Phase 4
N=46
Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea
Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT03380390 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) — 5; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxymetazoline HCL 1.0% Cream (Drug); Energy-Based Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aclaris Therapeutics, Inc.
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
5; 0 | — |
| PRIMARY Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point |
8; 21; 37; 42; 37; 43 | — |
| PRIMARY Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician's Telangiectasia Assessment (CTA) at Any Time-point |
3 | — |
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 facial erythema associated with rosacea.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03380390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.