Trial intelligence / Profile preview

Clobetasol 0.05% Ointment for Toxic Epidermal Necrolysis

NCT02319616Phase 2

Key facts

Status: Withdrawn
Start: Nov 2016
Primary completion: Feb 2019
Countries: 1
Sponsor: University of California, Davis
Modality: Small Molecules

Drugs: clobetasol
Conditions: toxic epidermal necrolysis (TEN)

Overview

Phase 2, randomised, double-blind trial in toxic epidermal necrolysis (TEN) comparing Clobetasol 0.05% ointment with Placebo (2 arms). Primary endpoints: Safety (numeric cellulitis score) at 14 days and Time to Cessation of Skin Detachment at 14 days. Planned start Nov 2016; status: withdrawn.

Design

2 arms

Study design: RandomizedDouble-blind

Clobetasol 0.05% ointment
Experimental arm receiving topical clobetasol 0.05% ointment.
Placebo
Comparator arm receiving topical petrolatum ointment.

Endpoints

Primary

Safety (numeric cellulitis score)14 days
Time to Cessation of Skin Detachment14 days

Secondary

Time to 90% re-epithelialization14 days
Percent Affected Surface Area14 days
Percent Affected Surface Area Detached Skin14 days

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