Evaluation of the additional effect of 15% TCA peel on response to phototherapy of patients with acral vitiligo
Design
Clinical trial with parallel groups, randomized and single blind, conducted on 40 patients
Settings and conduct
This study will be conducted on 40 patients with acral vitiligo referring to Imam Reza Hospital. Patients are randomly divided into two groups. Size of vitiligo lesions are measured using photography. In the intervention group, for one side of the patient's limb, treatment with 15% TCA peel will be performed once a week for 1 month. Then, after 10 to 15 days, phototherapy will begin twice a week for 6 months, preferably using PUVAbath therapy. For the other side of the patient's limb as the control group, only phototherapy will be performed. At the end of the study, rate of repigmentation of patients’ limbs will be compared before and after intervention and also between opposite limbs based on the photos taken. In this single blind study, only outcome assessors are unaware of the type of groupings.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with acral vitiligo; age is over 12 years. Exclusion criteria: patients with a history of Koebner phenomenon; patients with a history of keloids; pregnancy; photosensitivity
Intervention groups
In the intervention group, for one side of the patient's limbs, treatment with 15% TCA peel will be performed once a week for 1 month. Then, after 10 to 15 days, phototherapy will begin twice a week for 6 months, preferably using PUVAbath therapy. For the opposing side of the patient's limbs as the control group, only phototherapy will be performed.
Main outcome variables
Size of vitiligo lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211024052859N1
Registration date:2022-01-19, 1400/10/29
Registration timing:prospective
Last update:2022-01-19, 1400/10/29
Update count:0
Registration date
2022-01-19, 1400/10/29
Registrant information
Name
Yasaman Rastegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3649 0953
Email address
rastegary971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the additional effect of 15% TCA peel on response to phototherapy of patients with acral vitiligo
Public title
The effect of 15% TCA peel on phototherapy of patients with acral vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acral vitiligo
Age is over 12 years
Exclusion criteria:
Patients with a history of Koebner phenomenon
Patients with a history of keloids
Pregnancy
Photosensitivity
Age
From 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The envelopes will be prepared by one of the members of the research team and the random numbers generated by the ''www.randomization.com'' website will be printed and placed in each envelope. In this website, the number of participants along with the number of groups are entered. Then for each group, a number of codes will be generated randomly. The envelopes are sealed and their contents are not visible from outside. At first, purpose of the study is explained for each participants and after filling out the consent form, each participant selects an envelope and opens it and based on the type of intervention, receives phototherapy and 15% TCA peel for organs of one side as intervention and only phototherapy for the other side of body as control group. Randomization only takes place to select the right or left limb.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study only outcome assessors, when evaluating the patients, will be unaware of how patients are grouped and which treatment they receive. No placebo drug will be used in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-04-13, 1400/01/24
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.276
Health conditions studied
1
Description of health condition studied
acral vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Size of vitiligo lesions
Timepoint
At the beginning of the study and after 6 months of phototherapy
Method of measurement
Images taken before and after the intervention are compared between the two groups after 6 months of phototherapy by two physicians outside the study based on the rate of repigmentation. The ideal response is above 75% repigmentation.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, for one side of the patient's body (either the left or the right limb) which will be determined after randomization, treatment with 15% TCA peel will be performed once a week for 1 month. Then, after 10 to 15 days, phototherapy will begin twice a week for 6 months, preferably using PUVAbath therapy.
Category
Treatment - Drugs
2
Description
Control group: In this group, for the limb opposing the one in the in the intervention group, only phototherapy will begin twice a week for 6 months, preferably using PUVAbath therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Yalda Nahidy
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Email
nahidiy@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Yasaman Rastegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Ghaem hospital, Ahmadabad street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 71 3649 0953
Fax
Email
Rastegary971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Yalda Nahidi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Email
nahidiy@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Yasaman Rastegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Ghaem hospital, Ahmadabad street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 71 3649 0953
Fax
Email
Rastegary971@mums.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data can be accessible through an email to the corresponding author.
Under which criteria data/document could be used
Data will be available for researchers in universities and other scientific institutes.
From where data/document is obtainable
After sending a request email to the corresponding author, data will be sent in 1 month.
What processes are involved for a request to access data/document