NCT05148689

Brief Summary

randomized, double-blind, placebo controlled

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2018

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

February 23, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

1.1 years

First QC Date

November 23, 2021

Last Update Submit

December 7, 2021

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (1)

  • erythema response success

    at least a 2-grade improvement in both CEA and PSA

    21 day

Study Arms (3)

test product

EXPERIMENTAL

Oxymetazoline Cream, 1%

Drug: Oxymetazoline hydrochloride Cream, 1%

reference

ACTIVE COMPARATOR

Rhofade™ (oxymetazoline) cream, 1%

Drug: Rhofade™ (oxymetazoline) cream, 1%

placebo

PLACEBO COMPARATOR

Vehicle of Test product

Drug: Placebo

Interventions

Oxymetazoline hydrochloride Cream, 1%DRUG

Cream

Also known as: Oxymetazoline
test product
Rhofade™ (oxymetazoline) cream, 1%DRUG

cream

reference
PlaceboDRUG

cream

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or non-pregnant female aged ≥18 years with a clinical diagnosis of facial rosacea;
  • Provided IRB approved written informed consent;
  • A CEA score of ≥3 prior to study drug application
  • A PSA score of ≥3 prior to study drug application

You may not qualify if:

  • Female subjects who were pregnant, nursing, or had planned to become pregnant during study participation;
  • History of hypersensitivity to the study product;
  • Presence of ≥3 facial inflammatory lesions of rosacea;
  • Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, and isolated pustulosis of the chin);
  • Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression;
  • Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that could interfere with diagnosis or study assessments;
  • Presence of significant hypertension or circulatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WAYcro

Dallas, Texas, 75234, United States

Location

MeSH Terms

Interventions

Oxymetazoline

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kelly Walker

    WayCro / Trial Clinsultants

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2021

First Posted

December 8, 2021

Study Start

February 23, 2018

Primary Completion

March 21, 2019

Study Completion

May 31, 2019

Last Updated

December 8, 2021

Record last verified: 2021-12

Locations

US(1)