trial summary
The purpose of this study is to determine the safety and effectiveness of TSN 2898 topical gel in the treatment of moderate to severe acne. Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- TSN2898
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jun 2016to Feb 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 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy males or females, 16 to 55 years of age
- Must be diagnosed as having moderate or severe acne vulgaris
- ≥ 20 inflammatory lesions on the face
- ≥ 20 non-inflammatory lesions on the face
- ≤ 3 nodule/cyst acne lesions
- Medically healthy
- Females must be of non-childbearing potential
Who cannot join
- Systemic therapy with retinoids within six (6) months prior to study start
- Topical use of prescription retinoids within four (4) weeks prior to study start
- Oral antibiotics within four (4) weeks prior to study start
- Topical dapsone, sulfacetamide, benzoyl peroxide, α-hydroxy/glycolic acid and retinol/retinaldehyde-containing products, and topical antibiotics, anti-inflammatory medications and corticosteroids on the face within two (2) weeks prior to study start
- Facial procedures, including lasers, peels, and dermabrasion, within two (2) months prior to study start
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Thesan Site 6
High Point, North Carolina, 27626
Thesan Site 5
Johnston, Rhode Island, 02919
Thesan Site 3
Miami, Florida, 33144
Thesan Site 4
San Diego, California, 92123
About this study
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of TSN2898 Topical Gel for the Treatment of Acne Vulgaris
The purpose of this study is to determine the safety and effectiveness of TSN 2898 topical gel in the treatment of moderate to severe acne.
Read the detailed description
TSN2898 is an inhibitor of stearoyl-CoA desaturase-1 (SCD-1), an enzyme present in sebaceous glands and a key regulatory enzyme in lipogenesis. This study will assess the safety and efficacy of TSN2898 topical gel and matched gel vehicle, applied daily on the face for the treatment of moderate to severe acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Vehicle, TSN2898
- Keywords
- Acne, topical, SCD-1 inhibitor, moderate, severe
- Medical subject headings
- Acne Vulgaris, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VehicleDrug
Also called Topical gel
Applied once a day
TSN2898Drug
Also called Topical gel
Applied once a day
TSN2898Drug
Also called Topical gel
Applied once a day
TSN2898Drug
Also called Topical gel
Applied once a day
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle gel Receives: Drug: Vehicle |
| Low Dose Active | Experimental | Low Dose of TSN2898 Receives: Drug: TSN2898 |
| Mid Dose Active | Experimental | Mid Dose of TSN2898 Receives: Drug: TSN2898 |
| High Dose Active | Experimental | High Dose of TSN2898 Receives: Drug: TSN2898 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Measured: 12 weeks
Secondary outcomes (4)
Non-inflammatory lesion counts
Absolute change from Baseline
Measured: 12 weeks
Absolute change from Baseline for inflammatory plus non-inflammatory lesions
Measured: 12 weeks
Percent change from Baseline for inflammatory and non-inflammatory lesions
Measured: 12 weeks
Investigator's Global Assessment of Acne Severity Score (IGA)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: Protocol not approved
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thesan Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Welgus, MD, Study director, Thesan Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796066
- Sponsor's protocol ID
- TSN2898-201
- Status last verified
- Apr 2017
- First submitted
- 26 May 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of TSN2898 Topical Gel for the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02796066
- Acronym / sponsor ID
- TSN2898-201
- Conditions
- Acne Vulgaris
- Keywords
- Acne, topical, SCD-1 inhibitor, moderate, severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol not approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thesan Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 10 Jun 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 determine the safety and effectiveness of TSN 2898 topical gel in the treatment of moderate to severe acne.
Detailed description
TSN2898 is an inhibitor of stearoyl-CoA desaturase-1 (SCD-1), an enzyme present in sebaceous glands and a key regulatory enzyme in lipogenesis. This study will assess the safety and efficacy of TSN2898 topical gel and matched gel vehicle, applied daily on the face for the treatment of moderate to severe acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: VehicleVehicle gel |
| Low Dose Active | Experimental | Drug: TSN2898Low Dose of TSN2898 |
| Mid Dose Active | Experimental | Drug: TSN2898Mid Dose of TSN2898 |
| High Dose Active | Experimental | Drug: TSN2898High Dose of TSN2898 |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Healthy males or females, 16 to 55 years of age
- Must be diagnosed as having moderate or severe acne vulgaris
- ≥ 20 inflammatory lesions on the face
- ≥ 20 non-inflammatory lesions on the face
- ≤ 3 nodule/cyst acne lesions
Key exclusion criteria (5 listed)
- Systemic therapy with retinoids within six (6) months prior to study start
- Topical use of prescription retinoids within four (4) weeks prior to study start
- Oral antibiotics within four (4) weeks prior to study start
- Topical dapsone, sulfacetamide, benzoyl peroxide, α-hydroxy/glycolic acid and retinol/retinaldehyde-containing products, and topical antibiotics, anti-inflammatory medications and corticosteroids on the face within two (2) weeks prior to study start
- Facial procedures, including lasers, peels, and dermabrasion, within two (2) months prior to study start
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 |
|---|---|---|
| VehicleAlso: Topical gelApplied once a day | Drug | Vehicle |
| TSN2898Also: Topical gelApplied once a day | Drug | Low Dose Active |
| TSN2898Also: Topical gelApplied once a day | Drug | Mid Dose Active |
| TSN2898Also: Topical gelApplied once a day | Drug | High Dose Active |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: 12 weeks
4 secondary outcomes
Non-inflammatory lesion counts
Time frame: 12 weeks
Absolute change from Baseline for inflammatory plus non-inflammatory lesions
Time frame: 12 weeks
Percent change from Baseline for inflammatory and non-inflammatory lesions
Time frame: 12 weeks
Investigator's Global Assessment of Acne Severity Score (IGA)
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- 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.
Howard Welgus, MD study director
Thesan Pharmaceuticals
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TSN2898 in people with Acne Vulgaris, run by Thesan Pharmaceuticals, Inc. at 6 sites in 3 countries.
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 7 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: withdrawn, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Dominican Republic, Honduras. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: 12 weeks). 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 26 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.