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IRCT2016111630918N1 IRCT 2017-02-06 Skin and Stem Cell Research Center of Tehran University of Medical Sciences Comparing the effects of Laser and Microneedling combined with phototherapy and topical steroid for treating vitiligo in resistant localizations of body 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 2017-02-11 anticipated 80 Complete https://irct.ir/trial/24429 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Vitiligo. Intervention 1: 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. Intervention 2: 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.
public Dr Parvin Mansouri
Skin and Stem Cell research Center of Tehran University of Medical Sciences- No 4- Maryam Alley- Kamranieh Ave- Sadr Highway- Tehran- Iran
Tehran Iran (Islamic Republic of) +98 212122201710 mansorip@sina.tums.ac.ir, mansouripr@yahoo.com Skin and Stem Cell research Center of Tehran University of Medical Sciences scientific Dr Parvin Mansouri
Skin and Stem Cell research Center of Tehran University of Medical Sciences- No 4- Maryam Alley- Kamranieh Ave- Sadr Highway- Tehran- Iran
Tehran Iran (Islamic Republic of) +98 21 2220 1710 mansorip@sina.tums.ac.ir, mansouripr@yahoo.com Skin and Stem Cell research Center of Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 80 years Both L80 vITILIGO Treatment - Devices Treatment - Devices 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. 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. 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. 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. 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. Patient satisfaction. Timepoint: 6 months after intervention. Method of measurement: The patient satisfaction score based on Global Satisfaction Using Likert Score. Skin and Stem Cell Research Center of Tehran University of Medical Sciences Approved 2016-06-19 Ethic Committee of research- Tehran University of Medical Sciences 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 Tehran Iran (Islamic Republic of)