An Open-Label Study to Assess Safety

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03645499

Enrollment

88

Registered

2018-08-24

Start date

2018-04-04

Completion date

2020-01-07

Last updated

2022-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

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.

Interventions

DRUGTopical TA-102 A

applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

DRUGTopical TA-102 B

applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

DRUGTopical TA-102 C

applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

DRUGTopical TA-102 D

applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

DRUGTopical TA-102 E

applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks

Sponsors

Sun Pharmaceutical Industries, Inc.

Lead SponsorINDUSTRY

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
number of participants with adrenal suppression	84 Days	number of participants with adrenal suppression developed during the treatment with the study drug

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026