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

Aclaris Therapeutics

Status and phase: Completed; Phase 4

Conditions: Rosacea

Treatments: Device: Energy-Based Therapy; Drug: Oxymetazoline HCL 1.0% Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03380390

CMO-MA-MED-0530

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

46 participants in 1 patient group

Oxymetazoline + Energy-Based Therapy

Experimental group

Description:

Participants will receive energy-based therapy (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%.

Treatment:

Drug: Oxymetazoline HCL 1.0% Cream

Device: Energy-Based Therapy