search
Back to results

A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser (PDL) in the Treatment of Nail Psoriasis

Primary Purpose

Nail Psoriasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Halometasone Cream
Vaseline
Pulsed dye laser (PDL)
Sponsored by
xjpfW
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nail Psoriasis focused on measuring nail psoriasis, Pulsed dye laser (PDL), Halometasone Cream, Vaseline

Eligibility Criteria

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

Inclusion Criteria:

.subjects must be clinically diagnosed by the investigator to have nail psoriasis .All nails have psoriasis on both hand.Males or females, 18 Years to 65 Years of age at the time of signing the informed consent document.

.No other external treatment was performed before the injury was treated. .The condition of no rupture or infection in the skin affected the field of vision of laser operation.

.The patient has no history of treatment of biological preparations, such as Indolisimab, etc.

.Check blood routine, liver and kidney function, normal blood sugar, female urine pregnancy test negative during childbearing age.

.Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.

Exclusion Criteria:

  • Pregnant or lactating women with a history of light sensitivity;
  • The patient has just stopped or started new systemic treatment; Patients with serious infectious diseases;
  • suffering from severe diabetes, severe cardiovascular disease and connective tissue disease;
  • patients with a history of active tuberculosis, blood diseases, and epilepsy;
  • There are infected persons and patients with acute infectious diseases in the treatment site;
  • Patients who are considered by the researchers to be unfit to participate in this experiment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    PDL+ Halometasone Cream group

    PDL+Vaseline group

    Halometasone Cream

    Vaseline

    Arm Description

    PDL+ Halometasone Cream Halometasone Cream, bid ,external use for 6 months; 3 nails were randomly selected to be treated with PDL laser therapy (6ms, 11±2J/cm2) once a month for a total of 6 times

    PDL+Vaseline Vaseline, bid ,external use for 6 months; 3 nails were randomly selected to be treated with PDL laser therapy (6ms, 11±2J/cm2) once a month for a total of 6 times

    Halometasone is a potent halogen - containing topical glucocorticoid. Have stronger fight inflammation, fight allergy, contractive hemal, reduce hemal to connect the action of permeability and fight hyperplasia

    Vaseline belongs to a kind of mineral wax, without irritant, not easy to deteriorate, can let skin surface form a protective film when used on the skin, let the moisture of the skin be evaporated not easily, have better protect wet effect

    Outcomes

    Primary Outcome Measures

    NAPSI score
    Nail matrix score: according to the proportion of nail matrix damage (puncture, meniscus with all white and red spots, and nail fragmentation) to the nail matrix content, 0 means no, 1 means 1/4 nail, 2 means 2/4 nail, 3 means cumulative 3/4 nail, and 4 means total nail. Nail bed score: the nail bed damage (nail dissection, puncture hemorrhage, hyperkeratosis under the nail, salmon spot) is graded according to the proportion of the nail bed. 0 means no, 1 means 1/4 nail, 2 means 2/4 nail, 3 means cumulative 3/4 nail, and 4 means total nail. Single nail score is the sum of nail matrix score and nail bed score (0-8 points), The final score is the sum of all single nail scores (0-80), and the nail score can be conducted at any time as required.

    Secondary Outcome Measures

    VAS Pain Assessment
    VAS Pain Assessment,Immediately after Treatment

    Full Information

    First Posted
    May 10, 2019
    Last Updated
    May 11, 2019
    Sponsor
    xjpfW
    Collaborators
    Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03946826
    Brief Title
    A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser (PDL) in the Treatment of Nail Psoriasis
    Official Title
    A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser (PDL) in the Treatment of Nail Psoriasis: a Single-blind, Randomized, Self-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2015 (Actual)
    Primary Completion Date
    August 1, 2017 (Actual)
    Study Completion Date
    August 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    xjpfW
    Collaborators
    Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Psoriasis is a common chronic, inflammatory disease characterized by skin changes and joint involvement. About 50% of patients with psoriasis have damage to the nail, especially in pustular psoriasis in the continuous acromegaly dermatitis. Common damage includes pitting, uneven and tarnish of the deck, as well as the occurrence of nail ridges, furrows, turbidity, hypertrophy, free ends and nail bed stripping, and even the whole deck deformity or absence, etc., seriously affecting patients' social interaction and mental health. Pathologically, telangiectasis is associated with the superficial and middle layers of the dermis. Previous treatment of psoriasis nail is mainly topical drugs (such as glucocorticoid, etc.), but due to its long disease period, topical drugs are difficult to transdermal absorption, and the curative effect of skin lesions is poor. Pulsed dye laser (PDL) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis It has been reported that PDL is effective in the treatment of psoriasis vulgis by blocking the nutrient supply vessels of the lesions, improving the surrounding microenvironment, reducing the number of cytotoxic T cells and helper T cells in the dermis, and promoting the normalization of epidermal proliferation and differentiation. Halometasone is a potent halogen - containing topical glucocorticoid. Have stronger fight inflammation, fight allergy, contractive hemal, reduce hemal to connect the action of permeability and fight hyperplasia Vaseline belongs to a kind of mineral wax, without irritant, not easy to deteriorate, can let skin surface form a protective film when used on the skin, let the moisture of the skin be evaporated not easily, have better protect wet effect.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nail Psoriasis
    Keywords
    nail psoriasis, Pulsed dye laser (PDL), Halometasone Cream, Vaseline

