Pulsed Dye Laser for the Psoriatic Nail | NCT01303185

Studies
Pulsed Dye Laser for the Psoriatic Nail

NCT01303185

Sponsor

Taipei Medical University WanFang Hospital

Status

Completed

Last Update Posted

Dec 12, 2014Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Psoriatic Nail

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Feb 22, 2011

First Submission Date that Met QC Criteria

Feb 23, 2011

First Posted Date

Feb 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2014

Last Update Posted Date

Dec 12, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ying-Yi Chiang, Attending Physician, Taipei Medical University WanFang HospitalPrincipal Investigator

Lead Sponsor

Taipei Medical University WanFang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The treatment options for nail psoriasis have been limited, and the management of nail psoriasis has been challenging for physicians.To evaluate the effect of pulsed dye laser (PDL) in the treatment of nail psoriasis.

Detailed Description

Psoriatic nails of patient's right hand were treated using PDL (595 nm) .The pulsed duration is 1.5ms, the beam diameter is 7mm, and the laser energy is 8.0 to 10.0 J/cm2. The treatment course of pulse dye laser is once monthly for 6 months. Psoriatic nails of both hands are treated with Tazarotene cream for 6 months. Clinical efficacy is statistically evaluated according to Nail Psoriasis Severity Index (NAPSI) score differences between right and left hand one month after 3rd and 6th therapy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NAPSI		3rd and 6th months
global physician assessment		3rd and 6th months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Psoriatic nail refractory to other topical and systemic treatment therapy
≧ 16 years old

Exclusion Criteria:

Patient with pregnancy
Patient with photo sensitivity
Patient with severe wound around finger nails or paronychia
Patient with hypersensitivity to Tazarotene cream

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Psoriatic nail patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ying-Yi Chiang	Taipei Medical University WanFang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Medical University - WanFang Hospital		Taipei			Taiwan

Label	Type	Description	Intervention Names
Experimental Group
Control Group