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OpenTrials
Completed

NCT Number: NCT03645499

An Open-Label Study to Assess Safety

An Open-Label study to assess safety

Completed

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Catawba Research, LLC

Charlotte, North Carolina, 28217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical TA-102 A

Drug

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

Topical TA-102 B

Drug

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

Topical TA-102 C

Drug

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

Topical TA-102 D

Drug

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

Topical TA-102 E

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 24, 2018
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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