NCT05415839

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

June 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

January 7, 2022

Last Update Submit

June 8, 2022

Conditions

the Efficacy of Fractional Co2 Laser in Nail Psoriais

Outcome Measures

Primary Outcomes (1)

  • Nail psoriasis index (NAPSI)

    change rom baseline at 3 months

Secondary Outcomes (1)

  • diameter of vessels by dermoscopy

    change from baseline at 3 months

Study Arms (2)

Pulsed dye laser

ACTIVE COMPARATOR

Laser device

Device: Laser

Fractional CO2

ACTIVE COMPARATOR

Laser Device

Device: Laser

Interventions

LaserDEVICE

Laser

Fractional CO2Pulsed dye laser

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients with proven onychomycosis by the microscopic mount of nail scraping
  • Patients with excessive manual work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 7, 2022

First Posted

June 13, 2022

Study Start

June 25, 2022

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

June 13, 2022

Record last verified: 2022-06