TSN2898-201 Safety and Efficacy of TSN2898 in the Treatment of Acne Vulgaris

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02796066

Enrollment

Registered

2016-06-10

Start date

2016-06-30

Completion date

2017-02-28

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

Acne, topical, SCD-1 inhibitor, moderate, severe

Brief 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.

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.

Interventions

DRUGVehicle

Applied once a day

DRUGTSN2898

Applied once a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	12 weeks

Secondary

Measure	Time frame	Description
Non-inflammatory lesion counts	12 weeks	Absolute change from Baseline
Absolute change from Baseline for inflammatory plus non-inflammatory lesions	12 weeks	—
Percent change from Baseline for inflammatory and non-inflammatory lesions	12 weeks	—
Investigator's Global Assessment of Acne Severity Score (IGA)	12 weeks	—

Countries

Dominican Republic, Honduras, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026