An Open-Label Study to Assess Safety

NCT03645499 | Completed Phase 1 FDA Drug

• 1 other identifier: DSTO 1723
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

An Open-Label study to assess safety

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• number of participants with adrenal suppression

  number of participants with adrenal suppression developed during the treatment with the study drug

  84 Days

Study Arms (5)

Topical TA-102 A

EXPERIMENTAL

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

Topical TA-102 B

EXPERIMENTAL

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

Topical TA-102 C

EXPERIMENTAL

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

Topical TA-102 D

EXPERIMENTAL

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

Topical TA-102 E

EXPERIMENTAL

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

Interventions

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 A

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 B

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 C

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 D

Topical TA-102 E DRUG

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

Topical TA-102 E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Catawba Research, LLC

Charlotte, North Carolina, 28217, United States

Location

Study Officials

• Natalie Yantovskiy

  Taro Pharmaceuticals Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 24, 2018
• Study Start: April 4, 2018
• Primary Completion: October 24, 2019
• Study Completion: January 7, 2020
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)