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

T

Thesan Pharmaceuticals

Status and phase

Withdrawn
Phase 2

Conditions

Acne Vulgaris

Treatments

Drug: TSN2898
Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT02796066
TSN2898-201

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

16 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 4 patient groups, including a placebo group

Vehicle
Placebo Comparator group
Description:
Vehicle gel
Treatment:
Drug: Vehicle
Low Dose Active
Experimental group
Description:
Low Dose of TSN2898
Treatment:
Drug: TSN2898
Mid Dose Active
Experimental group
Description:
Mid Dose of TSN2898
Treatment:
Drug: TSN2898
High Dose Active
Experimental group
Description:
High Dose of TSN2898
Treatment:
Drug: TSN2898

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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