An Open-Label Study to Assess Safety

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Plaque Psoriasis

Treatments: Drug: Topical TA-102 A; Drug: Topical TA-102 B; Drug: Topical TA-102 E; Drug: Topical TA-102 C; Drug: Topical TA-102 D

Study type: Interventional

Funder types: Industry

Identifiers

NCT03645499

DSTO 1723

Details and patient eligibility

About

An Open-Label study to assess safety

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 5 patient groups

Topical TA-102 A

Experimental group

Description:

A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily

Treatment:

Drug: Topical TA-102 A

Topical TA-102 B

Experimental group

Description:

A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily

Treatment:

Drug: Topical TA-102 B

Topical TA-102 C

Experimental group

Description:

A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily

Treatment:

Drug: Topical TA-102 C

Topical TA-102 D

Experimental group

Description:

A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily

Treatment:

Drug: Topical TA-102 D

Topical TA-102 E

Experimental group

Description:

A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily

Treatment:

Drug: Topical TA-102 E