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

April 24, 2017 updated by: Thesan Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Thesan Site 2
  • Honduras
      • San Pedro Sula, Honduras
        • Thesan Site 1
  • United States
    • California
      • San Diego, California, United States, 92123
        • Thesan Site 4
    • Florida
      • Miami, Florida, United States, 33144
        • Thesan Site 3
    • North Carolina
      • High Point, North Carolina, United States, 27626
        • Thesan Site 6
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Thesan Site 5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Vehicle gel
Drug: Vehicle
Applied once a day
Other Names:
  • Topical gel
Experimental: Low Dose Active
Low Dose of TSN2898
Drug: TSN2898
Applied once a day
Other Names:
  • Topical gel
Experimental: Mid Dose Active
Mid Dose of TSN2898
Drug: TSN2898
Applied once a day
Other Names:
  • Topical gel
Experimental: High Dose Active
High Dose of TSN2898
Drug: TSN2898
Applied once a day
Other Names:
  • Topical gel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thesan Pharmaceuticals, Inc.

Investigators

  • Study Director: Howard Welgus, MD, Thesan Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

May 26, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSN2898-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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