Non Segmental VitiligoNCT06619184
Transplantation of Autologous Non-Cultured Extracted Hair Follicle Outer Root Sheath Cell Suspension and Mini Punch Graft for Stable Non-Segmental Vitiligo Lesions
A study testing NCEHFORSCS transplantation and MPG procedure in people with Non Segmental Vitiligo, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Vitiligo is an acquired pigmentation disorder due to loss of melanocytes characterized by depigmentation macules or patches. One type of this disease is nonsegmental vitiligo (NSV). Until now, there is no satisfactory treatment for vitiligo. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Segmental Vitiligo
- What is being tested?
- NCEHFORSCS transplantation and MPG procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2022to 30 Sep 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-Segmental Vitiligo patients
- Minimal 1-year duration of stability
- Age between 18-70 years
- Having at least two vitiligo lesions for NCEHFORSCS transplantation and MPG procedure
- The two vitiligo lesions to be treated must meet the following criteria:
- Have similar size, minimum of 1 cm² and a maximum of 20 cm²
Show all 9Show fewer
- The distance between the two lesions at least 1 cm
- Location of the lesions must have a relatively similar distribution of hair follicles
- Not located on the palms, soles, or penis
Who cannot join
- Pregnant
- Active vitiligo
- Mixed vitiligo
- Presence of new lesions
- History of hypertrophic scars and keloids
- History of bleeding disorders
- Other active autoimmune diseases
- History of wound healing disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Effectiveness Between Transplantation of Autologous Non-Cultured Extracted Hair Follicle Outer Root Sheath Cell Suspension and Mini Punch Graft in Non-Segmental Vitiligo
Vitiligo is an acquired pigmentation disorder due to loss of melanocytes characterized by depigmentation macules or patches. One type of this disease is nonsegmental vitiligo (NSV). Until now, there is no satisfactory treatment for vitiligo. Vitiligo therapies are medical therapy include topical and systemic therapy, phototherapy as well as surgery. Surgical treatment is indicated in stable vitiligo, which is not responding to medical treatment. This procedure consists of tissue grafting and cellular transplantation. Mini punch graft (MPG) is the most frequently performed tissue transplantation technique, while cellular transplantation from autologous noncultured extracted hair follicle outer root sheath cell suspension (NCEHFORSCS) containing melanocyte stem cells, is currently a promising option.
Read the detailed description
Current NSV treatments can be considered suboptimal and leading to decreased patient's quality of life due to the emotional burden of therapy dissatisfaction. When a stable NSV is not responding to medical therapy, surgery may be a useful treatment approach. All surgical techniques in vitiligo treatment share the same principle: transferring autologous melanocytes from a donor to repopulate melanocytes in the depigmented area that lacks a reservoir or fails to activate melanocytes in the outer root sheath (ORS) of hair follicles. MPG as the most frequently performed tissue transplantation technique transferred the epidermal melanocyte to vitiligo lesion, while NCEHFORSCS provides melanocytes with better properties and contains melanocyte stem cells. The advantages of melanocytes from ORS compared to epidermal are the follicular melanocyte:keratinocyte ratio consists of one melanocyte for every five keratinocytes or 1:5 in the hair bulb, melanocytes are more dendritic, have larger melanosomes, and have the potential to produce more melanin pigment. Due to these properties, hair follicles can be a better source of melanocytes than epidermis in the delivery of cellular transplantation-based therapy for vitiligo therapy. Research comparing the effectiveness of the two procedures has never been conducted in Indonesia, even though the incidence of vitiligo is quite high and the success of therapy is still not optimal. So the purpose of this study is to compare the effectiveness of the two procedures in NSV patient.
- Conditions
- Non Segmental Vitiligo
- Being tested
- NCEHFORSCS transplantation, MPG procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCEHFORSCS transplantationProcedure or surgery
One vitiligo lesion of participans treated with NCEHFORSCS transplantation including follicle unit extraction (FUE) procedure from the occipital area, laboratory procedure for preparation of cell suspension, and transplantation of NCEHFORSCS.
MPG procedureProcedure or surgery
Another vitiligo lesion treated with MPG procedure
Follow up The dressing was removed by the researcher on day 8 The participants were asked to attend for follow-up at the clinic on week 2, 4, 8, 12, and 16 after the two procedure were done.
At 2, 4, 8, 12 and 16 weeks of follow-up visits, any possible complications were evaluated and digital photographs of the lesions were taken for evaluating the two procedure efficacy using its parameter: appearance of repigmentation (AOR), total number of repigmentation NSV lesions, extent area of repigmentation, and color match
| Study group | Role | What they receive |
|---|---|---|
| NCEHFORSCS transplantation and MPG procedure | Experimental | The research was conducted on 21 participants.
