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Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea

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ClinicalTrials.gov Identifier: NCT04153188
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Candela Corporation

Brief Summary:
This study will compare treatment outcome with pulsed dye laser, when used used as an adjunctive treatment to oxymetazoline HCl 1% cream, compared to oxymetazoline HCL 1% cream alone, for patients with moderate or severe erythematotelangiectatic rosacea.

Condition or disease Intervention/treatment Phase
Erythematotelangiectatic Rosacea Device: The Vbeam® Prima System Drug: Oxymetazoline HCL 1% Cream Phase 4

Detailed Description:

This is a prospective, two-arm randomized, baseline-controlled, pilot study to evaluate treatment outcome of 3 Vbeam® Prima PDL treatments in subjects applying once-daily RHOFADE® topical oxymetazoline HCL 1.0% cream for improvement in erythematotelangiectatic rosacea. Treatment outcome will be compared to oxymetazoline HCL 1% cream alone.

Subjects with moderate or severe (Grade 3 or 4) erythematotelangiectatic rosacea on the validated Clinical Erythema Assessment (CEA) Scale and Subject Self-Assessment (SSA) Scale will be enrolled and randomized to one of two study arms:

Arm 1- 3 monthly treatments with Vbeam® PDL with daily RHOFADE® topical oxymetazoline HCL 1.0% cream.

Arm 2 -Treatment with daily RHOFADE® topical oxymetazoline HCL 1.0% cream only.

All subjects will apply RHOFADE® cream daily during the 6-month study. After 1-month of RHOFADE® cream, subjects in the combined treatment Arm 1 will receive the first of three monthly Vbeam® PDL treatments (at 4-week intervals) with a 3-day washout of cream before each treatment.

Investigators will assess erythema severity, global aesthetic improvement and vessel size improvement with treatment at 1, 2, 3 and 6-months' post-baseline. Subject satisfaction will be assessed. Safety assessments will be conducted at each study visit, and subjects in Arm 1 will also be assessed for treatment-associated discomfort and post-treatment response following PDL treatments.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects randomized at baseline to either 3 monthly treatments with PDL and daily oxymetazoline 1.0% cream (Arm 1) or oxymetazoline cream alone (Arm 2).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate Vbeam® Prima Pulsed Dye Laser (PDL) Treatment and RHOFADE® (Oxymetazoline HCL, 1% Cream) for Erythematotelangiectatic Rosacea
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Pulsed Dye Laser & Oxymetazoline HCL 1% Cream
Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments.
Device: The Vbeam® Prima System
3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.
Other Names:
  • Vbeam® Prima Pulsed Dye Laser Treatment
  • Pulsed Dye Laser Treatment
  • PDL Treatment

Drug: Oxymetazoline HCL 1% Cream
Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Other Name: RHOFADE®

Active Comparator: Oxymetazoline HCL 1% Cream
Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study.
Drug: Oxymetazoline HCL 1% Cream
Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Other Name: RHOFADE®




Primary Outcome Measures :
  1. Change From Baseline in Clinician Erythema Assessment (CEA) at 6-Month Post-Baseline [ Time Frame: 6 months post-baseline ]
    Change from baseline in Clinician Erythema Assessment (CEA) score at 6-month post-baseline will be assessed for both arms and compared. CEA is graded according to 5-point scale (0=Clear to 4=Severe). A higher score than baseline indicates a worse outcome.


Secondary Outcome Measures :
  1. Change From Baseline in Clinician Erythema Assessment (CEA) [ Time Frame: 1, 2 and 3 months post-baseline ]
    Change in CEA from baseline will be assessed for both study arms and compared. CEA is graded according to 5-point scale (0=Clear to 4=Severe). A higher score than baseline indicates a worse outcome.

  2. Change From Baseline in Subject Self-Assessment (SSA) [ Time Frame: 1, 2, 3 and 6 months post-baseline ]
    Change in SSA from baseline. SSA is graded according to 5-point scale (0=Clear of unwanted redness to 4=Completely unacceptable redness). A higher score indicates worse outcome.

