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.
Overview
- Phase
- Phase 1
- Intervention
- Topical TA-102 A
- Conditions
- Plaque Psoriasis
- Sponsor
- Taro Pharmaceuticals USA
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- number of participants with adrenal suppression
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
An Open-Label study to assess safety
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
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
Intervention: Topical TA-102 A
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
Intervention: Topical TA-102 B
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
Intervention: Topical TA-102 C
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
Intervention: Topical TA-102 D
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
Intervention: Topical TA-102 E
Outcomes
Primary Outcomes
number of participants with adrenal suppression
Time Frame: 84 Days
number of participants with adrenal suppression developed during the treatment with the study drug