Two vitiligo lesions from each participant that met the inclusion and exclusion criteria were treated with NCEHFORSCS transplantation and MPG procedure followed by observation of repigmentation.
The participants were informed that a series of procedures would be performed, including hair follicle extraction using the follicle unit extraction (FUE) procedure, followed by the preparation of NCEHFORSCS in PT Prodia StemCell Indonesia (ProSTEM®) laboratory, and transplantation of NCEHFORSCS on one VNS lesion while MPG procedure was performed on another lesion.
Follow-up was carried out at the 2nd week, 4th week, 8th week, 12th week, and 16th week after the NCEHFORSCS transplantation and MPG procedures to assess repigmentation of the lesions and side effects of the procedures. Receives: Procedure: NCEHFORSCS transplantation; Procedure: MPG procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of repigmentation (AOR)
The first appearance of repigmentation in non-segmental vitiligo (NSV) lesions after NCEHFORSCS transplantation and MPG procedure evaluated by blind investigator using dermoscope at weeks 2, -4, -8, -12, and -16
Measured: 4 months
Total number of repigmentation non-segmental vitiligo (NSV) lesions
Total number of NSV lesions that experienced repigmentation at the 16th week of observation
Measured: 4 months
Extent area of repigmentation
The repigmentation area percentage level of non-segmental vitiligo (NSV) lesions after NCEHFORSCS transplantation and MPG procedure determine by blind investigator using the digital images.
The scores were confirmed by objective measurement of the extent of repigmentation by a digital image analysis system ImageJ® as follow:
No repigmentation (0%) Poor repigmentation (0,1-49%) Fair repigmentation (50-74%) Good repigmentation (75-89%) Excellent repigmentation (90-100%)
Measured: 4 months
Color match
Color match between repigmentation of the lesions and surrounding skin assessed subjectively by a blind investigator using digital photography at week 16 as follows:
No repigmentation color Lighter than peri lesion skin color Same as peri lesion skin color Darker than peri lesion skin color
Measured: 4 months
Secondary outcomes (1)
Complication
Complication at the location of melanocyte donor and recipient both from the two procedure include secondary infection, milia, scar tissue, rejection, and new vitiligo lesion (Köebnerization) on the donor or recipient site of NCEHFORSCS transplantation and cobblestone appearance at the recipient area of MPG and minimal superficial scar tissue at the MPG donor area.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Dec 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Segmental 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reiva Farah Dwiyana, MD, Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619184
- Sponsor's protocol ID
- DV-202407.01.
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effectiveness Between Transplantation of Autologous Non-Cultured Extracted Hair Follicle Outer Root Sheath Cell Suspension and Mini Punch Graft in Non-Segmental Vitiligo
- ClinicalTrials.gov ID
- NCT06619184
- Acronym / sponsor ID
- DV-202407.01.
- Conditions
- Non Segmental Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Oct 2024 (actual)
- 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.
Vitiligo is an acquired pigmentation disorder due to loss of melanocytes characterized by depigmentation macules or patches. One type of this disease is nonsegmental vitiligo (NSV). Until now, there is no satisfactory treatment for vitiligo. Vitiligo therapies are medical therapy include topical and systemic therapy, phototherapy as well as surgery. Surgical treatment is indicated in stable vitiligo, which is not responding to medical treatment. This procedure consists of tissue grafting and cellular transplantation. Mini punch graft (MPG) is the most frequently performed tissue transplantation technique, while cellular transplantation from autologous noncultured extracted hair follicle outer root sheath cell suspension (NCEHFORSCS) containing melanocyte stem cells, is currently a promising option.
