VitiligoNCT02290717

Fractional Laser in Combination With UVB Therapy in Vitiligo Patients

A study testing Fractional CO2 laser, NB-UVB therapy and Fluticasone Propionate Cream 0.05% in people with Vitiligo, run by Netherlands Institute for Pigment Disorders at 1 site in Netherlands.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Vitiligo
What is being tested?: Fractional CO2 laser, NB-UVB therapy and Fluticasone Propionate Cream 0.05%
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteNetherlands
Study dates: May 2015to Nov 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Skin type I
Recurrent HSV skin infections
Hypertrophic scars
Keloid
Cardial insufficiency
Patients who are pregnant or breast-feeding

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Academic Medical Centre
Amsterdam

Other trials in Netherlands

About this study

Official title: Fractional Laser Abrasion in Combination With UVB Therapy in Vitiligo Patients: a Randomized Controlled Study.

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.

Conditions: Vitiligo
Being tested: Fractional CO2 laser, NB-UVB therapy, Fluticasone Propionate Cream 0.05%
Keywords: ultraviolet therapy, non segmental, vitiligo, topical corticosteroid, laser, fractional, CO2, carbon dioxide, UVB
Medical subject headings: Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fractional CO2 laserDevice
NB-UVB therapyOther
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.
Fluticasone Propionate Cream 0.05%Drug
4 times a week (standard IPD protocol)

Study groups in NCT02290717
Study group	Role	What they receive
Laser+fluticason+UVB	Experimental	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. Receives: Device: Fractional CO2 laser; Other: NB-UVB therapy; Drug: Fluticasone Propionate Cream 0.05%
Laser+UVB	Experimental	In one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser). Receives: Device: Fractional CO2 laser; Other: NB-UVB therapy
UVB	Active comparator	As control site, 1 similar depigmented lesion will be used. This site will receive the same NB-UVB treatment as sites 1 and 2. Receives: Other: NB-UVB therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Repigmentation % with sheets
% of repigmentation
Measured: 6 mo after treatment

Secondary outcomes (4)

Global assessment physician
Measured: 6 months after treatment
Global assessment patient
Measured: 6 months after treatment
Visual assessment of hyperpigmentation/hypopigmentation/scar formation
Measured: 6 months after treatment
Global assessment of repigmentation physician
Measured: 6months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Nov 2015

First posted14 Nov 2014 (estimated)
Study startMay 2015
Primary completionNov 2015
Study completionNov 2015

Why it stopped: Difficulty including patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for VitiligoStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02290717
Sponsor's protocol ID: NL45970.018.13
Status last verified: Apr 2016
First submitted: 7 Nov 2014
Last updated: 18 Apr 2016
Results posted: No