  3. Measurement of Global Aesthetic Improvement (GAI) Scale [ Time Frame: 2, 3 and 6 months post-baseline ]
    Investigator measurement of Global Aesthetic Improvement (GAI) with treatment. GAI is graded according to 4-point scale (0=Excellent improvement to 4=No change). A higher score indicates a worse outcome.

  4. Measurement of vessel size [ Time Frame: 2, 3 and 6 months post-baseline ]
    Investigator assessment of vessel size with treatment. Improvement in vessel size is graded according to 4-point scale (0=76-100% improvement (excellent) to 4=No response). A higher score indicates a worse outcome.

  5. Measurement of the percentage of subjects reporting satisfaction [ Time Frame: 1, 2, 3 and 6 months post-baseline ]
    Subject satisfaction is graded according to 5-point scale (0=Very Satisfied to 4=Very Dissatisfied). A score of 0 or 1 indicates satisfaction with treatment outcome.

  6. Measurement of pain with PDL treatment: visual analog scale [ Time Frame: 1, 2 and 3 months post-baseline ]
    A standard 10-centimeter visual analog scale from 0=No pain to 10=worst pain is used by subjects to report pain level associated with PDL treatment. A higher score indicates greater pain/discomfort with treatment.


Other Outcome Measures:
  1. Adverse Event Reporting [ Time Frame: 6 months ]
    Measurement of frequency, severity and type of adverse events in both study arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject is a healthy male or female of 18 to 75 years of age.
  2. Subject has erythematotelangiectatic rosacea with clinician erythema assessment (CEA) and subject self-assessment (SSA) of "moderate" or "severe" (Grade 3 or 4).
  3. Fitzpatrick Skin Type I - VI.
  4. Subject must be able to read, understand and sign the Informed Consent Form.
  5. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
  6. Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period up to 6 months post-baseline.
  7. Subject is willing to have photographs taken of the treated area that will be used, de-identified, in evaluations and may be used, de-identified, in presentations and/or publications.
  8. For female candidates - subject must be post-menopausal, or surgically sterilized, or using a medically acceptable form of birth control during the entire course of the study.

Exclusion Criteria:

  1. Subject is pregnant or planning to become pregnant during the study duration.
  2. Subject has an active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
  3. Subject has an implant in the treated area (such as metal plates or screws) or an injected chemical substance.
  4. Subject has a known collagen (connective tissue) disorder, vascular disease, scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
  5. Subject has a history of diseases stimulated by heat or sun exposure, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
  6. Subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
  7. Having or undergoing any form of treatment for active cancer or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
  8. Subject is suffering from significant concurrent illness, such as such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
  9. Subject has an infection or is suffering from current or has a history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: photodermatoses, active acne, excessive skin dryness, psoriasis, eczema, rash, open wounds, varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
  10. Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use might be requested as per the subject's physician discretion).
  11. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
  12. Subject has a history of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
  13. Subject has a history of keloid scarring or of abnormal wound healing.
  14. Subject has a known photosensitivity to the device's laser wavelengths, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.
  15. Subject has undergone any surgical, light-based therapy or radiofrequency (RF) procedures in the treatment area within 3 months of treatment or during the study.
  16. Having undergone any other surgery in the treated area within 3 months of treatment (or more if skin has not healed completely) or during the study.
  17. Subject has a tattoo or permanent make-up in the treated area.
  18. Subject has systemically used retinoids or antioxidants within 1 month of treatment or during the study.
  19. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  20. Participation in a study of another device or drug within three months prior to enrollment or during the study.
  21. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

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): NCT04153188


Contacts
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Contact: Konika P Schallen, MD +1 904 6549629 konikap@candelamedical.com

Locations
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United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Razia Ludin, MHA BSc    704-973-3687    RaziaL@carolinaskin.com   
Principal Investigator: Girish S Munavalli, MD         
United States, Texas
Dermatology & Laser Surgery Center Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Candela Corporation
Investigators
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Study Director: Konika P Schallen, MD Candela Corporation
Publications:
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Responsible Party: Candela Corporation
ClinicalTrials.gov Identifier: NCT04153188    
Other Study ID Numbers: DHF24671
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Candela Corporation:
Erythema
Rosacea
Telangiectasia
pulsed dye laser
oxymetazoline hydrochloride 1% cream
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Phenylephrine
Oxymetazoline
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