A Study Comparing Oxymetazoline 1% Cream to RHOFADE

Phase 1

Completed

• Conditions: Bioequivalence
• Interventions: Drug: Oxymetazoline hydrochloride Cream, 1%; Drug: Placebo; Drug: Rhofade™ (oxymetazoline) cream, 1%

• Registration Number: NCT05148689
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

randomized, double-blind, placebo controlled

Detailed Description

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.

Study Timeline

• Study Start: 2018-02-23
• Primary Completion: 2019-03-21
• Study Completion: 2019-05-31
• Study First Submitted: 2021-11-23
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-07
• Last Update Submitted: 2021-12-07
• Study First Posted: 2021-12-08
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
test product	Oxymetazoline hydrochloride Cream, 1%	Oxymetazoline Cream, 1%
placebo	Placebo	Vehicle of Test product
reference	Rhofade™ (oxymetazoline) cream, 1%	Rhofade™ (oxymetazoline) cream, 1%

Primary Outcome Measures

Name	Time	Method
erythema response success	21 day	at least a 2-grade improvement in both CEA and PSA

Trial Locations

Locations (1)

WAYcro; 🇺🇸 Dallas, Texas, United States