Nail Psoriasis Clinical Trial
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
Verified date | May 2019 |
Source | Xijing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 1, 2017 |
Est. primary completion date | August 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
xjpfW | Air Force General Hospital of the PLA, Chinese Academy of Medical Sciences, First Hospital of China Medical University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | VAS Pain Assessment | VAS Pain Assessment,Immediately after Treatment | Change from Baseline to 6 months |
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