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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02796066
• Other study ID #: TSN2898-201
• Status: Withdrawn
• Phase: Phase 2
• First received: May 26, 2016
• Last updated: April 24, 2017
• Start date: June 2016
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: Thesan Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

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, a-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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Vehicle
Applied once a day
• TSN2898
Applied once a day
• TSN2898
Applied once a day
• TSN2898
Applied once a day

Locations

Country	Name	City	State
Dominican Republic	Thesan Site 2	Santo Domingo
Honduras	Thesan Site 1	San Pedro Sula
United States	Thesan Site 6	High Point	North Carolina
United States	Thesan Site 5	Johnston	Rhode Island
United States	Thesan Site 3	Miami	Florida
United States	Thesan Site 4	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Thesan Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Dominican Republic,  Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)		12 weeks
Secondary	Non-inflammatory lesion counts	Absolute change from Baseline	12 weeks
Secondary	Absolute change from Baseline for inflammatory plus non-inflammatory lesions		12 weeks
Secondary	Percent change from Baseline for inflammatory and non-inflammatory lesions		12 weeks
Secondary	Investigator's Global Assessment of Acne Severity Score (IGA)		12 weeks