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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016111630918N1
Enrollment
80
Registered
2017-02-06
Start date
2017-02-11
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo. vITILIGO

Interventions

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
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 viti
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 La

Sponsors

Skin and Stem Cell Research Center of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Patient satisfaction. Timepoint: 6 months after intervention. Method of measurement: The patient satisfaction score based on Global Satisfaction Using Likert Score.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Parvin Mansouri

Skin and Stem Cell research Center of Tehran University of Medical Sciences

mansorip@sina.tums.ac.ir, mansouripr@yahoo.com+98 212122201710

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026