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An Open-Label Study to Assess Safety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645499
Recruitment Status : Unknown
Verified September 2019 by Taro Pharmaceuticals USA.
Recruitment status was:  Active, not recruiting
First Posted : August 24, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Description
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Brief Summary:
An Open-Label study to assess safety

Condition or disease Intervention/treatment Phase
Plaque Psoriasis 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 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. number of participants with adrenal suppression [ Time Frame: 84 Days ]
    number of participants with adrenal suppression developed during the treatment with the study drug


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645499


Locations
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United States, North Carolina
Catawba Research, LLC
Charlotte, North Carolina, United States, 28217
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Director: Natalie Yantovskiy Taro Pharmaceuticals Inc
More Information
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT03645499    
Other Study ID Numbers: DSTO 1723
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases