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

• Status: Completed
• Trial end date: 2018-06-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aclaris Therapeutics, Inc.
• Treatments: Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

-Documented clinical diagnosis of rosacea.

Exclusion Criteria:

• 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.