An Open-Label Study to Assess Safety

Phase 1

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Topical TA-102 A; Drug: Topical TA-102 B; Drug: Topical TA-102 C; Drug: Topical TA-102 D; Drug: Topical TA-102 E

• Registration Number: NCT03645499
• Lead Sponsor: Taro Pharmaceuticals USA

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.

Study Timeline

• Study Start: 2018-04-04
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Primary Completion: 2019-10-24
• Study Completion: 2020-01-07
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical TA-102 A	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
Topical TA-102 B	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
Topical TA-102 C	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
Topical TA-102 D	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
Topical TA-102 E	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

Primary Outcome Measures

Name	Time	Method
number of participants with adrenal suppression	84 Days	number of participants with adrenal suppression developed during the treatment with the study drug

Trial Locations

Locations (1)

Catawba Research, LLC; 🇺🇸 Charlotte, North Carolina, United States