NCT04358770

Brief Summary

To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

April 21, 2020

Last Update Submit

April 22, 2020

Conditions

Bioequivalence Study

Outcome Measures

Primary Outcomes (1)

  • AUEC0-24 (area under the effect curve)

    value for the blanching intensity vs. time profile

    24 hours

Study Arms (2)

Test

EXPERIMENTAL

Clocortolone Pivalate Cream, 0.1%

Drug: Clocortolone Pivalate

Reference

ACTIVE COMPARATOR

Cloderm® (clocortolone pivalate) Cream, 0.1%

Drug: Clocortolone Pivalate

Interventions

Clocortolone PivalateDRUG

Cream, 0.1%

Also known as: Clocortolone
ReferenceTest

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal or clinically insignificant dermatological history the Screening visit and Day 1dosing;

You may not qualify if:

  • Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
  • History of hypersensitivity to the study products or any topical or systemic corticosteroids;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WayCro

Dallas, Texas, 75234, United States

Location

MeSH Terms

Interventions

clocortolone pivalateclocortolone

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: single-exposure, open-label, vasoconstriction response study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

March 2, 2018

Primary Completion

April 27, 2018

Study Completion

May 11, 2018

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)