Protocol summary

Study aim
Efficacy and safety of Pulsed Dye, Neodymium-Doped Yttrium Aluminum Garnet, Fractional CO2 Lasers compared to Betamethasone/Calcipotriol topical ointment in the treatment of nail psoriasis
Design
Interventional, randomized clinical trial with a control group, with parallel groups, block randomized, phase 2 on 40 patients
Settings and conduct
40 patients randomly underwent 3 treatments with Nd:YAG 1064-nm lasers, Pulsed Dye Laser or Fractional CO2 Laser with 3-week intervals in the Razi hospital, Tehran University of Medical Sciences and all patients are treated daily with betamethasone/calcipotriol topical ointment. Follow-up of patients will be done based on the level of satisfaction of two dermatologists with the improvement of patients based on the nail psoriasis severity index.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adults between 18 and 65 years old with psoriasis, mild to moderate bilateral involvement of nails with negative smear and negative culture for onychomycosis. Exclusion criteria: pregnancy and breastfeeding, use of local and systemic treatments during the last 3 months, severe disease requiring systemic treatments, erythrodermic, pustular or drug related psoriasis, severe joint involvement, active bacterial or viral infection in treatment area, history of skin cancers, uncontrolled systemic disease, photosensitivity, history of seizures, history of hypertrophic and keloid scars, hematoma or subungual nevus, and history of nail trauma in the past 3 months
Intervention groups
3 intervention groups treated with Pulsed Dye Laser (VBeam Perfecta Candela), Nd:YAG 1064-nm (Candela Gentle Pro Max) and Fractional CO2 Laser (Edge One, Jeisys) every 3 weeks and all 4 study groups treated with betamethasone/calcipotriol topical ointment
Main outcome variables
Nail Psoriasis Severity Index based on 32 and 8 points "Nail Psoriasis Severity Index"

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220723055530N4
Registration date: 2024-08-14, 1403/05/24
Registration timing: prospective

Last update: 2024-08-14, 1403/05/24
Update count: 0
Registration date
2024-08-14, 1403/05/24
Registrant information
Name
Amirhooshang Ehsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 0223
Email address
ehsanih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of Pulsed Dye, Neodymium-Doped Yttrium Aluminum Garnet, Fractional CO2 Lasers compared to Betamethasone/Calcipotriol topical ointment in the treatment of nail psoriasis
Public title
Effect of Pulsed Dye, Neodymium-Doped Yttrium Aluminum Garnet, Fractional CO2 lasers on nail psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults between 18 and 65 years old Complying with study protocols and signing informed consent voluntarily Enthusiastic people and having the right cooperation for the next follow-up Psoriasis patients with mild to moderate bilateral nail involvement Negative smear and negative culture for onychomycosis
Exclusion criteria:
Pregnancy and breastfeeding Using local and systemic treatments to treat any type of psoriasis during the last 3 months Patients who need systemic treatments due to the severity of the disease Suffering from erythrodermic, pustular or medicinal psoriasis Severe joint involvement that requires systemic treatment Patients with active bacterial or viral infection in the treatment area History of skin cancers Uncontrolled systemic disease Photosensitivity History of seizure History of hypertrophic scars and keloid Presence of hematoma or subungual nevus History of nail trauma in the last 3 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The research population includes patients who are referred to the Razi Skin Hospital of Tehran University of Medical Sciences with a definitive diagnosis of psoriasis, and the NAPSI criteria have been recorded for all their affected nails. Patients will be placed in four groups randomly and through the block randomization method, and based on this grouping, they will receive the required treatment during different follow-up periods. These people are randomly treated 3 times with Nd:YAG 1064-nm lasers (Candela Gentle Max Pro), Pulsed Dye Laser (VBeam Perfecta Candela), Fractional CO2 Laser (Edge One, Jeisys) with 4-week intervals and a A group of patients are also treated daily with betamethasone/calcipotriol topical ointment. Random allocation of patients to group A (Nd:YAG 1064-nm (Candela Gentle Max Pro)), group B (Pulsed Dye Laser (VBeam Perfecta Candela)), group C (Fractional CO2 Laser (Edge One, Jeisys)) and group D (local treatment) is done through block randomization method. To prepare a random list, the table of random numbers is used in such a way that a random number is generated at each stage. If the generated number was 1 or 2, patients will receive group A treatment (Nd:YAG 1064-nm (Candela Gentle Max Pro)), if the generated number was 3 or 4, patients will receive group B treatment (Pulsed Dye Laser ( VBeam Perfecta Candela)), if the generated number was 5 or 6, patients will receive treatment group C (Fractional CO2 Laser (Edge One, Jeisys)), and if the generated number was 7 or 8, patients will receive treatment group (local therapy). Therefore, we repeat this process many times until eligible patients enter the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Room 105, 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.710

Health conditions studied

1

Description of health condition studied
Nail Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis

Primary outcomes

1

Description
Nail Psoriasis Severity Index
Timepoint
Before the intervention, immediately after and one month after the last treatment session
Method of measurement
32 and 8 points "Nail Psoriasis Severity Index"

Secondary outcomes

1

Description
Nail psoriasis severity index based on matrix area score
Timepoint
Before the intervention, immediately after and one month after the last treatment session
Method of measurement
Based on the formation of pitting, leukonychia, red spots in the lunula, crumbling in the nail

2

Description
Nail psoriasis severity index based on the nail bed area score
Timepoint
Before the intervention, immediately after and one month after the last treatment session
Method of measurement
Based on the formation of onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma) in the nail

Intervention groups

1

Description
First intervention group: treated with Pulsed Dye Laser (VBeam Perfecta Candela) every 3 weeks plus daily treatment with betamethasone/calcipotriol topical ointment in the matrix area and nail bed
Category
Treatment - Devices

2

Description
The second intervention group: treated with Nd:YAG 1064-nm laser (Candela Gentle Pro Max) every 3 weeks plus daily treatment with betamethasone/calcipotriol topical ointment in the matrix area and nail bed
Category
Treatment - Devices

3

Description
The third intervention group: treated with Fractional CO2 Laser (Edge One, Jeisys) every 3 weeks plus daily treatment with betamethasone/calcipotriol topical ointment in the matrix area and nail bed
Category
Treatment - Devices

4

Description
Control group: Treated daily with betamethasone/calcipotriol topical ointment in the matrix and nail bed area
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology clinic of Razi Hospital
Full name of responsible person
Amirhooshang Ehsani
Street address
Razi Hospital, Vahdateeslami St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0705
Fax
Email
ehsanih@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhooshang Ehsani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Vahdat Eslami Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0705
Email
ehsanih@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhooshang Ehsani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Vahdat Eslami Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0705
Fax
Email
ehsanih@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhooshang Ehsani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Vahdat Eslami Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0705
Fax
Email
ehsanih@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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