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Fractional Laser in Combination With UVB Therapy in Vitiligo Patients

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ClinicalTrials.gov Identifier: NCT02290717
Recruitment Status : Withdrawn (Difficulty including patients)
First Posted : November 14, 2014
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
JELommerts, Netherlands Institute for Pigment Disorders

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.


Condition or disease Intervention/treatment Phase
Vitiligo Device: Fractional CO2 laser Other: NB-UVB therapy Drug: Fluticasone Propionate Cream 0.05% Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fractional Laser Abrasion in Combination With UVB Therapy in Vitiligo Patients: a Randomized Controlled Study.
Study Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo
Drug Information available for: Fluticasone

Arm Intervention/treatment
Experimental: Laser+fluticason+UVB
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.
Device: Fractional CO2 laser
Other: NB-UVB therapy
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.

Drug: Fluticasone Propionate Cream 0.05%
4 times a week (standard IPD protocol)

Experimental: Laser+UVB
In one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser).
Device: Fractional CO2 laser
Other: NB-UVB therapy
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.

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




Primary Outcome Measures :
  1. Repigmentation % with sheets [ Time Frame: 6 mo after treatment ]
    % of repigmentation


Secondary Outcome Measures :
  1. Global assessment physician [ Time Frame: 6 months after treatment ]
  2. Global assessment patient [ Time Frame: 6 months after treatment ]
  3. Visual assessment of hyperpigmentation/hypopigmentation/scar formation [ Time Frame: 6 months after treatment ]
  4. Global assessment of repigmentation physician [ Time Frame: 6months after treatment ]

Other Outcome Measures:
  1. Adverse events [ Time Frame: 6 months after treatment ]
  2. Color difference between erythema and (re)pigmentation [ Time Frame: 6 months after treatment ]
    with a Derma-spectrometer the difference between erythema and (re)pigmentation will be assessed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290717


Locations
Netherlands
Academic Medical Centre
Amsterdam, Netherlands
Sponsors and Collaborators
Netherlands Institute for Pigment Disorders

Publications:

Responsible Party: JELommerts, MSc MD, Netherlands Institute for Pigment Disorders
ClinicalTrials.gov Identifier: NCT02290717     History of Changes
Other Study ID Numbers: NL45970.018.13
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016

Keywords provided by JELommerts, Netherlands Institute for Pigment Disorders:
ultraviolet therapy
non segmental
vitiligo
topical corticosteroid
laser
fractional
CO2
carbon dioxide
UVB

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents