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

Study Overview
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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.

Official Title
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Multicenter, Open-Label, Interventional Study on the Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Subjects With Rosacea

Conditions
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Rosacea

Intervention / Treatment
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* Drug: Oxymetazoline HCL 1.0% Cream
* Device: Energy-Based Therapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxymetazoline + Energy-Based Therapy<br>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%. | Drug: Oxymetazoline HCL 1.0% Cream<br>* Oxymetazoline HCl cream 1.0% once daily application<br>* Other names: Rhofade;Device: Energy-Based Therapy<br>* Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL])<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. An SAE is any untoward medical occurrence or effect that, at any dose: Results in death, Is life-threatening, Requires or prolongs inpatient hospitalization, Results in persistent or significant disability/incapacity or Results in a congenital anomaly/birth defect. | Baseline (Day 1) to Day 56 | 
| Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | The investigator will assess erythema in the treatment area using a 5-point scale. (Grade 0= Clear Skin with no signs of erythema, Grade 1=Almost clear of erythema, slight redness, Grade 2=Mild erythema, definite redness, Grade 3= Moderate erythema, marked redness, Grade 4=Severe erythema, fiery redness). The percentage of participants with at least a 1-point improvement (decrease) in the score compared to Baseline at any time-point will be reported. | Baseline (Day 1) to Day 56 | 
| Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician's Telangiectasia Assessment (CTA) at Any Time-point | The investigator will assess the overall severity of telangiectasia (spider veins) on the participant's facing using a 5-point scale where 0=Clear skin with no signs of telangiectasia to 4=Severe, with the presence of many visible telangiectasia. The percentage of participants with at least a 1-point worsening (increase) in the score compared to Baseline at any time-point will be reported. | Baseline (Day 1) to Day 56 |