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

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380390
• Other study ID #: CMO-MA-MED-0530
• Status: Completed
• Phase: Phase 4
• Start date: December 4, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: June 2018
• Source: Aclaris Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Oxymetazoline HCL 1.0% Cream
Oxymetazoline HCl cream 1.0% once daily application

Device:
• Energy-Based Therapy
Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL])

Locations

Country	Name	City	State
United States	SkinCare Physicians	Chestnut Hill	Massachusetts
United States	Skin Laser and Surgery Specialists of NY/NJ	Hackensack	New Jersey
United States	Laser & Skin Surgery Center of New York Professional Corporation	New York	New York
United States	Center for Dermatology and Laser Surgery	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Aclaris Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   More Information