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CompletedNCT03946826Updated May 14, 2019

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

An interventional study of Halometasone Cream and Vaseline in Nail Psoriasis, sponsored by xjpfW. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-05-14.

Sponsored by xjpfW · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Aug 2015, registered May 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

  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.
02

Conditions studied

  • Nail Psoriasis

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Keywords

  • nail psoriasis
  • Pulsed dye laser (PDL)
  • Halometasone Cream
  • Vaseline
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 20 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

xjpfW is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • 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 · Radiation: Pulsed dye laser (PDL)

  • 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

    Drug: Vaseline · Radiation: Pulsed dye laser (PDL)

  • 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

  • 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

Interventions

  • DrugHalometasone 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

  • DrugVaseline

    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

  • RadiationPulsed 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

06

What researchers measure

Primary outcomes

  1. NAPSI score

    1. 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. 2. 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. 3. 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 outcomes

  1. VAS Pain Assessment

    VAS Pain Assessment,Immediately after Treatment

    Time frame: Change from Baseline to 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03946826
Lead sponsor
xjpfW
Collaborators
Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences
Responsible party
xjpfW (Head of Dermatology, Xijing Hospital) — Sponsor-investigator
First posted
May 13, 2019
Start date
Aug 1, 2015
Primary completion
Aug 1, 2017
Completion
Aug 1, 2017
Last update
May 14, 2019

Study contacts

Wang Gang, Prof
principal investigator · Dermatology Derpartment of Xijing Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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