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