Fractional CO2 Laser Versus Pulsed Dye Laser in Nail Psoriasis

Efficacy of Fractional CO2 Laser Versus Pulsed Dye Laser in the Treatment of Fingernail Psoriasis, a Randomized Controlled Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: the Efficacy of Fractional Co2 Laser in Nail Psoriais
• Intervention / Treatment: Device: Laser

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:

  1. 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
  2. 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)

  1. Assessment of the efficacy of fractional CO2 laser in the treatment of nail psoriasis clinically by photography and NAPSI score
  2. 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)

  1. Onychoscopic assessment of the efficacy of fractional laser in treating nail psoriasis
  2. Determining the effect of fractional CO2 laser on both nail matrix and nail bed signs
  3. Capillorscopic assessment of both PDL and fractional CO2 laser on nail psoriasis

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pulsed dye laser; Laser device	Device: Laser; Laser
Active Comparator: Fractional CO2; Laser Device	Device: Laser; Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Nail psoriasis index (NAPSI)	change rom baseline at 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
diameter of vessels by dermoscopy	change from baseline at 3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 25, 2022
• Primary Completion (Anticipated): September 15, 2022
• Study Completion (Anticipated): September 15, 2022

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: Laser in nail psoriasis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No