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

Primary Purpose

Acne Vulgaris

Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vehicle
TSN2898
TSN2898
TSN2898
Sponsored by
Thesan Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, topical, SCD-1 inhibitor, moderate, severe

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • Thesan Site 4
  • Thesan Site 3
  • Thesan Site 6
  • Thesan Site 5
  • Thesan Site 2
  • Thesan Site 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Vehicle

Low Dose Active

Mid Dose Active

High Dose Active

Arm Description

Vehicle gel

Low Dose of TSN2898

Mid Dose of TSN2898

High Dose of TSN2898

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Non-inflammatory lesion counts
Absolute change from Baseline
Absolute change from Baseline for inflammatory plus non-inflammatory lesions
Percent change from Baseline for inflammatory and non-inflammatory lesions
Investigator's Global Assessment of Acne Severity Score (IGA)

Full Information

First Posted
May 26, 2016
Last Updated
April 24, 2017
Sponsor
Thesan Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02796066
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Protocol not approved
Study Start Date
June 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thesan Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne, topical, SCD-1 inhibitor, moderate, severe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle gel
Arm Title
Low Dose Active
Arm Type
Experimental
Arm Description
Low Dose of TSN2898
Arm Title
Mid Dose Active
Arm Type
Experimental
Arm Description
Mid Dose of TSN2898
Arm Title
High Dose Active
Arm Type
Experimental
Arm Description
High Dose of TSN2898
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Topical gel
Intervention Description
Applied once a day
Intervention Type
Drug
Intervention Name(s)
TSN2898
Other Intervention Name(s)
Topical gel
Intervention Description
Applied once a day
Intervention Type
Drug
Intervention Name(s)
TSN2898
Other Intervention Name(s)
Topical gel
Intervention Description
Applied once a day
Intervention Type
Drug
Intervention Name(s)
TSN2898
Other Intervention Name(s)
Topical gel
Intervention Description
Applied once a day
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Non-inflammatory lesion counts
Description
Absolute change from Baseline
Time Frame
12 weeks
Title
Absolute change from Baseline for inflammatory plus non-inflammatory lesions
Time Frame
12 weeks
Title
Percent change from Baseline for inflammatory and non-inflammatory lesions
Time Frame
12 weeks
Title
Investigator's Global Assessment of Acne Severity Score (IGA)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Welgus, MD
Organizational Affiliation
Thesan Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Thesan Site 4
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Thesan Site 3
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Thesan Site 6
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27626
Country
United States
Facility Name
Thesan Site 5
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Thesan Site 2
City
Santo Domingo
Country
Dominican Republic
Facility Name
Thesan Site 1
City
San Pedro Sula
Country
Honduras

12. IPD Sharing Statement

Plan to Share IPD
No

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

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