CTRI Number |
CTRI/2022/02/040232 [Registered on: 11/02/2022] Trial Registered Prospectively |
Last Modified On: |
03/02/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A STUDY BETWEEN RECEPIENT SITE PREPARATION USING MANUAL DERMABRASION AND TATTOOING PEN IN AUTOLOGOUS NON CULTURED EPIDERMAL CELL SUSPENSION PROCEDURE IN STABLE VITILIGO PATIENTS: A RANDOMIZED DOUBLE BLINDED STUDY |
Scientific Title of Study
|
A COMPARATIVE STUDY BETWEEN RECEPIENT SITE PREPARATION USING MANUAL DERMABRASION AND TATTOOING PEN IN AUTOLOGOUS NON CULTURED EPIDERMAL CELL SUSPENSION PROCEDURE IN STABLE VITILIGO PATIENTS: A RANDOMIZED DOUBLE BLINDED STUDY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Akshay Meena |
Designation |
junior resident |
Affiliation |
PGIMER Chandigarh |
Address |
Room no.3, level 2D, Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012 Madhya Marg, Sector 12, Chandigarh, 160012 Chandigarh CHANDIGARH 160012 India |
Phone |
09003989552 |
Fax |
|
Email |
akshaymeena669@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Davinder parsad |
Designation |
professor |
Affiliation |
PGIMER Chandigarh |
Address |
Room no.3, level 2D, Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012 sector 12 Chandigarh CHANDIGARH 160012 India |
Phone |
9876060361 |
Fax |
|
Email |
parsad@me.com |
|
Details of Contact Person Public Query
|
Name |
Akshay Meena |
Designation |
junior resident |
Affiliation |
PGIMER Chandigarh |
Address |
Room no.3, level 2D, Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012 Madhya Marg, Sector 12, Chandigarh, 160012 Chandigarh CHANDIGARH 160012 India |
Phone |
09003989552 |
Fax |
|
Email |
akshaymeena669@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
PGIMER |
Address |
Sector 12
madhya marg, chandigarh
160012 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
AKSHAY MEENA |
PGIMER |
Room no.3, level 2D, Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012 Chandigarh CHANDIGARH |
09003989552
akshaymeena669@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
PGIMER |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
manual dermabration |
therapy once at week 0
follow up at 4,8,12,16,24 weeks |
Comparator Agent |
tattooing pen |
therapy once at week 0
follow up at 4,8,12,16,24 weeks |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1)Patients with a clinical diagnosis of segmental or non-segmental vitiligo and
2)Patients with two independent patches of size 3x3 cm or more present either symmetrically or unilaterally over same body site or patients with a single patch of 6 x 6 cm or more.
3)Vitiligo lesions have been stable for 1 year or more. Stability is defined as no progression of lesions for at least 1 year or more, with or without spontaneous repigmentation and absence of new koebner phenomenon.
4)Disease should have failed repigmentation with medical treatment, or there are residual patches (after medical therapy) of vitiligo.
5)Size of vitiligo patches <100cm2.
6)Wash off period of 4 weeks for topical therapy and 12 weeks for systemic therapy has passed
|
|
ExclusionCriteria |
Details |
1)Pregnancy and lactation
2)Patient with active disease i.e. VIDA 1+ or more
3)History of hypertrophic scars or keloidal tendency
4)Current skin infections at donor or recipient site
5) Patients with unrealistic expectations
6) History of bleeding disorders
7) Patients on anticoagulants
8) Immunosuppressed patients
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.The proportion of patients achieving 75% repigmentation at 24 weeks follow-up in both groups. |
24 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.The proportion of patients achieving 50% repigmentation at 24 weeks follow-up in both groups.
2.To assess the color matching of repigmented area.
3.To assess the patient satisfaction (patient global assessment) and to compare the quality of life assessement post procedure with that of pre procedure.
4.To monitor adverse events if any.
5.To compare the effect of recipient site preparation on acral vs non-acral areas.
|
24 weeks |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
25/02/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Vitiligo is a
common acquired disorder of depigmentation which occurs as a result of
melanocyte loss. While the prevalence of
vitiligo around the globe is around 1%, the prevalence in India goes up to
8.8%, making it a major proportion of patients seen in dermatology services.1
The dark complexion of a considerable size of our population combined with
social stigma and lack of knowledge about the disease in the general population
causes a lot of psychological distress to the patients.
Vitiligo is
characterized by milky or ivory white sharply demarcated macules, often
symmetrical on both sides of the body.
The size of the lesions may vary from a few millimetres to several
centimetres. The common sites of
predilection are areas of repeated trauma or chronic pressure or friction like
hips, dorsum of hands and feet, ankles, elbows and knees. The natural course of
the disease is highly unpredictable as well, with periods of abrupt onset,
active disease, then stability or repigmentation and rapid progression after a
period of dormancy.
Many theories
have been suggested for the etiopathogenesis of vitiligo: genetic, biochemical,
neural, autoimmune, defective free radical defence, deficiency of melanocyte
growth factors and an intrinsic defect of melanocyte adhesion.2
In spite of this, vitiligo still remains an idiopathic disorder, with more than
one factor at play in a single individual. It is also associated with a myriad
of autoimmune diseases with the most common one being thyroid disorders.
The cosmetic
disfigurement combined with the social stigma and lack of a uniformly effective
therapy calls for the development of newer and better treatment modalities.
Conventional medical therapies have used both topical and oral treatment. First
line therapies are usually topical steroids or topical calcineurin inhibitors like
tacrolimus and pimecrolimus, combined with ample and regular use of sunscreen.3
Oral mini pulse therapy using dexamethasone is used for rapidly progressive or active
disease and has shown to halt the disease activity and has caused
repigmentation in some patients.3
Other therapies like antioxidants, systemic phototherapy i.e. psoralen and
ultraviolet A (PUVA), ultraviolet B (UVB) therapy, laser therapy are also being
used.3
Response to these therapies, both conventional and novel, is variable in
individuals, often giving unsatisfactory results, especially in those with
acral lesions, with patients having to resort to cosmetic camouflage.
Surgical
therapies are indicated in patients with stable disease who fail to respond to
medical therapies. This mostly includes autologous grafting techniques both
tissue and cellular (both cultured and non-cultured).4
Cellular grafting techniques generally involve harvesting epithelial cells from
the donor sites and after proper preparation grafting them onto the recipient
sites with the aim of repopulating the depigmented area with melanocytes to
cause repigmentation.4
Recipient site preparation is needed to stimulate melanogenesis and melanocyte
proliferation. This step is crucial in determining the success of the
procedure, hence making it essential to study the various methods and know
about their efficacies. Common techniques of recipient site preparation include
dermabrasion, suction blistering, liquid nitrogen, electrofulguration,
microneedlig etc.5
Recipient site preparation using dermabrasion is one of the most widely used methods and includes
manual dermabrasion using Manekshaw’s dermabrader and motor dermabrasion. Manual dermabrasion is the
gold standard technique and is the standard of care followed in most centres.
Microneedling
was initially introduced for skin rejuvenation, however, this minimally
invasive procedure is now being used for the treatment of multiple dermatological
conditions. It is better than simple injection needle in controlling depth of
penetration and thus preventing excessive pain during injection.
It causes a
micro-inflammation in the epidermal layer which enhances melanocytes and
keratinocytes migration and stimulates repigmentation of vitiligo areas. We
propose to compare the outcome of microneedling assisted recipient site
preparation with the technique of conventional manual dermabrasion using
Manekshaw’s dermabrader in repigmentation
rates following non-cultured epidermal cell suspension. |