Detailed description
Current NSV treatments can be considered suboptimal and leading to decreased patient's quality of life due to the emotional burden of therapy dissatisfaction. When a stable NSV is not responding to medical therapy, surgery may be a useful treatment approach. All surgical techniques in vitiligo treatment share the same principle: transferring autologous melanocytes from a donor to repopulate melanocytes in the depigmented area that lacks a reservoir or fails to activate melanocytes in the outer root sheath (ORS) of hair follicles. MPG as the most frequently performed tissue transplantation technique transferred the epidermal melanocyte to vitiligo lesion, while NCEHFORSCS provides melanocytes with better properties and contains melanocyte stem cells. The advantages of melanocytes from ORS compared to epidermal are the follicular melanocyte:keratinocyte ratio consists of one melanocyte for every five keratinocytes or 1:5 in the hair bulb, melanocytes are more dendritic, have larger melanosomes, and have the potential to produce more melanin pigment. Due to these properties, hair follicles can be a better source of melanocytes than epidermis in the delivery of cellular transplantation-based therapy for vitiligo therapy. Research comparing the effectiveness of the two procedures has never been conducted in Indonesia, even though the incidence of vitiligo is quite high and the success of therapy is still not optimal. So the purpose of this study is to compare the effectiveness of the two procedures in NSV patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NCEHFORSCS transplantation and MPG procedure | Experimental | Procedure: NCEHFORSCS transplantation, Procedure: MPG procedureThe research was conducted on 21 participants. Two vitiligo lesions from each participant that met the inclusion and exclusion criteria were treated with NCEHFORSCS transplantation and MPG procedure followed by observation of repigmentation. The participants were informed that a series of procedures would be performed, including hair follicle extraction using the follicle unit extraction (FUE) procedure, followed by the preparation of NCEHFORSCS in PT Prodia StemCell Indonesia (ProSTEM®) laboratory, and transplantation of NCEHFORSCS on one VNS lesion while MPG procedure was performed on another lesion. Follow-up was carried out at the 2nd week, 4th week, 8th week, 12th week, and 16th week after the NCEHFORSCS transplantation and MPG procedures to assess repigmentation of the lesions and side effects of the procedures. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Non-Segmental Vitiligo patients
- Minimal 1-year duration of stability
- Age between 18-70 years
- Having at least two vitiligo lesions for NCEHFORSCS transplantation and MPG procedure
- Have similar size, minimum of 1 cm² and a maximum of 20 cm²
Key exclusion criteria (8 listed)
- Pregnant
- Active vitiligo
- Mixed vitiligo
- Presence of new lesions
- History of hypertrophic scars and keloids
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 |
|---|---|---|
| NCEHFORSCS transplantationOne vitiligo lesion of participans treated with NCEHFORSCS transplantation including follicle unit extraction (FUE) procedure from the occipital area, laboratory procedure for preparation of cell suspension, and transplantation of NCEHFORSCS. | Procedure or surgery | NCEHFORSCS transplantation and MPG procedure |
| MPG procedureAnother vitiligo lesion treated with MPG procedure Follow up The dressing was removed by the researcher on day 8 The participants were asked to attend for follow-up at the clinic on week 2, 4, 8, 12, and 16 after the two procedure were done. At 2, 4, 8, 12 and 16 weeks of follow-up visits, any possible complications were evaluated and digital photographs of the lesions were taken for evaluating the two procedure efficacy using its parameter: appearance of repigmentation (AOR), total number of repigmentation NSV lesions, extent area of repigmentation, and color match | Procedure or surgery | NCEHFORSCS transplantation and MPG procedure |
Primary outcome
Appearance of repigmentation (AOR)
Time frame: 4 months
The first appearance of repigmentation in non-segmental vitiligo (NSV) lesions after NCEHFORSCS transplantation and MPG procedure evaluated by blind investigator using dermoscope at weeks 2, -4, -8, -12, and -16
Total number of repigmentation non-segmental vitiligo (NSV) lesions
Time frame: 4 months
Total number of NSV lesions that experienced repigmentation at the 16th week of observation
Extent area of repigmentation
Time frame: 4 months
The repigmentation area percentage level of non-segmental vitiligo (NSV) lesions after NCEHFORSCS transplantation and MPG procedure determine by blind investigator using the digital images. The scores were confirmed by objective measurement of the extent of repigmentation by a digital image analysis system ImageJ® as follow: No repigmentation (0%) Poor repigmentation (0,1-49%) Fair repigmentation (50-74%) Good repigmentation (75-89%) Excellent repigmentation (90-100%)
Color match
Time frame: 4 months
Color match between repigmentation of the lesions and surrounding skin assessed subjectively by a blind investigator using digital photography at week 16 as follows: No repigmentation color Lighter than peri lesion skin color Same as peri lesion skin color Darker than peri lesion skin color
1 secondary outcome
Complication
Time frame: 4 months
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 4 Oct 2024.
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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.
Reiva Farah Dwiyana, MD principal investigator
Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NCEHFORSCS transplantation and MPG procedure in people with Non Segmental Vitiligo, run by Universitas Padjadjaran at 1 site in Indonesia.
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 9 inclusion and 8 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 4 Oct 2024. 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 Indonesia. 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?
Appearance of repigmentation (AOR) (time frame: 4 months). The study lists 4 primary outcomes in all. 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 4 Oct 2024.