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



Status:Completed
Conditions:Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:6/30/2018
Start Date:December 4, 2017
End Date:June 15, 2018

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

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.


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.
We found this trial at
4
sites
Hackensack, New Jersey 07601
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Hackensack, NJ
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Chestnut Hill, Massachusetts 02467
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Chestnut Hill, MA
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317 East 34th Street
New York, New York 10016
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New York, NY
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Sacramento, California 95819
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Sacramento, CA
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