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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2018-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Rosacea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxymetazoline + Energy-Based Therapy

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%.

Group Type EXPERIMENTAL

Oxymetazoline HCL 1.0% Cream

Intervention Type DRUG

Oxymetazoline HCl cream 1.0% once daily application

Energy-Based Therapy

Intervention Type DEVICE

Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])

Interventions

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Oxymetazoline HCL 1.0% Cream

Oxymetazoline HCl cream 1.0% once daily application

Intervention Type DRUG

Energy-Based Therapy

Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])

Intervention Type DEVICE

Other Intervention Names

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Rhofade

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No