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Fractional Laser in Combination With UVB Therapy in Vitiligo Patients

Primary Purpose

Vitiligo

Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Fractional CO2 laser
NB-UVB therapy
Fluticasone Propionate Cream 0.05%
Sponsored by
Netherlands Institute for Pigment Disorders
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring ultraviolet therapy, non segmental, vitiligo, topical corticosteroid, laser, fractional, CO2, carbon dioxide, UVB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Patients with non segmental (generalised) vitiligo visiting the Netherlands Institute for Pigment Disorders
  • receiving NB- UVB treatment for 3 to 6 months
  • Age >18 years
  • At least 3 therapy resistant vitiligo lesions on the extremities or trunk larger than 5x5 cm or one vitiligo lesion on the extremities or trunk of at least 5x15 cm.
  • Patient is willing and able to give written informed consent

Exclusion criteria

  • Skin type I
  • Recurrent HSV skin infections
  • Hypertrophic scars
  • Keloid
  • Cardial insufficiency
  • Patients who are pregnant or breast-feeding
  • Patients not competent to understand what the procedures involved
  • Patients with a personal history of melanoma or non-melanoma skin cancer
  • Patients with atypical nevi.

Sites / Locations

  • Academic Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Laser+fluticason+UVB

Laser+UVB

UVB

Arm Description

The treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). 5 days after laser therapy topical steroids (fluticasone cream) 4 times a week will be applied on the treatment site until the end of the study.

In one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser).

As control site, 1 similar depigmented lesion will be used. This site will receive the same NB-UVB treatment as sites 1 and 2.

Outcomes

Primary Outcome Measures

Repigmentation % with sheets
% of repigmentation

Secondary Outcome Measures

Global assessment physician
Global assessment patient
Visual assessment of hyperpigmentation/hypopigmentation/scar formation
Global assessment of repigmentation physician

Full Information

First Posted
November 7, 2014
Last Updated
April 15, 2016
Sponsor
Netherlands Institute for Pigment Disorders
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1. Study Identification

Unique Protocol Identification Number
NCT02290717
Brief Title
Fractional Laser in Combination With UVB Therapy in Vitiligo Patients
Official Title
Fractional Laser Abrasion in Combination With UVB Therapy in Vitiligo Patients: a Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty including patients
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Netherlands Institute for Pigment Disorders

4. Oversight

5. Study Description

Brief Summary
Rationale: Vitiligo is a common skin disorder that can impair a patient's quality of life. Many depigmented lesions in vitiligo patients remain therapy resistant for medical treatment. Therefore new therapeutic options in these patients are necessary. Currently, dermabrasion by conventional or fractional laser therapy in combination with NB-UVB therapy and steroids appears to be effective in therapy resistant areas. However, little literature on this combination is available. Objectives: To assess the efficacy and patient safety of (1)fractional CO2-laser treatment in combination with NB- UVB,(2) fractional CO2-laser treatment in combination with NB- UVB and topical corticosteroids versus NB-UVB treatment alone(3) Study design: Prospective observer blinded randomised intra-patient controlled study. Study population: 23 patients ≥ 18 years with non segmental vitiligo who receive NB-UVB treatment at the Netherlands Institute for Pigment Disorders (SNIP) at the Academic Medical Centre University of Amsterdam. We will include patients with 3 depigmented lesions that are resistant to NB- UVB treatment after 3 to 6 months. Methods: Three NB-UVB resistant depigmented regions on the trunk or extremities will be randomly allocated to;(1) NB-UVB treatment in combination with fractional CO2 laser abrasion, or (2) NB-UVB treatment in combination with fractional CO2 laser abrasion and topical steroids, or (3) NB-UVB treatment alone. NB-UVB treatment and topical steroids will be given according to the standard treatment protocol of the SNIP and continued for at least 6 months. Two and 6 months after the laser treatment, the percentage of repigmentation of the lesions will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
ultraviolet therapy, non segmental, vitiligo, topical corticosteroid, laser, fractional, CO2, carbon dioxide, UVB

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser+fluticason+UVB
Arm Type
Experimental
Arm Description
The treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). 5 days after laser therapy topical steroids (fluticasone cream) 4 times a week will be applied on the treatment site until the end of the study.
Arm Title
Laser+UVB
Arm Type
Experimental
Arm Description
In one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser).
Arm Title
UVB
Arm Type
Active Comparator
Arm Description
As control site, 1 similar depigmented lesion will be used. This site will receive the same NB-UVB treatment as sites 1 and 2.
Intervention Type
Device
Intervention Name(s)
Fractional CO2 laser
Intervention Type
Other
Intervention Name(s)
NB-UVB therapy
Intervention Description
NB-UVB therapy (according to the standard treatment protocol of the SNIP, which the patient is already been treated with) will be continued for both treated and control sites during 6 months.
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate Cream 0.05%
Intervention Description
4 times a week (standard IPD protocol)
Primary Outcome Measure Information:
Title
Repigmentation % with sheets
Description
% of repigmentation
Time Frame
6 mo after treatment
Secondary Outcome Measure Information:
Title
Global assessment physician
Time Frame
6 months after treatment
Title
Global assessment patient
Time Frame
6 months after treatment
Title
Visual assessment of hyperpigmentation/hypopigmentation/scar formation
Time Frame
6 months after treatment
Title
Global assessment of repigmentation physician
Time Frame
6months after treatment
Other Pre-specified Outcome Measures:
Title
Adverse events
Time Frame
6 months after treatment
Title
Color difference between erythema and (re)pigmentation
Description
with a Derma-spectrometer the difference between erythema and (re)pigmentation will be assessed.
Time Frame
6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patients with non segmental (generalised) vitiligo visiting the Netherlands Institute for Pigment Disorders receiving NB- UVB treatment for 3 to 6 months Age >18 years At least 3 therapy resistant vitiligo lesions on the extremities or trunk larger than 5x5 cm or one vitiligo lesion on the extremities or trunk of at least 5x15 cm. Patient is willing and able to give written informed consent Exclusion criteria Skin type I Recurrent HSV skin infections Hypertrophic scars Keloid Cardial insufficiency Patients who are pregnant or breast-feeding Patients not competent to understand what the procedures involved Patients with a personal history of melanoma or non-melanoma skin cancer Patients with atypical nevi.
Facility Information:
Facility Name
Academic Medical Centre
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21834930
Citation
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Results Reference
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PubMed Identifier
22050270
Citation
Shin J, Lee JS, Hann SK, Oh SH. Combination treatment by 10 600 nm ablative fractional carbon dioxide laser and narrowband ultraviolet B in refractory nonsegmental vitiligo: a prospective, randomized half-body comparative study. Br J Dermatol. 2012 Mar;166(3):658-61. doi: 10.1111/j.1365-2133.2011.10723.x. Epub 2012 Jan 19.
Results Reference
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PubMed Identifier
21824124
Citation
Bayoumi W, Fontas E, Sillard L, Le Duff F, Ortonne JP, Bahadoran P, Lacour JP, Passeron T. Effect of a preceding laser dermabrasion on the outcome of combined therapy with narrowband ultraviolet B and potent topical steroids for treating nonsegmental vitiligo in resistant localizations. Br J Dermatol. 2012 Jan;166(1):208-11. doi: 10.1111/j.1365-2133.2011.10564.x. Epub 2011 Nov 17.
Results Reference
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PubMed Identifier
19577331
Citation
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Results Reference
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PubMed Identifier
15948977
Citation
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Results Reference
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PubMed Identifier
21839315
Citation
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Results Reference
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Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Fractional Laser in Combination With UVB Therapy in Vitiligo Patients

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