the Efficacy of Fractional Co2 Laser in Nail PsoriaisNCT05415839
Fractional CO2 Laser Versus Pulsed Dye Laser in Nail Psoriasis
A study testing Laser in people with the Efficacy of Fractional Co2 Laser in Nail Psoriais, run by Cairo University.
Trial summary
The aim of this work is to assess the efficacy and safety of fractional CO2 laser therapy in comparison to pulsed dye laser (PDL) in the treatment of nail psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- the Efficacy of Fractional Co2 Laser in Nail Psoriais
- What is being tested?
- Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2022to 15 Sep 2022
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - All patients with bilateral nail psoriasis.
- Age: Above 18
- Sex: both sexes
Who cannot join
- - Cases who received treatment (systemic or topical) in the last 3 months before inclusion.
- Patients with proven onychomycosis by the microscopic mount of nail scraping
- Patients with excessive manual work
About this study
Official title: Efficacy of Fractional CO2 Laser Versus Pulsed Dye Laser in the Treatment of Fingernail Psoriasis, a Randomized Controlled Trial.
The aim of this work is to assess the efficacy and safety of fractional CO2 laser therapy in comparison to pulsed dye laser (PDL) in the treatment of nail psoriasis.
Read the detailed description
Study Design:
Randomized Clinical Trial
- Inclusion criteria:
- All patients with bilateral nail psoriasis.
- Age: Above 18
- Sex: both sexes
- Exclusion criteria:
- Cases who received treatment (systemic or topical) in the last 3 months before inclusion.
- Patients with proven onychomycosis by the microscopic mount of nail scraping
- Patients with excessive manual work
- Methodology in detail:
- All patients will be given written informed consent to participate in this study, children's parents are to sign their consent.
- Intra-patient randomization of 30 patients will be done so that the nails of each hand will be randomly included in one of two groups:
- Group A: The patient will receive 3 sessions of 1 month in-between of fractional CO2 laser with the following parameters: Two passes of 15 J, stacking 2, dwell time 500 Us, spacing 300 Um
- Group B: The patient will receive 3 sessions of pulsed dye laser of 1 month in-between with the following parameters: Two passes of 7 mm handpiece, 7.5 J, 0.5 msec pulse duration.
- Assessment will be carried as follows:
- Full medical history of the disease and associated DM, HTN, or other systemic diseases.
- Nail scrapping will be don by 30% KOH solution to exclude onychomycosis.
- Clinical assessment by nail psoriasis index (NAPSI) (11) before treatment, 1 month and 3 months after the last session.
- Photography before treatment, before each session of laser together with 1 month after the last session, and after 3 months of follow-up, photos will be examined by 2 blinded investigators.
- Onychoscopic assessment will be done before treatment and after 1 month of the last session together with after 3 months follow up.
- Capillorscopy of the proximal nail fold will be done before treatment and after 1 month of the last session together with after 3 months follow up.
- Nail psoriasis quality of life scale (NPQ10) (12). will be done at the first visit, 1 month after the last session together with after 3 months follow up.
- Visual analog scale (VAS) will be used to assess the pain of laser sessions.
- Patient satisfaction will be reported at the end of the study by patient satisfaction score (excellent, very good, good, bad, very bad).
- Primary outcomes (Most important measurable outcomes)
- Assessment of the efficacy of fractional CO2 laser in the treatment of nail psoriasis clinically by photography and NAPSI score
- Comparing the safety and efficacy of fractional CO2 laser to the main type of laser used in nail psoriasis; PDL
- Secondary outcome parameters (other outcomes to be assessed)
- Onychoscopic assessment of the efficacy of fractional laser in treating nail psoriasis
- Determining the effect of fractional CO2 laser on both nail matrix and nail bed signs
- Capillorscopic assessment of both PDL and fractional CO2 laser on nail psoriasis
- Being tested
- Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
Laser
| Study group | Role | What they receive |
|---|---|---|
| Pulsed dye laser | Active comparator | Laser device Receives: Device: Laser |
| Fractional CO2 | Active comparator | Laser Device Receives: Device: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nail psoriasis index (NAPSI)
Measured: change rom baseline at 3 months
Secondary outcomes (1)
diameter of vessels by dermoscopy
Measured: change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start25 Jun 2022 (estimated)
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Efficacy of Fractional Co2 Laser in Nail PsoriaisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar El Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415839
- Sponsor's protocol ID
- Laser in nail psoriasis
- Status last verified
- Jun 2022
- First submitted
- 7 Jan 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fractional CO2 Laser Versus Pulsed Dye Laser in the Treatment of Fingernail Psoriasis, a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05415839
- Acronym / sponsor ID
- Laser in nail psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jun 2022 (estimated)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 13 Jun 2022 (actual)
- 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 aim of this work is to assess the efficacy and safety of fractional CO2 laser therapy in comparison to pulsed dye laser (PDL) in the treatment of nail psoriasis.
