VitiligoNCT03717025
Comparison of Surgical Methods on Resistant Sites in Stable Vitiligo Patients
A study testing SUCTION BLISTER EPIDERMAL GRAFTING, MINI PUNCH GRAFTING and NON CULTURED EPIDERMAL CELL SUSPENSION in people with Vitiligo, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Comparing the Efficacy of Three Different Surgical Methods on Resistant Sites in Stable Vitiligo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- SUCTION BLISTER EPIDERMAL GRAFTING, MINI PUNCH GRAFTING and NON CULTURED EPIDERMAL CELL SUSPENSION
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2017to Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with clinical diagnosis of focal, segmental or generalized vitiligo
- Patients with lesions of size > 1.5cm x 1cm present on acral areas and bony prominences.
- Vitiligo lesions has been stable for 1 year.
- Disease not responding to medical treatment, or there are residual patches (after medical therapy) of vitiligo which inturn are located on acral areas and bony prominences.
- Maximum size of vitiligo patches to be selected for surgery will not be >100cm2.
Who cannot join
- Age less than 18 years
- Pregnancy and lactation
- Patient with actively spreading vitiligo
- History of Koebnerisation
- History of hypertrophic scars or keloidal tendency
- Bleeding disorders
- Patients with unrealistic expectation
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
MUTHU SENDHIL KUMARAN, ASSOCIATE PROFESSOR, 9876930521 ext. 91, drsen_2000@yahoo.com
AMIT KUMAR, JUNIOR RESIDENT, 7347638076 ext. 91, amitdalla615@gmaiil.com
About this study
Official title: A Comparative Study Between Autologous Mini Punch Grafting, Suction Blister Grafting and Non-Cutured Epidermal Cell Suspension on Resistant Sites in Stable Vitiligo
Comparing the Efficacy of Three Different Surgical Methods on Resistant Sites in Stable Vitiligo.
Read the detailed description
The treatment of vitiligo includes both medical and surgical modalities, whose goal is to restore melanocytes to the depigmented skin so that the epidermis restores back to normal morphology and functions. Although medical treatment is the main stay of treatment, it is not effective in all and residual lesions need augmented surgical treatment later for further completion of repigmentation.
Now a day surgical modalities have become treatment of choice for stable vitiligo not responding to medical treatment although there are numerous sites which do not respond that well to surgical procedure as well. The investigators ought to compare the efficacy of 3 well established surgical methods i.e. Mini Punch Grafting vs Suction Blister Epidermal Grafting vs Non Cultured Epidermal cell Suspension on stable vitiligo patches localized to acral areas and bony prominences like elbows, knees and ankles. Out of all the vitiligo patches in a given participant, 3 different patches on acral and bony areas will be chosen and participants will be treated with 3 different methods.
- Conditions
- Vitiligo
- Being tested
- SUCTION BLISTER EPIDERMAL GRAFTING, MINI PUNCH GRAFTING, NON CULTURED EPIDERMAL CELL SUSPENSION
- Keywords
- ACRAL
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUCTION BLISTER EPIDERMAL GRAFTINGProcedure or surgery
- Preferred donor sites for making blister is lateral aspect of upper thigh. The area is shaved and cleansed with surgical spirit.
- Blister formation is induced by using suction apparatus.
- Recipient site is surgically prepared by doing dermabrasion.
- After formation of blisters, each blister is gently cleansed with normal saline and cut all along its border with curved iris scissors parallel to the skin surface. The roof is everted over the thumb with dermal surface facing upwards and then with the help of blunt end of forceps it is placed on the recipient area.
- The graft is firmly pressed with sterile moist gauze to remove any underneath serous collection.
- The pressure dressing is done with double layer framycetin tulle, moist gauze and bandage.
- Donor area is dressed with dry sterile pads.
- The part is immobilized and Antibiotics and Analgesic are given till dressing are removed (after 5-7 days).
MINI PUNCH GRAFTINGProcedure or surgery
- Recipient area is prepared first after shaving and cleaning with surgical spirit. 2 % lignocaine with or without adrenalin will be infiltrated as local aneasthetic.
- The punched out chambers are spaced at a gap of less than 5 mm (preferably 2 - 2.5 mm) from each other.
- The donor area is either upper lateral portion of thigh or gluteal region.
- Grafts are placed directly from donor to the recipient area. Care is taken, so that graft edges are not folded, the tissue is not crushed or placed upside down.
- Hemostasis is achieved by pressing a saline soaked gauze piece over the area.
- For the recipient area 3 layers of dressing from inside out are : paraffin embedded non adherent sterile gauze, sterile surgipad, and micropore.
- For the donor area only surgipad and micropore are used.
- Immobilisation of recipient area is advised along with antibiotics and analgesics till removal of dressing (after 4-7 days).
