A Study Comparing Oxymetazoline 1% Cream to RHOFADE

• Status: Completed
• Trial end date: 2019-05-31
• Target enrollment: 0
• Participant gender: All

Summary

randomized, double-blind, placebo controlled

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taro Pharmaceuticals USA
• Treatments: Oxymetazoline; Phenylephrine

Criteria

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