Detailed description
Study Design:
Randomized Clinical Trial
- Inclusion criteria:
- All patients with bilateral nail psoriasis.
- Age: Above 18
- Sex: both sexes
- Exclusion criteria:
- Cases who received treatment (systemic or topical) in the last 3 months before inclusion.
- Patients with proven onychomycosis by the microscopic mount of nail scraping
- Patients with excessive manual work
- Methodology in detail:
- All patients will be given written informed consent to participate in this study, children's parents are to sign their consent.
- Intra-patient randomization of 30 patients will be done so that the nails of each hand will be randomly included in one of two groups:
- Group A: The patient will receive 3 sessions of 1 month in-between of fractional CO2 laser with the following parameters: Two passes of 15 J, stacking 2, dwell time 500 Us, spacing 300 Um
- Group B: The patient will receive 3 sessions of pulsed dye laser of 1 month in-between with the following parameters: Two passes of 7 mm handpiece, 7.5 J, 0.5 msec pulse duration.
- Assessment will be carried as follows:
- Full medical history of the disease and associated DM, HTN, or other systemic diseases.
- Nail scrapping will be don by 30% KOH solution to exclude onychomycosis.
- Clinical assessment by nail psoriasis index (NAPSI) (11) before treatment, 1 month and 3 months after the last session.
- Photography before treatment, before each session of laser together with 1 month after the last session, and after 3 months of follow-up, photos will be examined by 2 blinded investigators.
- Onychoscopic assessment will be done before treatment and after 1 month of the last session together with after 3 months follow up.
- Capillorscopy of the proximal nail fold will be done before treatment and after 1 month of the last session together with after 3 months follow up.
- Nail psoriasis quality of life scale (NPQ10) (12). will be done at the first visit, 1 month after the last session together with after 3 months follow up.
- Visual analog scale (VAS) will be used to assess the pain of laser sessions.
- Patient satisfaction will be reported at the end of the study by patient satisfaction score (excellent, very good, good, bad, very bad).
- Primary outcomes (Most important measurable outcomes)
- Assessment of the efficacy of fractional CO2 laser in the treatment of nail psoriasis clinically by photography and NAPSI score
- Comparing the safety and efficacy of fractional CO2 laser to the main type of laser used in nail psoriasis; PDL
- Secondary outcome parameters (other outcomes to be assessed)
- Onychoscopic assessment of the efficacy of fractional laser in treating nail psoriasis
- Determining the effect of fractional CO2 laser on both nail matrix and nail bed signs
- Capillorscopic assessment of both PDL and fractional CO2 laser on nail psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed dye laser | Active comparator | Device: LaserLaser device |
| Fractional CO2 | Active comparator | Device: LaserLaser Device |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- - All patients with bilateral nail psoriasis.
- Age: Above 18
- Sex: both sexes
Key exclusion criteria (3 listed)
- - Cases who received treatment (systemic or topical) in the last 3 months before inclusion.
- Patients with proven onychomycosis by the microscopic mount of nail scraping
- Patients with excessive manual work
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaserLaser | Device | Fractional CO2, Pulsed dye laser |
Primary outcome
Nail psoriasis index (NAPSI)
Time frame: change rom baseline at 3 months
1 secondary outcome
diameter of vessels by dermoscopy
Time frame: change from baseline at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laser in people with the Efficacy of Fractional Co2 Laser in Nail Psoriais, run by Cairo University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Nail psoriasis index (NAPSI) (time frame: change rom baseline at 3 months). 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 13 Jun 2022.