Comparing and assessment the effects of Fractional CO2 laserr and Microneedling combined with narrowband ultraviolet B and topical steroid for treating non-segmental vitiligo in resistant localizations
This study aims to compare the effectiveness of Fractional CO2 Laser and Microneedling, each in combination with Narrowband Ultraviolet B Phototherapy and topical steroid for treatment of generalized vitiligo in resistant localizations. Inclusion criteria are generalized vitiligo patients treated with Narrowband Ultraviolet B Phototherapy for 3 to 6 months but have not improved and those who have the vitiligo patches in bony prominences or end extremities which are resistant to treatment. Exclusion criteria are skin type 1, history of photosensitivity and other conditions that may have risk for patients’ interventions. The study population is 80 patients divided into two groups of 40, for random allocation of two types of interventions. For each group, combinations of therapies will be allocated. For the first group the interventional components of combinations are Narrowband Ultraviolet B, fractional CO2 laser and topical steroids. For the second group the interventional components of combinations include Narrowband Ultraviolet B, Microneedling and topical steroids. Interventional combinations in 4 modes will be allocated randomly to the four resistant vitiligo Patches. The considered time for intervention is 4 months. Patients’ follow-up begins from the beginning of interventions and lasts 6 months. The total duration of the study considering patients’ recruitment is estimated 30 months. 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:IRCT2016111630918N1
Registration date:2017-02-06, 1395/11/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-06, 1395/11/18
Registrant information
Name
Mohammadreza Rahbar
Name of organization / entity
No 4, Skin and Stem Cell Research Center- Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 212122201710
Email address
mrzrahbar@gmail.com
Recruitment status
Recruitment complete
Funding source
The funds from Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2017-02-11, 1395/11/23
Expected recruitment end date
2017-04-18, 1396/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing and assessment the effects of Fractional CO2 laserr and Microneedling combined with narrowband ultraviolet B and topical steroid for treating non-segmental vitiligo in resistant localizations
Public title
Comparing the effects of Laser and Microneedling combined with phototherapy and topical steroid for treating vitiligo in resistant localizations of body
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: non-segmental vitiligo patients (generalized vitiligo) referred to the skin and stem cell research center of Tehran University of Medical Sciences; Resistant to NUVB (had no or complete response to NBUVB after a period of 3 to 6 months) or the patches on bony prominences or end extremities which are usually resistant to NBUVB; Age more than 18 and less than 80 years old; Have patches on the extremities or trunk at least at 4 points greater than 4 cm2; The patient is willing and able to give informed written consent, Exclusion criteria: Skin type 1; History of photosensitivity; HSV recurrent skin infections; Hypertrophic scars in the patches; Colloid; Heart failure; Patients who are pregnant or lactating; Patients who are not able to understand the process that will take place for them; Patients with melanoma or non-melanoma skin cancer; Patient who has atypical and dysplastic nevus
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of research- Tehran University of Medical Sciences
Street address
The Secretary for Ethic Committee- Research and Technology Issue Management- Floor 6th- Tehran University of Medical Sciences Headquarter- Cross Ghods Ave and Bolvar Keshavarz- Tehran- Iran
City
Tehran
Postal code
Approval date
2016-06-19, 1395/03/30
Ethics committee reference number
IR.TUMS.VCR.REC.1395.152
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
1 week, 4 week, 2 months, 4 months and 6 months after start of treatment
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.
2
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.
3
Description
Reducing the size of vitiligo lesions (lesion area)
Timepoint
1 week, 4 week, 2 months, 4 months and 6 months after start of treatment
Method of measurement
The scale of decreasing the area of vitiligo patches based on Vitiligo Area Scoring Index( VASTI) which will be assessed by physician.
