VitiligoNCT03872804
Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo
A study testing Autologous punch mini grafts:, Transverse needling and Punch minigrafts followed by transverse needling in people with Vitiligo, run by Alexandria University at 1 site in Egypt.
Trial summary
This study is to evaluate the effectiveness and tolerability of autologous punch minigraft, transverse needling technique or combination of both followed by narrow band ultraviolet B phototherapy (311 nm) in the treatment of patients with stable non-segmental vitiligo lesions. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Autologous punch mini grafts:, Transverse needling and Punch minigrafts followed by transverse needling
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 Mar 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients (>16 years old) of either gender having stable non segmental vitiligo, that is resistant to other lines of repigmentation therapy.
- Lack of progression of old lesions with the past 6 months.
- No development of new lesions
- Absence of history of koebner phenomenon.
- Absence of confetti lesions or hypopigmented lesions within the past 6 months.
- Presence of repigmentation of depigmented areas by medications or spontaneously in the past 6 months.
- While resistance to therapy will be judged after receiving standard protocol of NB-UVB together with oral mini pulse dexamethasone at a dose of 2.5 mg on two consecutive weekly days for 3 months.
- Patients having lesions showing absence or poor repigmentation after this regiment will be considered resistant to medical repigmentation and indicated to surgery.
Who cannot join
- Cases of active, progressive disease lacking criteria of stability previously mentioned.
- Patients with segmental or universal vitiligo covering more than 70% body surface area.
- Patients with known associated autoimmune diseases, bleeding tendency, current or history of skin neoplasia, photosensitive disorders or any contraindications to corticosteroids therapy.
- Patients with tendency towards hypertrophic scars or keloid formation.
- Pregnant female and lactating mothers.
- Patients with emotional and psychological instability.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Omneya abd el aziz el zagh
Alexandria, 21500
Omneya El zagh, +201142955011, Dr.omneya.zagh@gmail.com
Carmen Farid amin, Professor
About this study
This study is to evaluate the effectiveness and tolerability of autologous punch minigraft, transverse needling technique or combination of both followed by narrow band ultraviolet B phototherapy (311 nm) in the treatment of patients with stable non-segmental vitiligo lesions.
Read the detailed description
Vitiligo is a common pigmentary cutaneous disorder occurring with an incidence of 1-2% worldwide, without predilection for sex or race.
The disease is characterized by gradual loss of the normal color of the skin resulting from melanin pigment loss due to the underlying destruction of the melanocyte.
Vitiligo is a multifactorial disorder with many theories explaining its pathogenesis such as autoimmunity, self-destructing mechanisms,neural mediators, biochemicals,an imbalance of epidermal cytokines and genetic factors.
Vitiligo is not a life-threatening disease,but it may cause a major social and emotional distress with significant impairment in the quality of life.
Clinically; vitiligo is classified into segmental, non-segmental and unclassified vitiligo .Non-segmental includes generalized, acrofacial,universal, mucosal (more than one mucosal site) , mixed (associated with segmental vitiligo) and other rare variants. Segmental vitiligo includes uni- ,bi- or pluri-segmental subtypes. Unclassified includes focal or mucosal (one site) subtypes.
Treatment options for vitiligo include attempting repigmentation of affected areas,
depigmentation of non-involving skin or camouflage if neither is effective.Repigmentation could be attempted using medical therapy, surgical modalities.
Topical medications include corticosteroids or calcineurin inhibitors.Ultraviolet radiation therapy, such as narrow-band ultraviolet B light (NB-UVB), is also widely used. It is minimally invasive, has few adverse effects and provides a good response rate. Excimer laser or light has become available for use recently, and favorable treatment results have been reported.
When medical treatments are ineffective, surgical treatment is indicated.