Publications

Garg T, Chander R, Jain A. Combination of microdermabrasion and 5-fluorouracil to induce repigmentation in vitiligo: an observational study. Dermatol Surg. 2011 Dec;37(12):1763-6. doi: 10.1111/j.1524-4725.2011.02127.x. Epub 2011 Aug 11.
PubMed 21834930
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.
PubMed 22050270
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.
PubMed 21824124
Linthorst Homan MW, Spuls PI, de Korte J, Bos JD, Sprangers MA, van der Veen JP. The burden of vitiligo: patient characteristics associated with quality of life. J Am Acad Dermatol. 2009 Sep;61(3):411-20. doi: 10.1016/j.jaad.2009.03.022. Epub 2009 Jul 3.
PubMed 19577331
Ongenae K, Van Geel N, De Schepper S, Naeyaert JM. Effect of vitiligo on self-reported health-related quality of life. Br J Dermatol. 2005 Jun;152(6):1165-72. doi: 10.1111/j.1365-2133.2005.06456.x.
PubMed 15948977
Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
PubMed 21839315
Drake LA, Dinehart SM, Farmer ER, Goltz RW, Graham GF, Hordinsky MK, Lewis CW, Pariser DM, Skouge JW, Turner ML, Webster SB, Whitaker DC, Lowery BJ, Nordlund JJ, Grimes PE, Halder RM, Minus HR. Guidelines of care for vitiligo. American Academy of Dermatology. J Am Acad Dermatol. 1996 Oct;35(4):620-6. doi: 10.1016/s0190-9622(96)90691-x. No abstract available.
PubMed 8859294
Njoo MD, Westerhof W. Vitiligo. Pathogenesis and treatment. Am J Clin Dermatol. 2001;2(3):167-81. doi: 10.2165/00128071-200102030-00006.
PubMed 11705094
Taieb A, Picardo M. Clinical practice. Vitiligo. N Engl J Med. 2009 Jan 8;360(2):160-9. doi: 10.1056/NEJMcp0804388. No abstract available.
PubMed 19129529
Taieb A, Alomar A, Bohm M, Dell'anna ML, De Pase A, Eleftheriadou V, Ezzedine K, Gauthier Y, Gawkrodger DJ, Jouary T, Leone G, Moretti S, Nieuweboer-Krobotova L, Olsson MJ, Parsad D, Passeron T, Tanew A, van der Veen W, van Geel N, Whitton M, Wolkerstorfer A, Picardo M; Vitiligo European Task Force (VETF); European Academy of Dermatology and Venereology (EADV); Union Europe enne des Me decins Spe cialistes (UEMS). Guidelines for the management of vitiligo: the European Dermatology Forum consensus. Br J Dermatol. 2013 Jan;168(1):5-19. doi: 10.1111/j.1365-2133.2012.11197.x. Epub 2012 Nov 2.
PubMed 22860621
Lotti T, Buggiani G, Troiano M, Assad GB, Delescluse J, De Giorgi V, Hercogova J. Targeted and combination treatments for vitiligo. Comparative evaluation of different current modalities in 458 subjects. Dermatol Ther. 2008 Jul;21 Suppl 1:S20-6. doi: 10.1111/j.1529-8019.2008.00198.x.
PubMed 18727812
Farajzadeh S, Daraei Z, Esfandiarpour I, Hosseini SH. The efficacy of pimecrolimus 1% cream combined with microdermabrasion in the treatment of nonsegmental childhood vitiligo: a randomized placebo-controlled study. Pediatr Dermatol. 2009 May-Jun;26(3):286-91. doi: 10.1111/j.1525-1470.2009.00926.x.
PubMed 19706089
van Geel N, Ongenae K, Naeyaert JM. Surgical techniques for vitiligo: a review. Dermatology. 2001;202(2):162-6. doi: 10.1159/000051626.
PubMed 11306848

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vitiligo trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fractional Laser Abrasion in Combination With UVB Therapy in Vitiligo Patients: a Randomized Controlled Study.
ClinicalTrials.gov ID: NCT02290717
Acronym / sponsor ID: NL45970.018.13
Conditions: Vitiligo
Keywords: ultraviolet therapy, non segmental, vitiligo, topical corticosteroid, laser, fractional, CO2, carbon dioxide
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Difficulty including patients
Enrolment: 0 participants (actual)
Lead sponsor: Netherlands Institute for Pigment DisordersUniversity, hospital or other
Study start: May 2015
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 14 Nov 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Laser+fluticason+UVB	Experimental	Device: Fractional CO2 laser, Other: NB-UVB therapy, Drug: Fluticasone Propionate Cream 0.05%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.
Laser+UVB	Experimental	Device: Fractional CO2 laser, Other: NB-UVB therapyIn one session the treatment site will be superficially abraded using an ablative fractional laser (10,600nm CO2 laser).
UVB	Active comparator	Other: NB-UVB therapyAs control site, 1 similar depigmented lesion will be used. This site will receive the same NB-UVB treatment as sites 1 and 2.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

Skin type I
Recurrent HSV skin infections
Hypertrophic scars
Keloid
Cardial insufficiency

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fractional CO2 laser	Device	Laser+UVB, Laser+fluticason+UVB
NB-UVB therapyNB-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.	Other	Laser+UVB, Laser+fluticason+UVB, UVB
Fluticasone Propionate Cream 0.05%4 times a week (standard IPD protocol)	Drug	Laser+fluticason+UVB

Primary outcome

Repigmentation % with sheets
Time frame: 6 mo after treatment
% of repigmentation

