A Study Comparing Oxymetazoline 1% Cream to RHOFADE

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Bioequivalence

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05148689

XMTC-1810

Details and patient eligibility

About

randomized, double-blind, placebo controlled

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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82 participants in 3 patient groups, including a placebo group

test product

Experimental group

Description:

Oxymetazoline Cream, 1%

Treatment:

Drug: Oxymetazoline hydrochloride Cream, 1%

reference

Active Comparator group

Description:

Rhofade™ (oxymetazoline) cream, 1%

Treatment:

Drug: Rhofade™ (oxymetazoline) cream, 1%

placebo

Placebo Comparator group

Description:

Vehicle of Test product

Treatment:

Drug: Placebo