The aim to the study is to compare the effectiveness of fractionated resurfacing carbon dioxide LASER and topical methotrexate with topical PUVASOL in cases of vitiligo effecting less than 10% body surface area.
Design
Two arm parallel group randomized control trial with blinded outcome assessment by a neutral assessor
Settings and conduct
The trial will be conducted in dermatology outpatient department of a tertiary care hospital.30 patients will be selected based on inclusion/exclusion criteria. They will be randomized into 2 groups of 15 by allocation concealed randomization in the form of selecting one of the 2 sealed envelopes. Patients and assessor will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients willing to participate in the study; of age group of 10 -70 years; Vitiligo involving less than or equal to 10% body surface area.
Exclusion Criteria: Patients using or have used other treatments for vitiligo; Pregnant women or lactating women; segmental vitiligo; Patients on immunosuppressant medications; Patients having contraindication to methotrexate or PUVASOL.
Intervention groups
For Group A, a 10,600-nm fractional carbon dioxide laser device will be used with a resurfacing mode followed by topical methotrexate application. 3 sessions will be done at 2weeks a part interval.
Group B will be advised topical psoralen i.e. Methoxsalen .5% ointment is to be applied for 45 minutes on the vitiligous patch prior to sunlight exposure followed by photo exposure for 5 to 10 minutes. Patients will be examined monthly for 2 months.
Effectiveness Of Fractional Carbon dioxide LASER with Topical Methotrexate Vs Topical PUVASOL in Treatment of Vitiligo-RCT
Public title
Fractional Carbon dioxide LASER with Topical Methotrexate Vs Topical PUVASOL in Treatment of Vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients willing to participate in the study
Patients of age group 10 -70 years.
Vitiligo involving less than or equal to 10% body surface area.
Exclusion criteria:
Patients using or have used other treatments for vitiligo in the recent past
Pregnant women or lactating women
Patients with segmental vitiligo
Patients on immunosuppressant medications due to other diseases
Patients having connective tissue diseases, epilepsy or photosensitivity disorders
Patient having previous radiotherapy or phototherapy.
Patients with personal or family history of melanoma and non-melanoma skin cancers
Patients having contraindications to methotrexate or PUVASOL therapy
Age
From 10 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be used to divide the study sample into two groups .Unit of randomization will be individual with the help of giving random sealed envelope to the patients. Allocation concealment will be carried out.
Blinding (investigator's opinion)
Double blinded
Blinding description
Besides principal investigator and her assistant, no one in the study i.e. Patients or the neutral assessor will know about the treatment modality used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitee Pak Emirates Hospital Rawalpindi
Street address
Saddar,Rawalpindi
City
Rawalpindi
Postal code
44000
Approval date
2024-02-21, 1402/12/02
Ethics committee reference number
A/28/ERC/O3/2024
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
clinical improvement
Timepoint
At the end of 1st and 2nd month
Method of measurement
A blinded independent medical observer will perform clinical assessments using the following grading scale for all 30 patients: 1, < 25% minimal re-pigmentation; 2, 26–50% mild re-pigmentation; 3, 51–75% moderate re-pigmentation; 4, >75% excellent re-pigmentation.
2
Description
Patient satisfaction
Timepoint
At the end of 1st and 2nd month
Method of measurement
Patient satisfaction will also be assessed by grading scale i.e. 1. Unsatisfied, 2. Partially satisfied, 3. Completely satisfied.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Fractional Carbon dioxide laser followed by topical methotrexate. Topical eutectic mixture of local anesthetic cream will be applied over the patient’s lesions for 30- 45 min. A 10,600-nm fractional carbon dioxide (CO2) laser device will be used. Key laser parameters included will be; a resurfacing mode, pulse energy of 70–100 J/cm2, coverage and a spot density of 150 spots/cm2 (static mode). After each session topical 25mg/ml methotrexate injection, not more than 0.3 ml will be massaged on the treated area and allowed to air dry. Patient will be given methotrexate to apply as few drops on the affected area once daily for 3 days after procedure. 4 sessions were done at 2weeks a part. Patients will be examined monthly for 2 months for assessment of re-pigmentation.
Category
Treatment - Other
2
Description
Intervention group 2: Topical PUVASOL. People in this Group will be advised topical psoralen with the name of Lukodermine by Howards Pharma. The ointment contains Methoxsalen as its active ingredient and comes in a pack size of 30gm .5% ointment is to be applied for 45 minutes on the vitiligous patch prior to sunlight exposure. Initially photo exposure will be done for 3 minutes and then incrementally increased by 30 seconds every time until a moderate persistent erythema or maximal exposure time of 10 minutes will be achieved. This treatment will be done thrice a week. Treated area will be washed with soap and water and sunscreen will be applied with the spf of 60 or more. Patients will be examined monthly for 2 months for assessment of re-pigmentation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology OPD of Pak Emirates Hospital Rawalpindi
Full name of responsible person
Dr. Sakina Sadiq Malik
Street address
Saddar,Rawalpindi
City
Rawalpindi
Postal code
44000
Phone
+92 321 5108737
Email
dazzlingdocsak2078@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National University of Medical Sciences
Full name of responsible person
Sakina Sadiq Malik
Street address
Saddar,Rawalpindi
City
Rawalpindi
Postal code
44000
Phone
+92 321 5108737
Email
dazzlingdocsak2078@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
NUMS-Pakistan
Full name of responsible person
Sakina Sadiq Malik
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Saddar,Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
44000
Phone
+92 321 5108737
Email
dazzlingdocsak2078@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
NUMS-Pakistan
Full name of responsible person
Sakina Sadiq Malik
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Saddar,Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
44000
Phone
+92 321 5108737
Email
dazzlingdocsak2078@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
National University of Medical Sciences
Full name of responsible person
Sakina Sadiq Malik
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Saddar,Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
44000
Phone
+92 321 5108737
Email
dazzlingdocsak2078@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
EFFECTIVENESS OF FRACTIONAL CARBONDIOXIDE LASER WITH TOPICAL METHOTREXATE VS TOPICAL PUVASOL IN TREATEMENT OF VITILIGO-RCT
When the data will become available and for how long
After publication and will be available through research gate indefinitely
To whom data/document is available
It will be open access.
Under which criteria data/document could be used
Will depend on publishing jiurnal policy
From where data/document is obtainable
Research gate, Journals website
What processes are involved for a request to access data/document