Psoriatic NailNCT01303185
Pulsed Dye Laser for the Psoriatic Nail
An observational study of Psoriatic Nail, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Psoriatic Nail
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Psoriatic nail patients
Who may be able to join
- Psoriatic nail refractory to other topical and systemic treatment therapy
- ≧ 16 years old
Who cannot join
- Patient with pregnancy
- Patient with photo sensitivity
- Patient with severe wound around finger nails or paronychia
- Patient with hypersensitivity to Tazarotene cream
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Psoriatic Nail
- Keywords
- Psoriatic Nail, Pulsed dye laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Not described | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAPSI
Measured: 3rd and 6th months
global physician assessment
Measured: 3rd and 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic NailStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying-Yi Chiang, Taipei Medical University WanFang Hospital
- Investigators
- Ying-Yi Chiang, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303185
- Sponsor's protocol ID
- 99074
- Status last verified
- Dec 2014
- First submitted
- 22 Feb 2011
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Dye Laser for the Psoriatic Nail
- ClinicalTrials.gov ID
- NCT01303185
- Acronym / sponsor ID
- 99074
- Conditions
- Psoriatic Nail
- Keywords
- Psoriatic Nail, Pulsed dye laser
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Psoriatic nail patients
Key inclusion criteria (2 listed)
- Psoriatic nail refractory to other topical and systemic treatment therapy
- ≧ 16 years old
Key exclusion criteria (4 listed)
- Patient with pregnancy
- Patient with photo sensitivity
- Patient with severe wound around finger nails or paronychia
- Patient with hypersensitivity to Tazarotene cream
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NAPSI
Time frame: 3rd and 6th months
global physician assessment
Time frame: 3rd and 6th months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Yi Chiang principal investigator
Taipei Medical University WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Nail, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NAPSI (time frame: 3rd and 6th months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014; AzTrials last refreshed its copy on 1 Nov 2026.