search
Back to results

Fractional CO2 Laser Versus Pulsed Dye Laser in Nail Psoriasis

Primary Purpose

the Efficacy of Fractional Co2 Laser in Nail Psoriais

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for the Efficacy of Fractional Co2 Laser in Nail Psoriais

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • - All patients with bilateral nail psoriasis.
  • Age: Above 18
  • Sex: both sexes

Exclusion Criteria:

  • - Cases who received treatment (systemic or topical) in the last 3 months before inclusion.
  • Patients with proven onychomycosis by the microscopic mount of nail scraping
  • Patients with excessive manual work

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Pulsed dye laser

    Fractional CO2

    Arm Description

    Laser device

    Laser Device

    Outcomes

    Primary Outcome Measures

    Nail psoriasis index (NAPSI)

    Secondary Outcome Measures

    diameter of vessels by dermoscopy

    Full Information

    First Posted
    January 7, 2022
    Last Updated
    June 8, 2022
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05415839
    Brief Title
    Fractional CO2 Laser Versus Pulsed Dye Laser in Nail Psoriasis
    Official Title
    Efficacy of Fractional CO2 Laser Versus Pulsed Dye Laser in the Treatment of Fingernail Psoriasis, a Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 25, 2022 (Anticipated)
    Primary Completion Date
    September 15, 2022 (Anticipated)
    Study Completion Date
    September 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this work is to assess the efficacy and safety of fractional CO2 laser therapy in comparison to pulsed dye laser (PDL) in the treatment of nail psoriasis.
    Detailed Description
    Study Design: Randomized Clinical Trial Inclusion criteria: All patients with bilateral nail psoriasis. Age: Above 18 Sex: both sexes Exclusion criteria: Cases who received treatment (systemic or topical) in the last 3 months before inclusion. Patients with proven onychomycosis by the microscopic mount of nail scraping Patients with excessive manual work Methodology in detail: All patients will be given written informed consent to participate in this study, children's parents are to sign their consent. Intra-patient randomization of 30 patients will be done so that the nails of each hand will be randomly included in one of two groups: Group A: The patient will receive 3 sessions of 1 month in-between of fractional CO2 laser with the following parameters: Two passes of 15 J, stacking 2, dwell time 500 Us, spacing 300 Um Group B: The patient will receive 3 sessions of pulsed dye laser of 1 month in-between with the following parameters: Two passes of 7 mm handpiece, 7.5 J, 0.5 msec pulse duration. Assessment will be carried as follows: Full medical history of the disease and associated DM, HTN, or other systemic diseases. Nail scrapping will be don by 30% KOH solution to exclude onychomycosis. Clinical assessment by nail psoriasis index (NAPSI) (11) before treatment, 1 month and 3 months after the last session. Photography before treatment, before each session of laser together with 1 month after the last session, and after 3 months of follow-up, photos will be examined by 2 blinded investigators. Onychoscopic assessment will be done before treatment and after 1 month of the last session together with after 3 months follow up. Capillorscopy of the proximal nail fold will be done before treatment and after 1 month of the last session together with after 3 months follow up. Nail psoriasis quality of life scale (NPQ10) (12). will be done at the first visit, 1 month after the last session together with after 3 months follow up. Visual analog scale (VAS) will be used to assess the pain of laser sessions. Patient satisfaction will be reported at the end of the study by patient satisfaction score (excellent, very good, good, bad, very bad). Primary outcomes (Most important measurable outcomes) Assessment of the efficacy of fractional CO2 laser in the treatment of nail psoriasis clinically by photography and NAPSI score Comparing the safety and efficacy of fractional CO2 laser to the main type of laser used in nail psoriasis; PDL Secondary outcome parameters (other outcomes to be assessed) Onychoscopic assessment of the efficacy of fractional laser in treating nail psoriasis Determining the effect of fractional CO2 laser on both nail matrix and nail bed signs Capillorscopic assessment of both PDL and fractional CO2 laser on nail psoriasis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    the Efficacy of Fractional Co2 Laser in Nail Psoriais

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pulsed dye laser
    Arm Type
    Active Comparator
    Arm Description
    Laser device
    Arm Title
    Fractional CO2
    Arm Type
    Active Comparator
    Arm Description
    Laser Device
    Intervention Type
    Device
    Intervention Name(s)
    Laser
    Intervention Description
    Laser
    Primary Outcome Measure Information:
    Title
    Nail psoriasis index (NAPSI)
    Time Frame
    change rom baseline at 3 months
    Secondary Outcome Measure Information:
    Title
    diameter of vessels by dermoscopy
    Time Frame
    change from baseline at 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - All patients with bilateral nail psoriasis. Age: Above 18 Sex: both sexes Exclusion Criteria: - Cases who received treatment (systemic or topical) in the last 3 months before inclusion. Patients with proven onychomycosis by the microscopic mount of nail scraping Patients with excessive manual work

    12. IPD Sharing Statement

    Learn more about this trial

    Fractional CO2 Laser Versus Pulsed Dye Laser in Nail Psoriasis

    We'll reach out to this number within 24 hrs