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Fractional CO2 Laser Versus Pulsed Dye Laser in Nail Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05415839
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Cairo University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 the Efficacy of Fractional Co2 Laser in Nail Psoriais
Additional Details

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: 1.
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. 2. 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) 1.
Assessment of the efficacy of fractional CO2 laser in the treatment of nail psoriasis clinically by photography and NAPSI score. 2. 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) 1.
Onychoscopic assessment of the efficacy of fractional laser in treating nail psoriasis. 2. Determining the effect of fractional CO2 laser on both nail matrix and nail bed signs. 3. Capillorscopic assessment of both PDL and fractional CO2 laser on nail psoriasis

Arms & Interventions

Arms

Active Comparator: Pulsed dye laser

Laser device

Active Comparator: Fractional CO2

Laser Device

Interventions

Device: - Laser

Laser

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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