- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645499
An Open-Label Study to Assess Safety
November 29, 2022 updated by: Taro Pharmaceuticals USA
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28217
- Catawba Research, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
|
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
|
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
|
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
|
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
|
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
Time Frame: 84 Days
|
number of participants with adrenal suppression developed during the treatment with the study drug
|
84 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Natalie Yantovskiy, Taro Pharmaceuticals Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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