4 secondary outcomes

Global assessment physician
Time frame: 6 months after treatment
Global assessment patient
Time frame: 6 months after treatment
Visual assessment of hyperpigmentation/hypopigmentation/scar formation
Time frame: 6 months after treatment
Global assessment of repigmentation physician
Time frame: 6months after treatment

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
Background: PubMed 21834930Garg T, Chander R, Jain A. Combination of microdermabrasion and 5-fluorouracil to induce repigmentation in vitiligo: an observational study. Dermatol Surg. 2011 Dec;37(12):1763-6. doi: 10.1111/j.1524-4725.2011.02127.x. Epub 2011 Aug 11.
Background: PubMed 22050270Shin 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.
Background: PubMed 21824124Bayoumi 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.
Background: PubMed 19577331Linthorst Homan MW, Spuls PI, de Korte J, Bos JD, Sprangers MA, van der Veen JP. The burden of vitiligo: patient characteristics associated with quality of life. J Am Acad Dermatol. 2009 Sep;61(3):411-20. doi: 10.1016/j.jaad.2009.03.022. Epub 2009 Jul 3.
Background: PubMed 15948977Ongenae K, Van Geel N, De Schepper S, Naeyaert JM. Effect of vitiligo on self-reported health-related quality of life. Br J Dermatol. 2005 Jun;152(6):1165-72. doi: 10.1111/j.1365-2133.2005.06456.x.
Background: PubMed 21839315Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
Background: PubMed 8859294Drake LA, Dinehart SM, Farmer ER, Goltz RW, Graham GF, Hordinsky MK, Lewis CW, Pariser DM, Skouge JW, Turner ML, Webster SB, Whitaker DC, Lowery BJ, Nordlund JJ, Grimes PE, Halder RM, Minus HR. Guidelines of care for vitiligo. American Academy of Dermatology. J Am Acad Dermatol. 1996 Oct;35(4):620-6. doi: 10.1016/s0190-9622(96)90691-x. No abstract available.
Background: PubMed 11705094Njoo MD, Westerhof W. Vitiligo. Pathogenesis and treatment. Am J Clin Dermatol. 2001;2(3):167-81. doi: 10.2165/00128071-200102030-00006.
Background: PubMed 19129529Taieb A, Picardo M. Clinical practice. Vitiligo. N Engl J Med. 2009 Jan 8;360(2):160-9. doi: 10.1056/NEJMcp0804388. No abstract available.
Background: PubMed 22860621Taieb A, Alomar A, Bohm M, Dell'anna ML, De Pase A, Eleftheriadou V, Ezzedine K, Gauthier Y, Gawkrodger DJ, Jouary T, Leone G, Moretti S, Nieuweboer-Krobotova L, Olsson MJ, Parsad D, Passeron T, Tanew A, van der Veen W, van Geel N, Whitton M, Wolkerstorfer A, Picardo M; Vitiligo European Task Force (VETF); European Academy of Dermatology and Venereology (EADV); Union Europe enne des Me decins Spe cialistes (UEMS). Guidelines for the management of vitiligo: the European Dermatology Forum consensus. Br J Dermatol. 2013 Jan;168(1):5-19. doi: 10.1111/j.1365-2133.2012.11197.x. Epub 2012 Nov 2.
Background: PubMed 18727812Lotti T, Buggiani G, Troiano M, Assad GB, Delescluse J, De Giorgi V, Hercogova J. Targeted and combination treatments for vitiligo. Comparative evaluation of different current modalities in 458 subjects. Dermatol Ther. 2008 Jul;21 Suppl 1:S20-6. doi: 10.1111/j.1529-8019.2008.00198.x.
Background: PubMed 19706089Farajzadeh S, Daraei Z, Esfandiarpour I, Hosseini SH. The efficacy of pimecrolimus 1% cream combined with microdermabrasion in the treatment of nonsegmental childhood vitiligo: a randomized placebo-controlled study. Pediatr Dermatol. 2009 May-Jun;26(3):286-91. doi: 10.1111/j.1525-1470.2009.00926.x.

Related trials for Vitiligo

RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fractional CO2 laser, NB-UVB therapy and Fluticasone Propionate Cream 0.05% in people with Vitiligo, run by Netherlands Institute for Pigment Disorders at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Repigmentation % with sheets (time frame: 6 mo after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02290717, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.