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To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis

NCT03880357 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 485

Last updated 2019-03-19

No results posted yet for this study

Summary

To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.

Conditions

  • Scalp Psoriasis

Interventions

DRUG

Betamethasone Scalp Suspension 0.064%;0.0005%

applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.

DRUG

Taclonex®

applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.

DRUG

Placebo topical suspension

applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Natalie Yantovskiy · Taro Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2019-03-15
Completion
2019-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03880357 on ClinicalTrials.gov