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Laser to Aid in Treatment of Keratosis Pilaris on Arms

Primary Purpose

Keratosis Pilaris

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
M22 IPL
Sponsored by
Goldman, Butterwick, Fitzpatrick and Groff
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratosis Pilaris focused on measuring keratosis pilaris, arms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adult males and females aged 18 or older with clinical diagnosis of KP of the posterior upper arms. Subjects in good general health based on investigator's judgment and medical history Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study Understands and accepts the obligation and is logistically able to be present for all visits Is willing to comply with all requirements of the study and sign the informed consent documents Must be willing to maintain usual sun exposure for the duration of the study Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study Subject agrees to avoid any changes in current skincare regimen. Negative urine pregnancy test result at the time of study entry (if applicable) For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment. A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active. Exclusion Criteria: Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study The subject is hypersensitive to light in the visible and/or near infrared wavelength region The subject is taking medication which is known to increase sensitivity to sunlight The subject has a seizure disorder triggered by light The subject has a pacemaker The subject has a metal implant that interferes with the transmission of energy to the electrical field The subject has any embedded electronic devices that give or receive a signal such as Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant Gold or metal allergy The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area or a neuropathic disorder The subject has used topical keratolytics, retinoids, chemical or mechanical exfoliative treatments in the 30 days prior to application of study treatment Dermal fillers, biostimulators, laser treatments, or other energy-based light treatments during the 6-month period before study treatment Subjects with tattoos in the treatment areas Subjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, neoplasm of uncertain behavior, or untreated keratinocyte carcinoma/melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters History of keloid or hypertrophic scarring Subjects with an active bacterial, viral, or fungal infection of the treatment areas The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator Presence of incompletely healed wound(s) in the treatment area Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group A -- Right side is Intervention Arm, Left side is Control Arm

    Group B -- Left side is Intervention Arm, Right side is Control Arm

    Arm Description

    Right Arm will be treated with IPL activation of SNA (Silver Nanoparticles ) and left arm with IPL alone.

    Left Arm will be treated with IPL activation of SNA (Silver Nanoparticles ) and right arm with IPL alone.

    Outcomes

    Primary Outcome Measures

    Erythema Grading Scale by a blinded investigator to assess change (one for each arm)
    Erythema grading scale (Right Arm) 0 No erythema Mild erythema Moderate erythema Severe erythema Very severe erythema Erythema grading scale (Left Arm) 0 No erythema Mild erythema Moderate erythema Severe erythema Very severe erythema
    Textural Change Grading Scale by a blinded investigator (one for each arm)
    Textural change grading scale ( Right Arm) 0 No textural change Mild textural change Moderate textural change Severe textural change Very severe textural change Textural change grading scale (Left Arm) 0 No textural change Mild textural change Moderate textural change Severe textural change Very severe textural change
    Investigator Global Aesthetic Improvement Scale (IGAIS) by a blinded investigator
    Blinded Physician Global Aesthetic Improvement Scale Rating Description Very Much Improved- Optimal cosmetic result in this subject Much Improved- Marked improvement in appearance form the initial condition, but not completely optimal for this subject. Improved- Obvious improvement in appearance from initial condition, but a re- treatment is indicated. No Change- The appearance is essentially the same as the original condition. Worse- The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated") Right Arm Left Arm Not Treated Not Treated

    Secondary Outcome Measures

    Subject Global Aesthetic Improvement Scale (SGAIS)
    Subject Global Aesthetic Improvement Scale Assessment How would you rate the overall change in appearance of your treated areas? Non-treated areas will be checked as "Not Treated" for you. Rating Description Very Much Improved- Optimal cosmetic result in this subject Much Improved- Marked improvement in appearance form the initial condition, but not completely optimal for this subject. Improved- Obvious improvement in appearance from initial condition, but a re-treatment is indicated. No Change- The appearance is essentially the same as the original condition. Worse- The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated") Right Arm Left Arm Not Treated Not Treated

    Full Information

    First Posted
    October 21, 2022
    Last Updated
    March 17, 2023
    Sponsor
    Goldman, Butterwick, Fitzpatrick and Groff
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05666011
    Brief Title
    Laser to Aid in Treatment of Keratosis Pilaris on Arms
    Official Title
    A Single Center, Evaluator-Blinded, Split-Body, Randomized Pilot Study of Intense Pulsed Light Activation of Silver Nanoparticles vs. Intense Pulsed Light Alone in the Treatment of Keratosis Pilaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 20, 2023 (Anticipated)
    Primary Completion Date
    May 30, 2023 (Anticipated)
    Study Completion Date
    May 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Goldman, Butterwick, Fitzpatrick and Groff

