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A Study Comparing Oxymetazoline 1% Cream to RHOFADE

NCT ID: NCT05148689

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-23

Study Completion Date

2019-05-31

Brief Summary

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randomized, double-blind, placebo controlled

Detailed Description

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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.

Conditions

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Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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test product

Oxymetazoline Cream, 1%

Group Type EXPERIMENTAL

Oxymetazoline hydrochloride Cream, 1%

Intervention Type DRUG

Cream

reference

Rhofade™ (oxymetazoline) cream, 1%

Group Type ACTIVE_COMPARATOR

Rhofade™ (oxymetazoline) cream, 1%

Intervention Type DRUG

cream

placebo

Vehicle of Test product

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

cream

Interventions

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Oxymetazoline hydrochloride Cream, 1%

Cream

Intervention Type DRUG

Rhofade™ (oxymetazoline) cream, 1%

cream

Intervention Type DRUG

Placebo

cream

Intervention Type DRUG

Other Intervention Names

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Oxymetazoline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelly Walker

Role: STUDY_CHAIR

WayCro / Trial Clinsultants

Locations

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WAYcro

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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XMTC-1810

Identifier Type: -

Identifier Source: org_study_id