Status:

COMPLETED

To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis

Lead Sponsor:

Sun Pharmaceutical Industries Limited

Conditions:

Dermatitis, Atopic

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.

Detailed Description

This is a Phase II, randomized, double-blind, placebo-controlled study to determine the effect of SCD-044 in subjects with moderate to severe atopic dermatitis.

Eligibility Criteria

Inclusion

  • Aged at least 18 years.
  • Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka.
  • Moderate to severe atopic dermatitis at Screening and Baseline

Exclusion

  • Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study.
  • Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy.
  • History or presence of uveitis
  • \-

Key Trial Info

Start Date :

July 30 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 18 2025

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT04684485

Start Date

July 30 2021

End Date

March 18 2025

Last Update

December 30 2025

Active Locations (58)

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Page 1 of 15 (58 locations)

1

Omni Dermatology

Phoenix, Arizona, United States, 85018

2

Yuma Clinical Trials, LLC

Yuma, Arizona, United States, 85364

3

T. Joseph Raoof Md, Imc./Encino Research Center

Encino, California, United States, 91436

4

Metropolis Dermatology

Los Angeles, California, United States, 90017