Non Segmental Vitiligo
Conditions
Brief 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. 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.
Interventions
PROCEDURENCEHFORSCS transplantation
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.
PROCEDUREMPG procedure
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
Sponsors
Universitas Padjadjaran
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Non-Segmental Vitiligo patients 2. Minimal 1-year duration of stability 3. Age between 18-70 years 4. Having at least two vitiligo lesions for NCEHFORSCS transplantation and MPG procedure The two vitiligo lesions to be treated must meet the following criteria: 1. Have similar size, minimum of 1 cm² and a maximum of 20 cm² 2. The distance between the two lesions at least 1 cm 3. Location of the lesions must have a relatively similar distribution of hair follicles 4. Not located on the palms, soles, or penis
Exclusion criteria
1. Pregnant 2. Active vitiligo 3. Mixed vitiligo 4. Presence of new lesions 5. History of hypertrophic scars and keloids 6. History of bleeding disorders 7. Other active autoimmune diseases 8. History of wound healing disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Appearance of repigmentation (AOR) | 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 | 4 months | Total number of NSV lesions that experienced repigmentation at the 16th week of observation |
| Extent area of repigmentation | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication | 4 months | 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. |
Countries
Indonesia
Outcome results
None listed