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PDL+ Halometasone Cream group
    Arm Type
    Experimental
    Arm Description
    PDL+ Halometasone Cream Halometasone Cream, bid ,external use for 6 months; 3 nails were randomly selected to be treated with PDL laser therapy (6ms, 11±2J/cm2) once a month for a total of 6 times
    Arm Title
    PDL+Vaseline group
    Arm Type
    Experimental
    Arm Description
    PDL+Vaseline Vaseline, bid ,external use for 6 months; 3 nails were randomly selected to be treated with PDL laser therapy (6ms, 11±2J/cm2) once a month for a total of 6 times
    Arm Title
    Halometasone Cream
    Arm Type
    Active Comparator
    Arm Description
    Halometasone is a potent halogen - containing topical glucocorticoid. Have stronger fight inflammation, fight allergy, contractive hemal, reduce hemal to connect the action of permeability and fight hyperplasia
    Arm Title
    Vaseline
    Arm Type
    Placebo Comparator
    Arm Description
    Vaseline belongs to a kind of mineral wax, without irritant, not easy to deteriorate, can let skin surface form a protective film when used on the skin, let the moisture of the skin be evaporated not easily, have better protect wet effect
    Intervention Type
    Drug
    Intervention Name(s)
    Halometasone Cream
    Intervention Description
    Halometasone is a potent halogen - containing topical glucocorticoid. Have stronger fight inflammation, fight allergy, contractive hemal, reduce hemal to connect the action of permeability and fight hyperplasia
    Intervention Type
    Drug
    Intervention Name(s)
    Vaseline
    Intervention Description
    Vaseline belongs to a kind of mineral wax, without irritant, not easy to deteriorate, can let skin surface form a protective film when used on the skin, let the moisture of the skin be evaporated not easily, have better protect wet effect
    Intervention Type
    Radiation
    Intervention Name(s)
    Pulsed dye laser (PDL)
    Intervention Description
    Pulsed dye laser (PDL) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis,is effective in the treatment of psoriasis
    Primary Outcome Measure Information:
    Title
    NAPSI score
    Description
    Nail matrix score: according to the proportion of nail matrix damage (puncture, meniscus with all white and red spots, and nail fragmentation) to the nail matrix content, 0 means no, 1 means 1/4 nail, 2 means 2/4 nail, 3 means cumulative 3/4 nail, and 4 means total nail. Nail bed score: the nail bed damage (nail dissection, puncture hemorrhage, hyperkeratosis under the nail, salmon spot) is graded according to the proportion of the nail bed. 0 means no, 1 means 1/4 nail, 2 means 2/4 nail, 3 means cumulative 3/4 nail, and 4 means total nail. Single nail score is the sum of nail matrix score and nail bed score (0-8 points), The final score is the sum of all single nail scores (0-80), and the nail score can be conducted at any time as required.
    Time Frame
    Change from Baseline to 1 year
    Secondary Outcome Measure Information:
    Title
    VAS Pain Assessment
    Description
    VAS Pain Assessment,Immediately after Treatment
    Time Frame
    Change from Baseline to 6 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: .subjects must be clinically diagnosed by the investigator to have nail psoriasis .All nails have psoriasis on both hand.Males or females, 18 Years to 65 Years of age at the time of signing the informed consent document. .No other external treatment was performed before the injury was treated. .The condition of no rupture or infection in the skin affected the field of vision of laser operation. .The patient has no history of treatment of biological preparations, such as Indolisimab, etc. .Check blood routine, liver and kidney function, normal blood sugar, female urine pregnancy test negative during childbearing age. .Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. Exclusion Criteria: Pregnant or lactating women with a history of light sensitivity; The patient has just stopped or started new systemic treatment; Patients with serious infectious diseases; suffering from severe diabetes, severe cardiovascular disease and connective tissue disease; patients with a history of active tuberculosis, blood diseases, and epilepsy; There are infected persons and patients with acute infectious diseases in the treatment site; Patients who are considered by the researchers to be unfit to participate in this experiment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wang Gang, Prof
    Organizational Affiliation
    Dermatology Derpartment of Xijing Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser (PDL) in the Treatment of Nail Psoriasis

    We'll reach out to this number within 24 hrs