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Completed

NCT Number: NCT03380390

Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants 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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Dermatology and Laser Surgery, Sacramento, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxymetazoline HCL 1.0% Cream

Drug

Oxymetazoline HCl cream 1.0% once daily application

Other names: Rhofade

Energy-Based Therapy

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Aclaris Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2017
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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