Status:
COMPLETED
Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea
Lead Sponsor:
Aclaris Therapeutics, Inc.
Conditions:
Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 fa...
Eligibility Criteria
Inclusion
- Documented clinical diagnosis of rosacea.
Exclusion
- 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.
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03380390
Start Date
December 4 2017
End Date
June 15 2018
Last Update
September 4 2019
Active Locations (4)
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1
Center for Dermatology and Laser Surgery
Sacramento, California, United States, 95819
2
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
3
Skin Laser and Surgery Specialists of NY/NJ
Hackensack, New Jersey, United States, 07601
4
Laser & Skin Surgery Center of New York Professional Corporation
New York, New York, United States, 10016