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BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis

NCT03122353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 699

Last updated 2018-03-07

No results posted yet for this study

Summary

This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.

Conditions

  • Scalp Psoriasis

Interventions

DRUG

Calcipotriene and betamethasone suspension

Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%

DRUG

Taclonex

Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%

DRUG

Placebo

vehicle used as placebo

Sponsors & Collaborators

  • Tolmar Inc.

    lead INDUSTRY

Principal Investigators

  • Jim Joffrion · Catawba Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-11
Primary Completion
2017-11-15
Completion
2017-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03122353 on ClinicalTrials.gov