| CTRI Number |
CTRI/2022/04/041751 [Registered on: 08/04/2022] Trial Registered Prospectively |
| Last Modified On: |
11/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
OPEN LABELLED, SINGLE ARM, INTERVENTIONAL STUDY OF MICRO PUCH GRAFTING FOR VITILIGO. |
|
Scientific Title of Study
|
MICRO PUCH GRAFTING (MICRO PG) BY USING MOTORIZED POWER PUNCHES AS A TISSUE EXTRACTOR 0.8 MM IN STABLE AND LIP VITILIGO: A NOVEL APPROACH IN STABLE VITILIGO |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocon No:CACS-DS-001, Vesrion.01, Date:17 Jan 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madura C |
| Designation |
Lead Consultant Dermatosurgeon Hair Transplantation Surgeon and Consultant Dermatologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
5/1,4th Main, MRCR Layout
Vijayanagar, Bangalore Department of Dermatosurgery, Room No:10
5/1,4th Main, MRCR Layout
Vijayanagar, Bangalore Bangalore Rural KARNATAKA 560040 India |
| Phone |
|
| Fax |
|
| Email |
maduradr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madura C |
| Designation |
Lead Consultant Dermatosurgeon Hair Transplantation Surgeon and Consultant Dermatologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
5/1,4th Main, MRCR Layout
Vijayanagar, Bangalore Department of Dermatosurgery, Room No:10
5/1,4th Main, MRCR Layout
Vijayanagar, Bangalore Bangalore Rural KARNATAKA 560040 India |
| Phone |
|
| Fax |
|
| Email |
maduradr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madura C |
| Designation |
Lead Consultant Dermatosurgeon Hair Transplantation Surgeon and Consultant Dermatologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
5/1,4th Main, MRCR Layout
Vijayanagar, Bangalore Department of Dermatosurgery, Room No:10
5/1,4th Main, MRCR Layout
Vijayanagar, Bangalore Bangalore Rural KARNATAKA 560040 India |
| Phone |
|
| Fax |
|
| Email |
maduradr@gmail.com |
|
|
Source of Monetary or Material Support
|
| CUTIS Academy of Cutaneous Sciens 5/1,4th Main, MRCR layout, Vijayanagar, bangalore 560040 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Ravikumar S M |
CUTIS Academy of Cutaneous Sciences |
Department of dermatosurgery, Room No:10
5/1,4th Main, MRCR Layout
Vijayanagar, Bangalore Bangalore Rural KARNATAKA |
8660619504
ravism64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CUTIS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Micro punch grafting |
The patients were assessed every 15 days for 3 months and once a month for the next 3 months. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age > 15 years
2. The vitiligo stability of at least 12 months
3. Patient not responding to medical management |
|
| ExclusionCriteria |
| Details |
1. Unstable vitiligo
2. Tendency for hypertrophic and keloid scars
3. History of bleeding diathesis
4. Pregnancy and lactation
5. Active infection in Donor or recipient site |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the efficacy of repigmentation in stable lip Vitiligo by motorized motorized micro punch grafting technique |
After 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the Side effect profile of the motorized MPG technique |
After 3 months |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/04/2022 |
| Date of Study Completion (India) |
06/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/09/2022 |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
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 disorder of pigmentation.1 Pathogenetically, vitiligo represents a complex reaction
pattern involving multiple etiologic factors, some of them necessarily working
in concert. On-going research is focussing on a better understanding of
pathogenesis and thus searching for better treatment modalities. Treatment
is classified into medical, light-based, surgical, camouflage, and
depigmentation therapy2.
Surgical
treatment is generally considered when medical/light-based treatment has failed
and includes tissue transfer (e.g., punch grafting, partial split-thickness
grafting, and suction blister grafting) and cellular transfer, which is further
divided into cultured and non-cultured techniques.3-5 The basic principle of surgical treatment is
to transfer the melanocytes from normal skin to-vitiliginous skin. Non-cultured
epidermal cell suspension (NCES) is considered the standard and most effective
surgical treatment for stable vitiligo and, it along with suction blister
grafting (SBG), has a better outcome than other surgical methods.6
Autologous mini punch grafting is the easiest,
effective, and less expensive method of vitiligo surgery. It is indicated in
almost all sites especially in acral vitiligo involving palms, fingers, nipples,
and lips.7
The
technique of Mini punch grafting (MPG) has
undergone many modifications over the years to reduce the requirement for
equipment and to save time. The time
consumed in MPG using punches of less than 1.5 mm is more when compared with
punch grafting with 2-3 mm punches, moreover the number of grafts required is
also more with a decrease in punch sizes. With the advent of motorized power
punches the procedure can be done with more ease in lesser time to harvest more
mini grafts (<1.5 mm) in a single session.7
A newer technique of Motorized 0.8-mm micro punch
grafting for refractory vitiligo from a retrospective study of 230 cases
concluded that refractory vitiligo
with short procedure times had an excellent outcome. This technique could be a
rapid and convenient surgical option with acceptable adverse events and is
promising for treating refractory vitiligo on an outpatient basis, particularly
in patients who are unlikely to tolerate prolonged surgery.8
We
also want to know the efficacy of the same by doing it in the exclusive lip
vitiligo and to look at the adverse effects of the 0.8mm micro punch
grafting. |