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An Open-Label Study to Assess Safety

Primary Purpose

Plaque Psoriasis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Topical TA-102 A

Topical TA-102 B

Topical TA-102 C

Topical TA-102 D

Topical TA-102 E

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis.
Definite clinical diagnosis of stable plaque psoriasis for at least 6 months.
Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of plaque psoriasis.

Exclusion Criteria:

Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
History of allergy or sensitivity to retinoid, corticosteroids and/or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the Subject or the results of the study.

Sites / Locations

Catawba Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Topical TA-102 A

Topical TA-102 B

Topical TA-102 C

Topical TA-102 D

Topical TA-102 E

Arm Description

A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily

Outcomes

Primary Outcome Measures

number of participants with adrenal suppression

number of participants with adrenal suppression developed during the treatment with the study drug

Secondary Outcome Measures

Full Information

NCT ID

NCT03645499

First Posted

August 21, 2018

Last Updated

November 29, 2022

Sponsor

Taro Pharmaceuticals USA

1. Study Identification

Unique Protocol Identification Number

NCT03645499

Brief Title

An Open-Label Study to Assess Safety

Official Title

An Open-Label Study to Assess the Efficacy and Potential for Adrenal Suppression Following Maximal Use Treatment With TA-102 Topical Formulations in Subjects With Plaque Psoriasis.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

April 4, 2018 (Actual)

Primary Completion Date

October 24, 2019 (Actual)

Study Completion Date

January 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taro Pharmaceuticals USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

An Open-Label study to assess safety

Detailed Description

An Open-Label study to assess the efficacy and potential for adrenal suppression following maximal use treatment with TA-102 topical formulations in subjects with Plaque Psoriasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Topical TA-102 A

Arm Type

Experimental

Arm Description

A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily

Arm Title

Topical TA-102 B

Arm Type

Experimental

Arm Description

A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily

Arm Title

Topical TA-102 C

Arm Type

Experimental

Arm Description

A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily

Arm Title

Topical TA-102 D

Arm Type

Experimental

Arm Description

A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily

Arm Title

Topical TA-102 E

Arm Type

Experimental

Arm Description

A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily

Intervention Type

Drug

Intervention Name(s)

Topical TA-102 A

Intervention Description

applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Topical TA-102 B

Intervention Description

applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Topical TA-102 C

Intervention Description

applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Topical TA-102 D

Intervention Description

applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Topical TA-102 E

Intervention Description

applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

Primary Outcome Measure Information:

Title

number of participants with adrenal suppression

Description

number of participants with adrenal suppression developed during the treatment with the study drug

Time Frame

84 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis. Definite clinical diagnosis of stable plaque psoriasis for at least 6 months. Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of plaque psoriasis. Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation. History of allergy or sensitivity to retinoid, corticosteroids and/or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the Subject or the results of the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Natalie Yantovskiy

Organizational Affiliation

Taro Pharmaceuticals Inc

Official's Role

Study Director

Facility Information:

Facility Name

Catawba Research, LLC

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28217

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

An Open-Label Study to Assess Safety

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