VitiligoNCT00615355
Epidermal Cell Transplantation in Vitiligo Skin With and Without Narrow-band Ultraviolet B (UVB) Treatment
A study testing UVB 311 nm radiation and UVB 311nm in people with Vitiligo, run by Medical University of Graz at 1 site in Austria.
Trial summary
The effect of treatment with narrow-band UVB 311 nm after transplantation of harvested autologous epidermal cells on vitiligo lesions will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- UVB 311 nm radiation and UVB 311nm
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2008to Dec 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 11 female or male vitiligo patients between the age of 18 and 70
- Stable vitiligo for at least 1 year
Who cannot join
- Progressive disease within the last 12 months
- Sporadic repigmentation of single patches within the last 12 months
- Patients with contraindications for UV-treatment
- Patients with anticoagulant treatment, bleeding disorders
- Patients with prolonged wound healing in the history
- History of hypertrophic scarring or keloids or Köbner phenomenon
Show all 11Show fewer
- Reduced general health status
- Patients with allergic reactions to local anaesthesia
- Topical steroids or calcineurin inhibitors in the last 4 weeks before study entry
- UV exposure in the last 4 weeks before study entry
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Narrow-band UVB Treatment After Transplantation of Harvested Epidermal Cells in Vitiligo
The effect of treatment with narrow-band UVB 311 nm after transplantation of harvested autologous epidermal cells on vitiligo lesions will be investigated.
Read the detailed description
Introduction: Surgical interventions in vitiligo are widely used and additional UV exposure is often recommended after successful transplantation. However, little is known about the additional efficacy of (narrow-band) UVB due to missing comparative studies.
Aim of the study: To perform a prospective, controlled, randomized, intra-individual comparative study in vitiligo lesions treated with epidermal cell transplantation using the ReCell method with and without additional narrow-band UVB treatment.
Study design: Two weeks after transplantation of epidermal cells, one randomly chosen half of the transplanted patch will be additionally treated with narrow-band UVB therapy whereas the other half will be left untreated. For control purpose, 2 additional patches (or the two halfs of one patch) will be selected to be treated with either laser dermabrasion and narrow-band UVB or narrow-band UVB treatment alone.
Grafting with the ReCell method: A superficial skin shaving excision of 2 x 2 cm will be obtained from pigmented skin (UVA irradiation 4 weeks before the excision) using a Silver knife. A cell suspension will be obtained using the ReCell transplantation kit, according to the instructions of the manufactures. The vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. Thereafter the cell suspension will be sprayed on the dermabraded skin area and fixed with special wound dressings.
Narrow-band UVB treatment: The initial UVB dose will be 50% of the minimal erythema dose, tested next to the vitiligo lesions to be treated. Treatment will be performed 2 times a week with a targeted UVB device (Dualight, TheraLight). Dose increments will be 30 mJ/cm2 at each treatment up to a dose that induces slight erythema longer than 24 hours. If this dose is reached, the dose will be reduced to the last well tolerated dose and no further increments will follow. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.
Evaluation of the treatment success: The grade of pigmentation in all lesions will be evaluated clinically, with photographs and with laser scanning microscope every 3 weeks during the first 3 months of the study and later every 3 months within the first year. The clinical rating will be performed as follows: 0 = no repigmentation; 1 = 1-25% repigmentation; 2 = 26 to 50% repigmentation; 3 = 51 to 75% repigmentation; and 4 = 76 to 100% repigmentation. The evaluation of the photographs and the laser scanning microscopy pictures will be performed blinded by physicians not engaged in the treatment phase of the study.
- Conditions
- Vitiligo
- Being tested
- UVB 311 nm radiation, UVB 311nm
- Keywords
- vitiligo, narrow-band UVB, ReCell, transplantation, laser
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVB 311 nm radiationRadiation
Also called narrow-band UVB
UVB 311 nm radiation randomized to one half of the transplanted vitiligo lesion given 2 times a week for 3 months; the other half of the transplanted lesion remains UV-non-irradiated
UVB 311nmDevice
Repeated UVB 311nm narrowband irradiation (24 exposures)
| Study group | Role | What they receive |
|---|---|---|
| Body location | Other | Different body locations receive specific treatments Receives: Radiation: UVB 311 nm radiation |
| Control | Active comparator | Treatment with narrow-band UVB Receives: Radiation: UVB 311 nm radiation; Device: UVB 311nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of repigmentation
Measured: 3 and 6 months after transplantation
Secondary outcomes (1)
stability of the achieved repigmentation
Measured: one year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelika Hofer, Principal investigator, Medical Univsersity of Graz, Department of Dermatology, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615355
- Sponsor's protocol ID
- 18-262 ex 06/07
- Status last verified
- Jan 2017
- First submitted
- 2 Feb 2008
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Narrow-band UVB Treatment After Transplantation of Harvested Epidermal Cells in Vitiligo
- ClinicalTrials.gov ID
- NCT00615355
- Acronym / sponsor ID
- 18-262 ex 06/07
- Conditions
- Vitiligo
- Keywords
- vitiligo, narrow-band UVB, ReCell, transplantation, laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Feb 2008 (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.
The effect of treatment with narrow-band UVB 311 nm after transplantation of harvested autologous epidermal cells on vitiligo lesions will be investigated.
Detailed description
Introduction: Surgical interventions in vitiligo are widely used and additional UV exposure is often recommended after successful transplantation. However, little is known about the additional efficacy of (narrow-band) UVB due to missing comparative studies.
Aim of the study: To perform a prospective, controlled, randomized, intra-individual comparative study in vitiligo lesions treated with epidermal cell transplantation using the ReCell method with and without additional narrow-band UVB treatment.
Study design: Two weeks after transplantation of epidermal cells, one randomly chosen half of the transplanted patch will be additionally treated with narrow-band UVB therapy whereas the other half will be left untreated. For control purpose, 2 additional patches (or the two halfs of one patch) will be selected to be treated with either laser dermabrasion and narrow-band UVB or narrow-band UVB treatment alone.
Grafting with the ReCell method: A superficial skin shaving excision of 2 x 2 cm will be obtained from pigmented skin (UVA irradiation 4 weeks before the excision) using a Silver knife. A cell suspension will be obtained using the ReCell transplantation kit, according to the instructions of the manufactures. The vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. Thereafter the cell suspension will be sprayed on the dermabraded skin area and fixed with special wound dressings.
Narrow-band UVB treatment: The initial UVB dose will be 50% of the minimal erythema dose, tested next to the vitiligo lesions to be treated. Treatment will be performed 2 times a week with a targeted UVB device (Dualight, TheraLight). Dose increments will be 30 mJ/cm2 at each treatment up to a dose that induces slight erythema longer than 24 hours. If this dose is reached, the dose will be reduced to the last well tolerated dose and no further increments will follow. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.
Evaluation of the treatment success: The grade of pigmentation in all lesions will be evaluated clinically, with photographs and with laser scanning microscope every 3 weeks during the first 3 months of the study and later every 3 months within the first year. The clinical rating will be performed as follows: 0 = no repigmentation; 1 = 1-25% repigmentation; 2 = 26 to 50% repigmentation; 3 = 51 to 75% repigmentation; and 4 = 76 to 100% repigmentation. The evaluation of the photographs and the laser scanning microscopy pictures will be performed blinded by physicians not engaged in the treatment phase of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body location | Other | Radiation: UVB 311 nm radiationDifferent body locations receive specific treatments |
| Control | Active comparator | Radiation: UVB 311 nm radiation, Device: UVB 311nmTreatment with narrow-band UVB |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 11 female or male vitiligo patients between the age of 18 and 70
- Stable vitiligo for at least 1 year
Key exclusion criteria (11 listed)
- Progressive disease within the last 12 months
- Sporadic repigmentation of single patches within the last 12 months
- Patients with contraindications for UV-treatment
- Patients with anticoagulant treatment, bleeding disorders
- Patients with prolonged wound healing in the history
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 |
|---|---|---|
| UVB 311 nm radiationAlso: narrow-band UVBUVB 311 nm radiation randomized to one half of the transplanted vitiligo lesion given 2 times a week for 3 months; the other half of the transplanted lesion remains UV-non-irradiated | Radiation | Body location, Control |
| UVB 311nmRepeated UVB 311nm narrowband irradiation (24 exposures) | Device | Control |
Primary outcome
percentage of repigmentation
Time frame: 3 and 6 months after transplantation
1 secondary outcome
stability of the achieved repigmentation
Time frame: one year after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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.
Angelika Hofer principal investigator
Medical Univsersity of Graz, Department of Dermatology, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVB 311 nm radiation and UVB 311nm in people with Vitiligo, run by Medical University of Graz at 1 site in Austria.
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 2 inclusion and 11 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: finished, as of the sponsor's last update on 12 Jan 2017. 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 Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percentage of repigmentation (time frame: 3 and 6 months after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2017.