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Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis

NCT03298581 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-06-14

No results posted yet for this study

Summary

This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult patients with moderate to severe plaque psoriasis. At least 40 eligible patients with plaque psoriasis that satisfy all eligibility criteria will be enrolled into the study

Conditions

Interventions

DRUG

Halobetasol Propionate

Experimental: Treatment with topical halobetasol spray 0.05% Patients will instructed o apply halobetasol spray twice daily for 28 days and not to rub over the affected area after application of spray.

Sponsors & Collaborators

  • Novum Pharmaceutical Research Services

    collaborator INDUSTRY

  • Sun Pharmaceutical Industries Limited

    lead INDUSTRY

Principal Investigators

  • Rajinder k Jalali, MD · Sun Pharmaceutical Industries Limited

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2018-01-31
Completion
2018-01-31
FDA Drug
Yes

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Entities

Diseases

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 NCT03298581 on ClinicalTrials.gov