An Open-Label Study to Assess Safety

Study Overview
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Brief Summary
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An Open-Label study to assess safety

Detailed Description
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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.

Official Title
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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.

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |