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NCT03645499 Clinical Trial

An Open-Label Study to Assess Safety

Plaque Psoriasis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03645499
Other study ID # DSTO 1723
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 4, 2018
Est. completion date January 7, 2020

Study information
Verified date November 2022
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An Open-Label study to assess safety

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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date January 7, 2020
Est. primary completion date October 24, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Topical TA-102 A
applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
• Topical TA-102 B
applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
• Topical TA-102 C
applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
• Topical TA-102 D
applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
• Topical TA-102 E
applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

Locations
Country Name City State
United States Catawba Research, LLC Charlotte North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of participants with adrenal suppression number of participants with adrenal suppression developed during the treatment with the study drug 84 Days
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