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

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

1. 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.
2. Pulsed dye laser (PDL) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis
3. 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.
4. 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.

Study Overview

• Status: Completed
• Conditions: Nail Psoriasis
• Intervention / Treatment: Drug: Halometasone Cream; Radiation: Pulsed dye laser (PDL); Drug: Vaseline

• Study Type: Interventional
• Enrollment (Actual): 20
• 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:

.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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PDL+ Halometasone Cream group; 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	Drug: Halometasone Cream; 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; Radiation: Pulsed dye laser (PDL); 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
Experimental: PDL+Vaseline group; 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	Radiation: Pulsed dye laser (PDL); 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; Drug: Vaseline; 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
Active Comparator: Halometasone Cream; 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	Drug: Halometasone Cream; 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
Placebo Comparator: Vaseline; 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	Drug: Vaseline; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Pain Assessment	VAS Pain Assessment，Immediately after Treatment	Change from Baseline to 6 months

Collaborators and Investigators

• Sponsor: xjpfW
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; First Hospital of China Medical University; Air Force General Hospital of the PLA
• Investigators: Principal Investigator: Wang Gang, Prof, Dermatology Derpartment of Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 11, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: nail psoriasis; Pulsed dye laser (PDL); Halometasone Cream; Vaseline
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Emollients; Petrolatum; Halometasone
• Other Study ID Numbers: XJPFMR-20150707

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No