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OpenTrials
Completed

NCT Number: NCT05148689

A Study Comparing Oxymetazoline 1% Cream to RHOFADE

randomized, double-blind, placebo controlled

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WAYcro

Dallas, Texas, 75234, United States

About this study

Subjects in this randomized, double-blind, placebo controlled study will be randomly assigned to treatment sequences with the test product, reference product or placebo control.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Oxymetazoline hydrochloride Cream, 1%

Drug

Cream

Other names: Oxymetazoline

Rhofade™ (oxymetazoline) cream, 1%

Drug

cream

Placebo

Drug

cream

Primary outcomes

  1. erythema response success

    Time frame: 21 day

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

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo Controlled Study, Comparing Oxymetazoline 1% Cream TO RHOFADE in the Treatment of Moderate to Severe Persistent Facial Erythema Assocoated With Rosacea

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 8, 2021
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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