NON CULTURED EPIDERMAL CELL SUSPENSIONProcedure or surgery
- About one-tenth the size of recipient area is selected as the donor site.
- Split thickness skin graft is taken under aseptic precautions with the help of a shaving blade held firmly by a straight artery forceps.
- The area is dressed with Bactigras gauze.
- Split thickness skin specimen is transferred under aseptic conditions to a container with Normal Saline and transferred to laboratory for preparing suspension.
- Recipient site is dermabraded under aseptic precautions until tiny pinpoint bleeding spots are seen.
- Epidermal cell suspension is carefully transferred to a tuberculin syringe.
- With 18 gauge needle attached to this syringe, suspension is spread evenly on dermabraded recipient site.
- This is then covered with Collagen dressing, followed by bactigras, guaze and tegaderm dressings from inside to outside.
- The patient is observed for 2 hours after performing the procedure and given antibiotics and analgesics for 5-7 days till dressing removal.
| Study group | Role | What they receive |
|---|---|---|
| Mini Punch Grafting | Active comparator | Not described Receives: Procedure: MINI PUNCH GRAFTING |
| Suction Blister Epidermal Grafting | Active comparator | Not described Receives: Procedure: SUCTION BLISTER EPIDERMAL GRAFTING |
| Non Cultured Epidermal Cell Suspension | Active comparator | Not described Receives: Procedure: NON CULTURED EPIDERMAL CELL SUSPENSION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation At Surgery Site
To assess the difference in extent of repigmentation of the surgery site by three different methods at 12 weeks of post treatment follow up in a given patient.
Repigmentation will be assessed as follows:
≤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation >90% Excellent repigmentation
Measured: Repigmentation will be assessed at 12 weeks.
Secondary outcomes (5)
Color Matching of Repigmented Area
Color matching of the repigmented area with the surrounding normal skin will be done in each case as 'somewhat lighter than', 'same as' or 'somewhat darker than' normal skin.
Measured: Assessment at 12 weeks.
Patient's Quality of Life Post Surgery
Patient satisfaction will be assessed using Patient Global Assessment score.
Measured: Assessment at 12 weeks.
Patient's Quality of Life Post Surgery
Quality of life assessement post procedure will be done using Vitiligo specific questionnaire.
Measured: Assessment at 12 weeks.
PATTERN OF REPIGMENTATION
Pattern of repigmentation attained post-procedure will be noted as 'diffuse', 'perifollicular' or 'migrating from the borders'.
Measured: Assessment at 12 weeks.
ADVERSE EVENTS
Adverse events both at recipient and donor sites.
Measured: Assessment at 4, 8 and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Jul 2017
- Primary completionOct 2018 (estimated)
- Study completionNov 2018 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davinder Parsad, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717025
- Sponsor's protocol ID
- INT/IEC/2017/1251
- Status last verified
- Oct 2018
- First submitted
- 16 Oct 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Overall results of the study will be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Autologous Mini Punch Grafting, Suction Blister Grafting and Non-Cutured Epidermal Cell Suspension on Resistant Sites in Stable Vitiligo
- ClinicalTrials.gov ID
- NCT03717025
- Acronym / sponsor ID
- INT/IEC/2017/1251
- Conditions
- Vitiligo
- Keywords
- ACRAL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 23 Oct 2018 (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.
Comparing the Efficacy of Three Different Surgical Methods on Resistant Sites in Stable Vitiligo.
Detailed description
The treatment of vitiligo includes both medical and surgical modalities, whose goal is to restore melanocytes to the depigmented skin so that the epidermis restores back to normal morphology and functions. Although medical treatment is the main stay of treatment, it is not effective in all and residual lesions need augmented surgical treatment later for further completion of repigmentation.
Now a day surgical modalities have become treatment of choice for stable vitiligo not responding to medical treatment although there are numerous sites which do not respond that well to surgical procedure as well. The investigators ought to compare the efficacy of 3 well established surgical methods i.e. Mini Punch Grafting vs Suction Blister Epidermal Grafting vs Non Cultured Epidermal cell Suspension on stable vitiligo patches localized to acral areas and bony prominences like elbows, knees and ankles. Out of all the vitiligo patches in a given participant, 3 different patches on acral and bony areas will be chosen and participants will be treated with 3 different methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mini Punch Grafting | Active comparator | Procedure: MINI PUNCH GRAFTING |
| Suction Blister Epidermal Grafting | Active comparator | Procedure: SUCTION BLISTER EPIDERMAL GRAFTING |
| Non Cultured Epidermal Cell Suspension | Active comparator | Procedure: NON CULTURED EPIDERMAL CELL SUSPENSION |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with clinical diagnosis of focal, segmental or generalized vitiligo
- Patients with lesions of size > 1.5cm x 1cm present on acral areas and bony prominences.
