Clinical trial NCT02796066: TSN2898-201 Safety and Efficacy of TSN2898 in the Treatment of Acne Vulgaris
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Acne, topical, SCD-1 inhibitor, moderate, severe
Lead sponsor: Thesan Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-10
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: 12 weeks
Secondary outcomes:
measure: Non-inflammatory lesion counts
timeFrame: 12 weeks
measure: Absolute change from Baseline for inflammatory plus non-inflammatory lesions
timeFrame: 12 weeks
measure: Percent change from Baseline for inflammatory and non-inflammatory lesions
timeFrame: 12 weeks
measure: Investigator's Global Assessment of Acne Severity Score (IGA)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Thesan Site 4
state: California
city: Miami
country: United States
facility: Thesan Site 3
state: Florida
city: High Point
country: United States
facility: Thesan Site 6
state: North Carolina
city: Johnston
country: United States
facility: Thesan Site 5
state: Rhode Island
city: Santo Domingo
country: Dominican Republic
facility: Thesan Site 2
city: San Pedro Sula
country: Honduras
facility: Thesan Site 1
Study officials:
affiliation: Thesan Pharmaceuticals
name: Howard Welgus, MD
role: STUDY_DIRECTOR
References: