VitiligoPhase 2NCT01923142
Efficacy of Autologous Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo
A Phase 2 study testing Outer-Root-Sheath Melanocytes Suspension in people with Vitiligo, run by Centro Studi Gised at 2 sites in Italy.
Trial summary
The purpose of this study is to evaluate the hypothesis that, in patients with stable vitiligo unresponsive to conventional treatments including traditional phototherapy and/or topical steroids, the application of a non-cultured autologous hair follicle outer-root-sheath melanocytes suspension in the area affected by… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Outer-Root-Sheath Melanocytes Suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2014to Jun 2014
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of symmetric lesions of vitiligo at the back of the hands with an extension >5cm²
- Vitiligo lasting at least one year at the backs of both hands
- Stable vitiligo, defined as vitiligo that presents no evident evolution (appearance of new lesions or increase in the extension of lesions already present) for at least 6 months
- Suspension for at least two months prior to the enrollment date of any systemic drug for vitiligo such as immunosuppressive treatment (cyclosporine, systemic steroids) or psoralen + ultraviolet A therapy, phototherapy with ultraviolet B, and of any anticoagulant drug
- Suspension of topical medications for at least 15 days prior to the enrollment date
Who cannot join
- Presence of active vitiligo or Koebner phenomenon
- Difference of more than 10% in the extension of symmetrical areas of vitiligo
- Presence of systemic infections or infections localized to the tissues intended for transplantation
- History of infections to the tissues intended for transplantation (herpes simplex, human papillomavirus infections, pityriasis versicolor, pityriasis alba)
- Presence or history of malignancy
- Chemotherapy or radiation therapy in progress
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- History of allergies or adverse reactions to local anesthetics
- Presence of transmissible diseases (human immunodeficiency virus, hepatitis B and C, human T-lymphotropic virus type I and II, syphilis, cytomegalovirus, Creutzfeldt-Jacob, tuberculosis)
- Women who are pregnant or intend to become pregnant during the study period (including breastfeeding women)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Papa Giovanni XXIII Hospital
Bergamo, 24127
Spedali Civili
Brescia, 25123
About this study
Official title: Double Blind Within-Subject Controlled Study of Autologous Hair Follicle Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo
The purpose of this study is to evaluate the hypothesis that, in patients with stable vitiligo unresponsive to conventional treatments including traditional phototherapy and/or topical steroids, the application of a non-cultured autologous hair follicle outer-root-sheath melanocytes suspension in the area affected by the disease followed by targeted ultraviolet B (UVB) phototherapy can lead to a significant skin repigmentation. To assess the effect of the proposed treatment, a within-subject controlled study involving selected symmetric lesion areas localized to the back of the hands will be conducted.
- Conditions
- Vitiligo
- Being tested
- Outer-Root-Sheath Melanocytes Suspension, Placebo
- Keywords
- Vitiligo, Outer-Root-Sheath, Melanocytes, Hair Follicles
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outer-Root-Sheath Melanocytes SuspensionBiological
The treatment consists in depositing a suspension of autologous outer-root-sheath melanocytes, derived from patient's plucked hair follicles, and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week).
PlaceboBiological
The treatment consists in depositing a solution made of saline and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week).
| Study group | Role | What they receive |
|---|---|---|
| Outer-Root-Sheath Melanocytes Suspension | Experimental | This arm includes all patients sides (left or right) treated with autologous outer-root-sheath melanocytes suspension followed by targeted UVB phototherapy Receives: Biological: Outer-Root-Sheath Melanocytes Suspension |
| Placebo | Placebo comparator | This arm includes all patients sides (left or right) treated with placebo followed by targeted UVB phototherapy Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis
Measured: 12 weeks
Secondary outcomes (5)
Any repigmentation of the treated areas from baseline as assessed by physician according to an ordinal 6-points scale
Measured: 6 weeks, 12 weeks
Any repigmentation of the treated areas from baseline as assessed by patient according to an ordinal 6-points scale
Measured: 6 weeks, 12 weeks
Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale
Measured: 6 weeks, 12 weeks
Any repigmentation of the treated areas from baseline as assessed by image analysis
Measured: 6 weeks, 12 weeks
Any repigmentation of other areas affected by vitiligo from baseline as assessed by physician according to an ordinal 6-points scale (evaluation of a possible systemic effect)
Measured: 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Studi Gised
- Sponsor type
- University, hospital or other
- Collaborators
- ARIV Onlus
- Responsible party
- Sponsor
- Investigators
- Luigi Naldi, MD, Principal investigator, Centro Studi Gised
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923142
- Sponsor's protocol ID
- VIT-FOL1
- Status last verified
- Jan 2016
- First submitted
- 9 Aug 2013
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Within-Subject Controlled Study of Autologous Hair Follicle Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT01923142
- Acronym / sponsor ID
- VIT-FOL1
- Conditions
- Vitiligo
- Keywords
- Vitiligo, Outer-Root-Sheath, Melanocytes, Hair Follicles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centro Studi GisedUniversity, hospital or other
- Collaborators
- ARIV Onlus
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Aug 2013 (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 purpose of this study is to evaluate the hypothesis that, in patients with stable vitiligo unresponsive to conventional treatments including traditional phototherapy and/or topical steroids, the application of a non-cultured autologous hair follicle outer-root-sheath melanocytes suspension in the area affected by the disease followed by targeted ultraviolet B (UVB) phototherapy can lead to a significant skin repigmentation. To assess the effect of the proposed treatment, a within-subject controlled study involving selected symmetric lesion areas localized to the back of the hands will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outer-Root-Sheath Melanocytes Suspension | Experimental | Biological: Outer-Root-Sheath Melanocytes SuspensionThis arm includes all patients sides (left or right) treated with autologous outer-root-sheath melanocytes suspension followed by targeted UVB phototherapy |
| Placebo | Placebo comparator | Biological: PlaceboThis arm includes all patients sides (left or right) treated with placebo followed by targeted UVB phototherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Presence of symmetric lesions of vitiligo at the back of the hands with an extension >5cm²
- Vitiligo lasting at least one year at the backs of both hands
- Stable vitiligo, defined as vitiligo that presents no evident evolution (appearance of new lesions or increase in the extension of lesions already present) for at least 6 months
- Suspension for at least two months prior to the enrollment date of any systemic drug for vitiligo such as immunosuppressive treatment (cyclosporine, systemic steroids) or psoralen + ultraviolet A therapy, phototherapy with ultraviolet B, and of any anticoagulant drug
- Suspension of topical medications for at least 15 days prior to the enrollment date
Key exclusion criteria (9 listed)
- Presence of active vitiligo or Koebner phenomenon
- Difference of more than 10% in the extension of symmetrical areas of vitiligo
- Presence of systemic infections or infections localized to the tissues intended for transplantation
- History of infections to the tissues intended for transplantation (herpes simplex, human papillomavirus infections, pityriasis versicolor, pityriasis alba)
- Presence or history of malignancy
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 |
|---|---|---|
| Outer-Root-Sheath Melanocytes SuspensionThe treatment consists in depositing a suspension of autologous outer-root-sheath melanocytes, derived from patient's plucked hair follicles, and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week). | Biological | Outer-Root-Sheath Melanocytes Suspension |
| PlaceboThe treatment consists in depositing a solution made of saline and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week). | Biological | Placebo |
Primary outcome
Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis
Time frame: 12 weeks
5 secondary outcomes
Any repigmentation of the treated areas from baseline as assessed by physician according to an ordinal 6-points scale
Time frame: 6 weeks, 12 weeks
Any repigmentation of the treated areas from baseline as assessed by patient according to an ordinal 6-points scale
Time frame: 6 weeks, 12 weeks
Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale
Time frame: 6 weeks, 12 weeks
Any repigmentation of the treated areas from baseline as assessed by image analysis
Time frame: 6 weeks, 12 weeks
Any repigmentation of other areas affected by vitiligo from baseline as assessed by physician according to an ordinal 6-points scale (evaluation of a possible systemic effect)
Time frame: 6 weeks, 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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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.
Luigi Naldi, MD principal investigator
Centro Studi Gised
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Outer-Root-Sheath Melanocytes Suspension in people with Vitiligo, run by Centro Studi Gised at 2 sites in Italy.
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: stopped early, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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 equal to or greater than 50% of the treated areas from baseline as assessed by image analysis (time frame: 12 weeks). 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 27 Jan 2016.