A Study Comparing Oxymetazoline 1% Cream to RHOFADE

Bioequivalence Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148689
• Other study ID #: XMTC-1810
• Status: Completed
• Phase: Phase 1
• Start date: February 23, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: December 2021
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

randomized, double-blind, placebo controlled

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 31, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bioequivalence

Intervention

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

Locations

Country	Name	City	State
United States	WAYcro	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	erythema response success	at least a 2-grade improvement in both CEA and PSA	21 day