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
6 months after intervention
Method of measurement
The patient satisfaction score based on Global Satisfaction Using Likert Score
Intervention groups
1
Description
The second combination of interventions for the second group: 1. NB-UVB with microneedling and topical steroids for one of the vitiligo patches 2. NB-UVB therapy with Microneedling for one of the vitiligo patches 3. NB-UVB therapy with topical steroids for one of the vitiligo patches 4. NB-UVB therapy alone for one of the vitiligo patches
For the second interventional group 4 types of single or combined interventions will be allocated randomly on four vitiligo patches. Microneedling will be done 8 times, with the intervals of 2 weeks during a period of 4 months using MT.DERM GmbH, Gustav-Krone-Str.3 made by Germany. The depth of penetration for this procedure will be set on 1 mm the same as laser therapy for the first group. NB-UVB (phototherapy) UV 7001K will be done after 5 days after the first microneedling. The starting dose is 50 mj in square centimeters. It will be done twice a week for 8 weeks. Raising the therapeutic dose of phototherapy is 15 percent in each time. After starting the second half of intervention (start of 8th week) phototherapy will be done again in the same afore-mentioned protocol. Topical ointment Clobetasol .05% will be applied three times daily for 3 weeks and one week interruption. It begins again after 4th week and will be continued to 4 months after initiation of interventions. Based on above, the interventions will be accomplished for a period of 4 months. One week, 4 weeks, 2 months, 4 months and six months monitoring of different outcomes will be done after the start of interventions.
Category
Treatment - Devices
2
Description
The first combination of interventions for the first group:
1. NB-UVB therapy with CO2 Fractional Laser and topical steroids for one of the vitiligo patches
2. NB-UVB therapy with CO2 Fractional Laser for one of the vitiligo patches
3. NB-UVB therapy with topical steroids for one of the vitiligo patches
4. NB-UVB therapy alone for one of the vitiligo patches
For the first interventional group 4 types of single or combined interventions will be allocated randomly on four vitiligo patches. Two sessions of fractional CO2 laser therapy will be accomplished at the beginning and after 8 weeks using 10 600 nm eCO2 laser (Lutronic Corporation, Goyang, Korea). The energy pulse will be set on 100 Joules with 150 points per cm2 density in static state. NB-UVB (phototherapy) UV 7001K will be done after 5 days after each laser treatment. The starting dose is 50 mj in square centimeters. It will be done twice a week for 8 weeks. Raising the therapeutic dose of phototherapy is 15 percent per in each time. After the second laser treatment, phototherapy will be done again in the same afore-mentioned protocol. Topical ointment Clobetasol .05% will be applied three times daily for 3 weeks and one week interruption. It begins again after 4th week and will be continued to 4 months after initiation of interventions.
Based on above the interventions will be accomplished for a period of 4 months.
One week, 4 weeks, 2 months, 4 months and six months monitoring of different outcomes will be done after the start of interventions.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic in Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rahbar- PhD by research student
Street address
No 4- Maryam Alley- Kamranieh Ave- Sadr Highway- Tehran- Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Fattah- Executive Manager for the Skin and Stem Cell Research Center
Street address
No 4- Maryam Alley- Kamranieh Ave- Sadr Highway- Tehran- Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin and Stem Cell Research Center of Tehran 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
Skin and Stem Cell research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr Parvin Mansouri
Position
Dermatology specialist- Professor of Tehran University of Medical Sciences- Deputy for Research in S
Other areas of specialty/work
Street address
Skin and Stem Cell research Center of Tehran University of Medical Sciences- No 4- Maryam Alley- Kamranieh Ave- Sadr Highway- Tehran- Iran
City
Tehran
Postal code
Phone
+98 212122201710
Fax
Email
mansorip@sina.tums.ac.ir, mansouripr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem Cell research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr Parvin Mansouri
Position
Dermatology specialist- Superviser Professor of research- Professor of Tehran University of Medical
Other areas of specialty/work
Street address
Skin and Stem Cell research Center of Tehran University of Medical Sciences- No 4- Maryam Alley- Kamranieh Ave- Sadr Highway- Tehran- Iran
City
Tehran
Postal code
Phone
+98 21 2220 1710
Fax
Email
mansorip@sina.tums.ac.ir, mansouripr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem Cell research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rahbar
Position
Physician- PhD by Research Student
Other areas of specialty/work
Street address
Skin and Stem Cell research Center of Tehran University of Medical Sciences- No 4- Maryam Alley- Kamranieh Ave- Sadr Highway- Tehran- Iran
City
Tehran
Postal code
Phone
+98 21 2220 1710
Fax
Email
mrzrahbar@gmail.com, mrzrahbar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)