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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03380390
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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 facial erythema associated with rosacea.

Condition or disease Intervention/treatment Phase
Rosacea Drug: Oxymetazoline HCL 1.0% Cream Device: Energy-Based Therapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-Label, Interventional Study on the Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Subjects With Rosacea
Actual Study Start Date : December 4, 2017
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
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%.
Drug: Oxymetazoline HCL 1.0% Cream
Oxymetazoline HCl cream 1.0% once daily application
Other Name: Rhofade

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




Primary Outcome Measures :
  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 Worsening from Baseline in the Investigator's Dermal Tolerability Assessment at any Time-point [ Time Frame: Baseline (Day 1) to Day 56 ]
    The investigator will assess dryness and scaling in the treatment area using 4-point scales. Dryness: 0=none (no dryness) to 3=severe (marked roughness). Scaling: 0=none (no peeling) to 3=severe (heavy scale production). 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.

  3. Percentage of Participants with at Least a 1-Grade Worsening from Baseline in the Participant's Dermal Tolerability Assessment at any Time-point [ Time Frame: Baseline (Day 1) to Day 56 ]
    The investigator will ask the participant if he or she is experiencing stinging/burning and pruritis/itching using 4-point scales. Stinging/burning: 0=none (no stinging/burning) to 3=severe (Hot, tingling/stinging sensation that has caused definite discomfort). Itching: 0=none (Normal, no itching in the application area) to 3=severe (Definite, continuous discomfort interfering with normal daily activities). 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380390


Locations
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United States, California
Center for Dermatology and Laser Surgery
Sacramento, California, United States, 95819
United States, Massachusetts
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
United States, New Jersey
Skin Laser and Surgery Specialists of NY/NJ
Hackensack, New Jersey, United States, 07601
United States, New York
Laser & Skin Surgery Center of New York Professional Corporation
New York, New York, United States, 10016
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Nancy Alvandi Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03380390     History of Changes
Other Study ID Numbers: CMO-MA-MED-0530
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Oxymetazoline
Phenylephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Protective Agents