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assess efficacy and safety of intense pulsed light (IPL) activation of silver nanoparticles (SNA) versus IPL alone for treatment of keratosis pilaris.
    Detailed Description
    The primary objective of this pilot study is to assess efficacy and safety of intense pulsed light (IPL; StellarM22™ Universal IPL, Lumenis Ltd., Yokneam, Israel) alone versus combination of IPL activation of silver nanoparticles (SNA) for treatment of keratosis pilaris. Prior to first treatment, right and left arms of 10 enrolled subjects will be randomized to combination treatment with IPL activation of SNA (i.e. intervention arm) versus IPL alone (i.e. control arm). The intervention arm will be pre-treated with sugaring to epilate existing hair. This arm will then be treated with 0.5mL of nanoparticle suspension administered with a standard infusion paddle for 5 minutes prior to IPL treatment. Following nanoparticle infusion, excess suspension will be removed from the surface of the skin with a pre-moistened wipe. Once all visible suspension is removed from the skin, the area will be cleansed with an alcohol wipe. If the alcohol wipe shows that the suspension is still present on the surface of the skin, additional pre-moistened wipes will be used to cleanse the skin until the alcohol wipe comes away without visible suspension. IPL will then be applied to the intervention arm. Treatments will be repeated three times, spaced four- to six-weeks apart. After completing all three treatments, patients will return for macroscopic and dermoscopic photography at 1 month and 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratosis Pilaris
    Keywords
    keratosis pilaris, arms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Enrolled subjects will be randomized to combination treatment with IPL activation of SNA (i.e. intervention arm) versus IPL alone (i.e. control arm).
    Masking
    Investigator
    Masking Description
    Blinded Investigator will be unaware of which arm received which treatment
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A -- Right side is Intervention Arm, Left side is Control Arm
    Arm Type
    Experimental
    Arm Description
    Right Arm will be treated with IPL activation of SNA (Silver Nanoparticles ) and left arm with IPL alone.
    Arm Title
    Group B -- Left side is Intervention Arm, Right side is Control Arm
    Arm Type
    Experimental
    Arm Description
    Left Arm will be treated with IPL activation of SNA (Silver Nanoparticles ) and right arm with IPL alone.
    Intervention Type
    Device
    Intervention Name(s)
    M22 IPL
    Other Intervention Name(s)
    StellarM22 Intense Pulsed Light Laser
    Intervention Description
    IPL is an attractive option in the treatment of KP as the provider can utilize cut-off filters to target both melanin for hair removal and erythema with a single device. An added benefit of IPL is the larger crystal size, allowing for efficient coverage of a larger body surface area. IPL has been utilized in the treatment of KP and KP variants, with outcomes showing reductions in both erythema and texture.
    Primary Outcome Measure Information:
    Title
    Erythema Grading Scale by a blinded investigator to assess change (one for each arm)
    Description
    Erythema grading scale (Right Arm) 0 No erythema Mild erythema Moderate erythema Severe erythema Very severe erythema Erythema grading scale (Left Arm) 0 No erythema Mild erythema Moderate erythema Severe erythema Very severe erythema
    Time Frame
    Baseline, Day 30, Day 60, Day 90, Day 110
    Title
    Textural Change Grading Scale by a blinded investigator (one for each arm)
    Description
    Textural change grading scale ( Right Arm) 0 No textural change Mild textural change Moderate textural change Severe textural change Very severe textural change Textural change grading scale (Left Arm) 0 No textural change Mild textural change Moderate textural change Severe textural change Very severe textural change
    Time Frame
    Baseline, Day 30, Day 60, Day 90, Day 110
    Title
    Investigator Global Aesthetic Improvement Scale (IGAIS) by a blinded investigator
    Description
    Blinded Physician Global Aesthetic Improvement Scale Rating Description Very Much Improved- Optimal cosmetic result in this subject Much Improved- Marked improvement in appearance form the initial condition, but not completely optimal for this subject. Improved- Obvious improvement in appearance from initial condition, but a re- treatment is indicated. No Change- The appearance is essentially the same as the original condition. Worse- The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated") Right Arm Left Arm Not Treated Not Treated
    Time Frame
    Day 30, Day 60, Day 90, Day 110
    Secondary Outcome Measure Information:
    Title
    Subject Global Aesthetic Improvement Scale (SGAIS)
    Description
    Subject Global Aesthetic Improvement Scale Assessment How would you rate the overall change in appearance of your treated areas? Non-treated areas will be checked as "Not Treated" for you. Rating Description Very Much Improved- Optimal cosmetic result in this subject Much Improved- Marked improvement in appearance form the initial condition, but not completely optimal for this subject. Improved- Obvious improvement in appearance from initial condition, but a re-treatment is indicated. No Change- The appearance is essentially the same as the original condition. Worse- The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated") Right Arm Left Arm Not Treated Not Treated
    Time Frame
    Day 30, Day 60, Day 90, Day 110

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult males and females aged 18 or older with clinical diagnosis of KP of the posterior upper arms. Subjects in good general health based on investigator's judgment and medical history Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study Understands and accepts the obligation and is logistically able to be present for all visits Is willing to comply with all requirements of the study and sign the informed consent documents Must be willing to maintain usual sun exposure for the duration of the study Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study Subject agrees to avoid any changes in current skincare regimen. Negative urine pregnancy test result at the time of study entry (if applicable) For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment. A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active. Exclusion Criteria: Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study The subject is hypersensitive to light in the visible and/or near infrared wavelength region The subject is taking medication which is known to increase sensitivity to sunlight The subject has a seizure disorder triggered by light The subject has a pacemaker The subject has a metal implant that interferes with the transmission of energy to the electrical field The subject has any embedded electronic devices that give or receive a signal such as Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant Gold or metal allergy The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area or a neuropathic disorder The subject has used topical keratolytics, retinoids, chemical or mechanical exfoliative treatments in the 30 days prior to application of study treatment Dermal fillers, biostimulators, laser treatments, or other energy-based light treatments during the 6-month period before study treatment Subjects with tattoos in the treatment areas Subjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, neoplasm of uncertain behavior, or untreated keratinocyte carcinoma/melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters History of keloid or hypertrophic scarring Subjects with an active bacterial, viral, or fungal infection of the treatment areas The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator Presence of incompletely healed wound(s) in the treatment area Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrea Pacheco
    Phone
    8586571004
    Email
    apacheco@clderm.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sherif Mikhail, MD
    Phone
    8586571004
    Email
    smikhail@westderm.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Laser to Aid in Treatment of Keratosis Pilaris on Arms

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