Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea

Completed · Phase 4

Conditions studied: Rosacea

In brief

This study will evaluate the safety and tolerability of oxymetazoline HCl cream 1.0% when used as an adjunctive treatment to energy-based therapy for participants with moderate to severe persistent facial erythema associated with rosacea.

Key facts

Study ID

NCT03380390

Run by

Aclaris Therapeutics, Inc.

People needed

46

Starts

2017-12-04

Expected to finish

2018-06-15

Last updated by the study team

2019-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented clinical diagnosis of rosacea.

You may not qualify if…

• History of any of the following conditions: Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, cerebral or coronary insufficiency, thromboangiitis obliterans, scleroderma, Sjögren's syndrome, severe or unstable or uncontrolled cardiovascular disease, or any other current uncontrolled systemic disease
• Diagnosis or presence of any of the following conditions: rosaceaconglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or chronic recurring facial acne
• Current treatment with monoamine oxidase (MAO) inhibitors
• Current treatment with niacin ≥ 500 mg/day
• Greater than 3 inflammatory lesions on the face
• History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit.

Where it is running

• Center for Dermatology and Laser Surgery — Sacramento, California, United States
• SkinCare Physicians — Chestnut Hill, Massachusetts, United States
• Skin Laser and Surgery Specialists of NY/NJ — Hackensack, New Jersey, United States
• Laser & Skin Surgery Center of New York Professional Corporation — New York, New York, United States

Full record on ClinicalTrials.gov

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