This study aims to assay the effectiveness of Fractional CO2 Laser and Microneedling, each in combination with Narrowband Ultraviolet B Phototherapy for treatment of generalized vitiligo in resistant localizations Inclusion criteria included:All patients were dermatologically diagnosed with refractory, palmar-plantar vitiligo and exclusion criteria included:hypersensitivity to laser and hair transplantation materials. The study population is 20 patients(Interventional group) and without control group. components of combinations are Narrowband Ultraviolet B, fractional CO2 laser or Microneedling. Primary expected outcomes of the study are repigmentation and reducing the size of patches and probably the occurrence of complications such as redness and irritation as the results of interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017032530808N3
Registration date:2017-04-24, 1396/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-24, 1396/02/04
Registrant information
Name
Yousef Hosseini
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 816 6606
Email address
y.hosseini@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahrom university of medical sciences
Expected recruitment start date
2016-01-13, 1394/10/23
Expected recruitment end date
2016-12-23, 1395/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assay of the CO2 fractional laser and micro needling plus hair follicle transplantation in the treatment of refractory and stable vitiligo.
Public title
The effects of Laser and Microneedling combined with phototherapy for treating vitiligo in resistant of hair skin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included:All patients were dermatologically diagnosed with refractory, palmar-plantar vitiligo
exclusion criteria included:hypersensitivity to laser and hair transplantation materials
Age
From 12 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of jahrom University of Medical Sciences
Street address
Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran
City
Jahrom
Postal code
Approval date
2015-07-09, 1394/04/18
Ethics committee reference number
IR.JUMS.REC.1394.184
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Scale of pigmentation improvement of lesion( scale of repigmentation)
Timepoint
in Three month ,each month once after intervention
Method of measurement
The scale of repigmentation (increase the amount of pigment in vitiligo patches) will be classified based on percentage of improvement in 4 grades. The ratings are: Scale 0: no repigmentation- Scale 1: Returning pigmentation between 0% to 25% which is mild pigmentation- Scale 2: The return of pigmentation 25% and 50% which is average- Scale 3: Good pigmentation which is between 50% to 75%- Scale 4: the return of pigmentation between 75% and 100% which is considered excellent. Measurements are performed by a physician through examination under a Wood's lamp and photography.
Secondary outcomes
1
Description
Complications due to interventions
Timepoint
1 week, 4 week, 2 months, 4 months and 6 months after start of treatment
Method of measurement
Every kind of local or generalized complication due to intervention which according to the confirm of dermatologist should be recorded in the questionnaire. These complications are usually redness and irritation at the site of intervention.
Intervention groups
1
Description
Comparable vitiliginous lesions were selected from both sides of the body. On Day 0, heavily pigmented follicular grafts were harvested from the scalp by follicular unit extraction and transplanted in a 1-cm grid pattern throughout the selected lesions. At Day 30±4 and Day 60±4, left-sided lesions received single treatments with fractional CO2 laser, MX-7000 (10,600 nm, 100 MJ pulse energy and 200 spots/cm3 in static mode) (Daeshin Enterprise Corporation, Seoul, Korea). Right-sided lesions received 1.5-2 mm needle length-assisted microneedling until pinpoint bleeding was achieved. On Day 30±4 and Day 60±4, silver sulfadiazine ointment was applied to treated skin, twice daily, for 5 days without occlusion.On Day 41±2, right and left-sided lesional skin received NBUVB phototherapy (dermalight 1,000/1,000 L, 800 W, Power supply: 230 V/50 Hz; Dr. Honle medizinitechnik, GmbH, Germany) three times a week until Day 60±4; phototherapy was restarted on day 71±2. The phototherapeutic dose was increased by 15% at each treatment interval and was completed by Day 100±4 (for a total of 12 weeks of treatment). Clobetasol 45% solution was applied twice daily throughout the phototherapy phase of the study.The diameter of repigmentation around each graft was measured with appropriately calibrated calipers at baseline, Day 30±4, Day 60±4 and Day 100±4.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic in Skin of Dr Feili
Full name of responsible person
Street address
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Jahrom University of Medical Sciences
Full name of responsible person
Kavoos Solhjo
Street address
Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Jahrom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
clerk
Other areas of specialty/work
Street address
Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom
City
jahrom
Postal code
Phone
+98 7157414846199
Fax
Email
navidkalani@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom university of mwdical sciences
Full name of responsible person
Amir Feily
Position
dermatology clinic of Dr feily
Other areas of specialty/work
Street address
Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom
City
jahrom
Postal code
Phone
+98 71 5423 4665
Fax
Email
dr.feily@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Navid Kalani
Position
clerk
Other areas of specialty/work
Street address
Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran Jahrom
City
Jahrom
Postal code
Phone
+98 7157414846199
Fax
Email
navidkalani@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)