Comparison of the additive effect of topical psoralen with ultraviolet A (PUVA) phototherapy after suction blister epidermal grafting surgery in patients with acral vitiligo
Determination of the additive effect of topical psoralen with ultraviolet A (PUVA) phototherapy after suction blister epidermal grafting surgery in patients with acral vitiligo
Design
Phase 3, parallel group, clinical trial, with consecutive sampling, including 20 patients, single blinded, computerized randomized with permuted blocks
Settings and conduct
The study is conducted in the Imam Reza laser clinic of Shiraz University of Medical Sciences with suction blister epidermal grafting surgery for treatment of vitiligo on the dorsa of hands or feet in both groups. In each patient only one side undergoes topical psoralen with ultraviolet A (PUVA) phototherapy randomely (Twice weekly for 6 months), besides the graft, and the other side is not treated with phototherapy. The patients are assessed at the beginning of treatment, months 1,2,4, and 6 by photography. The investigator is blind to the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Acral vitiligo; 18 years of age and higher; Bilateral lesions; Stable vitiligo in the past 6 months; Ability to refer for phototherapy; Minimum size of 1*1 cm; Maximum size of 3*3 cm
Exclusion criteria: History of keloid; Treatment for vitiligo in the past one month; Poor wound healing; Consumption of anticoagulant drugs; Consumption of immunosuppresant drugs; Pregnancy; Lactation
Intervention groups
Suction blister epidermal grafting surgery with topical psoralen with ultraviolet A (PUVA) phototherapy in one side hand or foot (Twice weekly for 6 months)
Main outcome variables
Reversal of normal skin pigment, measured by Reverse Vitiligo Area Severity Index (VASI), and Vitiligo Extent Score for a Target Area (VESTA)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140212016557N9
Registration date:2021-10-07, 1400/07/15
Registration timing:registered_while_recruiting
Last update:2021-10-07, 1400/07/15
Update count:0
Registration date
2021-10-07, 1400/07/15
Registrant information
Name
Mozhdeh Sepaskhah
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 712125239
Email address
sepaskhah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the additive effect of topical psoralen with ultraviolet A (PUVA) phototherapy after suction blister epidermal grafting surgery in patients with acral vitiligo
Public title
Effect of skin graft with and without phototherapy in the treatment of acral vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acral vitiligo
18 years of age and higher
Bilateral lesions
Stable vitiligo in the past 6 months
Ability to refer for phototherapy
Minimum size of 1*1 cm
Maximum size of 3*3 cm
Exclusion criteria:
History of keloid
Treatment for vitiligo in the past one month
Poor wound healing
Consumption of anticoagulant drugs
Consumption of immunosuppresant drugs
Pregnancy
Lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomized using permuted block randomization (size of each block: 4), in individual units, using random allocation software. The output of software is a table that determines the right or left side undergoes phototherapy.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the different treatment methods in two sides, the participants cannot be blinded. Principle investigator, and care provider physician are also aware of the the side undergoing phototherapy. But, outcome assessors are not aware of the side undergoing phototherapy in each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz. Iran
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2021-08-19, 1400/05/28
Ethics committee reference number
IR.SUMS.MED.REC.1400.265
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Reversal of normal skin pigment
Timepoint
Months 1, 2, 4, and 6
Method of measurement
Reverse Vitiligo Area Severity Index (VASI), which measures the percentage of pigment reversal.
2
Description
Vitiligo Extent Score for a Target Area (VESTA)
Timepoint
Months 1, 2, 4, and 6
Method of measurement
A formula that considers fully repigmented area, remaining area, and perifollicular repigmentation in the remaining area.
Secondary outcomes
1
Description
Time of pigment reversal
Timepoint
Months 1, 2, 4, and 6
Method of measurement
Measurement of the numbers of weeks to achieve 50% pigment reversal
2
Description
Color match
Timepoint
Months 1, 2, 4, and 6
Method of measurement
Difference of the lesion color with surrounding normal skin color measured by colorimetric device
3
Description
Quality of Life
Timepoint
At the beginning and end of treatment
Method of measurement
Vitiligo Quality of Life index (VitiQoL)
4
Description
Patient satisfaction
Timepoint
At the end of treatment
Method of measurement
Three questions with answers from 0 to 10
Intervention groups
1
Description
Intervention group: Suction blister epidermal grafting surgery with topical psoralen with ultraviolet A (PUVA) phototherapy in one side hand or foot (Twice weekly for 6 months)
Category
Treatment - Surgery
2
Description
Control group: Suction blister epidermal grafting surgery without topical psoralen with ultraviolet A (PUVA) phototherapy in one side hand or foot
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Laser clinic, Imam Reza clinic
Full name of responsible person
Mozhdeh Sepaskhah
Street address
Laser clinic, Imam Reza clinic, Namazi Sq.
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7001
Email
sepaskhah@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaianzade
Street address
Research Council, Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Research grant of the Research Council of Shiraz University of Medical Sciences
Grant code / Reference number
23448
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Amirhossein Heydarnejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 712125239
Fax
+98 71 3231 9049
Email
amirhosseinheydarnejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 712125239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate Prifessor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 712125239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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