- Vitiligo lesions has been stable for 1 year.
- Disease not responding to medical treatment, or there are residual patches (after medical therapy) of vitiligo which inturn are located on acral areas and bony prominences.
- Maximum size of vitiligo patches to be selected for surgery will not be >100cm2.
Key exclusion criteria (7 listed)
- Age less than 18 years
- Pregnancy and lactation
- Patient with actively spreading vitiligo
- History of Koebnerisation
- History of hypertrophic scars or keloidal tendency
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 |
|---|---|---|
| SUCTION BLISTER EPIDERMAL GRAFTING1. Preferred donor sites for making blister is lateral aspect of upper thigh. The area is shaved and cleansed with surgical spirit. 2. Blister formation is induced by using suction apparatus. 3. Recipient site is surgically prepared by doing dermabrasion. 4. After formation of blisters, each blister is gently cleansed with normal saline and cut all along its border with curved iris scissors parallel to the skin surface. The roof is everted over the thumb with dermal surface facing upwards and then with the help of blunt end of forceps it is placed on the recipient area. 5. The graft is firmly pressed with sterile moist gauze to remove any underneath serous collection. 6. The pressure dressing is done with double layer framycetin tulle, moist gauze and bandage. 7. Donor area is dressed with dry sterile pads. 8. The part is immobilized and Antibiotics and Analgesic are given till dressing are removed (after 5-7 days). | Procedure or surgery | Suction Blister Epidermal Grafting |
| MINI PUNCH GRAFTING1. Recipient area is prepared first after shaving and cleaning with surgical spirit. 2 % lignocaine with or without adrenalin will be infiltrated as local aneasthetic. 2. The punched out chambers are spaced at a gap of less than 5 mm (preferably 2 - 2.5 mm) from each other. 3. The donor area is either upper lateral portion of thigh or gluteal region. 4. Grafts are placed directly from donor to the recipient area. Care is taken, so that graft edges are not folded, the tissue is not crushed or placed upside down. 5. Hemostasis is achieved by pressing a saline soaked gauze piece over the area. 6. For the recipient area 3 layers of dressing from inside out are : paraffin embedded non adherent sterile gauze, sterile surgipad, and micropore. 7. For the donor area only surgipad and micropore are used. 8. Immobilisation of recipient area is advised along with antibiotics and analgesics till removal of dressing (after 4-7 days). | Procedure or surgery | Mini Punch Grafting |
| NON CULTURED EPIDERMAL CELL SUSPENSION1. About one-tenth the size of recipient area is selected as the donor site. 2. Split thickness skin graft is taken under aseptic precautions with the help of a shaving blade held firmly by a straight artery forceps. 3. The area is dressed with Bactigras gauze. 4. Split thickness skin specimen is transferred under aseptic conditions to a container with Normal Saline and transferred to laboratory for preparing suspension. 5. Recipient site is dermabraded under aseptic precautions until tiny pinpoint bleeding spots are seen. 6. Epidermal cell suspension is carefully transferred to a tuberculin syringe. 7. With 18 gauge needle attached to this syringe, suspension is spread evenly on dermabraded recipient site. 8. This is then covered with Collagen dressing, followed by bactigras, guaze and tegaderm dressings from inside to outside. 9. The patient is observed for 2 hours after performing the procedure and given antibiotics and analgesics for 5-7 days till dressing removal. | Procedure or surgery | Non Cultured Epidermal Cell Suspension |
Primary outcome
Repigmentation At Surgery Site
Time frame: Repigmentation will be assessed at 12 weeks.
To assess the difference in extent of repigmentation of the surgery site by three different methods at 12 weeks of post treatment follow up in a given patient. Repigmentation will be assessed as follows: ≤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation >90% Excellent repigmentation
5 secondary outcomes
Color Matching of Repigmented Area
Time frame: Assessment at 12 weeks.
Patient's Quality of Life Post Surgery
Time frame: Assessment at 12 weeks.
Patient's Quality of Life Post Surgery
Time frame: Assessment at 12 weeks.
PATTERN OF REPIGMENTATION
Time frame: Assessment at 12 weeks.
ADVERSE EVENTS
Time frame: Assessment at 4, 8 and 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: Undecided. Overall results of the study will be available to other researchers.
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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.
Post Graduate Institute of Medical Education and Research
Chandigarh, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUCTION BLISTER EPIDERMAL GRAFTING, MINI PUNCH GRAFTING and NON CULTURED EPIDERMAL CELL SUSPENSION in people with Vitiligo, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 7 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: status not confirmed, as of the sponsor's last update on 23 Oct 2018. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repigmentation At Surgery Site (time frame: Repigmentation will be assessed at 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 23 Oct 2018.