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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 15, 2018

Interventions

  • 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])

Arms, Groups and Cohorts

  • Experimental: Oxymetazoline + Energy-Based Therapy
    • 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%.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
    • Time Frame: Baseline (Day 1) to Day 56
    • 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.
  • Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point
    • Time Frame: Baseline (Day 1) to Day 56
    • 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.
  • Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician’s Telangiectasia Assessment (CTA) at Any Time-point
    • Time Frame: Baseline (Day 1) to Day 56
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aclaris Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nancy Alvandi, Study Director, Allergan

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