An Open-Label Study to Assess Safety

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.

An Open-Label study to assess safety

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28217
      • Catawba Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Topical TA-102 A; applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
Experimental: 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	Drug: Topical TA-102 B; applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
Experimental: 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	Drug: Topical TA-102 C; applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
Experimental: 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	Drug: Topical TA-102 D; applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
Experimental: 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	Drug: Topical TA-102 E; applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with adrenal suppression	number of participants with adrenal suppression developed during the treatment with the study drug	84 Days

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA
• Investigators: Study Director: Natalie Yantovskiy, Taro Pharmaceuticals Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): October 24, 2019
• Study Completion (Actual): January 7, 2020

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: DSTO 1723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No