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

NCT02796066 | Withdrawn Phase 2

• 1 other identifier: TSN2898-201
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 6

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.

Conditions

Acne Vulgaris

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  12 weeks

Secondary Outcomes (4)

• Non-inflammatory lesion counts

  12 weeks

• 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

Study Arms (4)

Vehicle

PLACEBO COMPARATOR

Vehicle gel

Drug: Vehicle

Low Dose Active

EXPERIMENTAL

Low Dose of TSN2898

Drug: TSN2898

Mid Dose Active

EXPERIMENTAL

Mid Dose of TSN2898

Drug: TSN2898

High Dose Active

EXPERIMENTAL

High Dose of TSN2898

Drug: TSN2898

Interventions

Vehicle DRUG

Applied once a day

Also known as: Topical gel

Vehicle

TSN2898 DRUG

Applied once a day

Also known as: Topical gel

Low Dose Active

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thesan Pharmaceuticals, Inc.: lead

Study Sites (6)

Thesan Site 4

San Diego, California, 92123, United States

Location

Thesan Site 3

Miami, Florida, 33144, United States

Location

Thesan Site 6

High Point, North Carolina, 27626, United States

Location

Thesan Site 5

Johnston, Rhode Island, 02919, United States

Location

Thesan Site 2

Santo Domingo, Dominican Republic

Location

Thesan Site 1

San Pedro Sula, Honduras

Location

MeSH Terms

Conditions

Acne Vulgaris; Lymphoma, Follicular

Interventions

Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Howard Welgus, MD

  Thesan Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 10, 2016
• Study Start: June 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1); US (4); DO (1)