An Open-Label Study to Assess Safety

NCT ID: NCT03645499

Last Updated: 2022-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-04

Study Completion Date

2020-01-07

Brief Summary

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An Open-Label study to assess safety

Detailed Description

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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.

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical TA-102 A

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

Group Type EXPERIMENTAL

Topical TA-102 A

Intervention Type DRUG

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

Topical TA-102 B

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

Group Type EXPERIMENTAL

Topical TA-102 B

Intervention Type DRUG

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

Topical TA-102 C

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

Group Type EXPERIMENTAL

Topical TA-102 C

Intervention Type DRUG

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

Topical TA-102 D

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

Group Type EXPERIMENTAL

Topical TA-102 D

Intervention Type DRUG

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

Topical TA-102 E

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

Group Type EXPERIMENTAL

Topical TA-102 E

Intervention Type DRUG

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

Interventions

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Topical TA-102 A

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

Intervention Type DRUG

Topical TA-102 B

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

Intervention Type DRUG

Topical TA-102 C

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

Intervention Type DRUG

Topical TA-102 D

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

Intervention Type DRUG

Topical TA-102 E

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis.
2. Definite clinical diagnosis of stable plaque psoriasis for at least 6 months.
3. 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

1. Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
2. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Yantovskiy

Role: STUDY_DIRECTOR

Taro Pharmaceuticals Inc

Locations

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Catawba Research, LLC

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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DSTO 1723

Identifier Type: -

Identifier Source: org_study_id

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