- Conditions
- Vitiligo
- Being tested
- Autologous punch mini grafts:, Transverse needling, Punch minigrafts followed by transverse needling, Oral pulse steroid with narrow band
- Keywords
- Vitiligo, Punch graft, Oral pulse steroid, Transverse needling
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous punch mini grafts:Procedure or surgery
Under local anesthesia, multiple 1mm holes will be made in the depigmented treatment area using 1mm punch graft instrument inserted to a depth of 2-4 mm to remove a small column of depigmented skin that is to be discarded. The punches will be situated at or very close to the border of the lesion to avoid leaving an achromic fissure and will be separated by 5-8 mm distance from each other.
On the donor area mostly is the gluteal area, punches will be harvested using the same sized punches very close to each other so that maximum number of grafts can be taken from a small area.
Then the harvested-punch minigrafts will be inserted into the recipient chambers, pressed firmly by saline soaked gauge for hemostasis and secured by sterile strips or a compression bandage if applicable.
Transverse needlingProcedure or surgery
Needling will be done for selected treatment patch using a 30 G disposable insulin syringe, going from the pigmented margins of the lesion into the vitiliginous patch, Position of the needle will be kept close to the dermoepidermal junction and movement will be from normal skin towards the lesion. Needle pricks may lead to oozing of a small drop of blood which will be managed by physical pressure. No dressings will be needed. The procedure will be repeated for selected lesions weekly for a duration of 3 months.
Punch minigrafts followed by transverse needlingProcedure or surgery
In a third lesion, punch minigrafts will be done as mentioned in line 1 and will be left to stabilize for 3 months then transverse needling will be done weekly for the margins of the lesion as well as the areas of the punch grafts toward the vitiliginous area.
Oral pulse steroid with narrow bandOther
- A fourth lesion will be chosen as a control lesion, to which no surgical treatment will ba attempted.
- All lesions will receive NB-UVB therapy according to standard protocol twice weekly and the patients will continue on the oral mini pulse dexamethasone at 2.5 mg dose for two consecutive days weekly all through the study period
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo patient | Experimental | Patient has at least 4 patches , one of them will be treated by autologous punch graft , second one by transverse needling , third one with minigraft followed by needling , fourth one as control under treatment with oral pulse steroid with narrow band . Receives: Procedure: Autologous punch mini grafts:; Procedure: Transverse needling; Procedure: Punch minigrafts followed by transverse needling; Other: Oral pulse steroid with narrow band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of repigmentation
Assessments of repigmentation will be performed by two blinded dermatologists using a 5-point scale; grade 0 (no repigmentation), grade 1 (1%-5%), grade 2 (6%-25%), grade 3 (26%-50%), grade 4 (51%-75%) and grade 5 (76%-100%)
Measured: 6 months
Evaluation of Type, pattern and extent of repigmentation.
Serial photography will be done to evaluate type, pattern and extent of repigmentation.
Measured: 6 months
Digital assessment of the size of the lesion and of the depigmented versus repigmented area
Digital assessment of the size of the lesion and of the depigmented versus repigmented area using Adobe photoshop software
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Feb 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (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.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omneya abd el aziz abd el rehim el zagh, Alexandria University
- Investigators
- Carmen Ibrahiem farid amin, Ph.D, Study director, Assistant Professor of dermatolog Faculty of Medicine. University of Alexandria.Magdy Abd el aziz ragab, Ph.D, Study director, Professor of Dermatlolgy, Faculty of Medicine. University of Alexandria.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872804
- Sponsor's protocol ID
- AlexandriadermaU
- Status last verified
- Jan 2021
- First submitted
- 6 Mar 2019
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo
- ClinicalTrials.gov ID
- NCT03872804
- Acronym / sponsor ID
- AlexandriadermaU
- Conditions
- Vitiligo
- Keywords
- Vitiligo, Punch graft, Oral pulse steroid, Transverse needling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 13 Mar 2019 (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.
This study is to evaluate the effectiveness and tolerability of autologous punch minigraft, transverse needling technique or combination of both followed by narrow band ultraviolet B phototherapy (311 nm) in the treatment of patients with stable non-segmental vitiligo lesions.
Detailed description
Vitiligo is a common pigmentary cutaneous disorder occurring with an incidence of 1-2% worldwide, without predilection for sex or race.
The disease is characterized by gradual loss of the normal color of the skin resulting from melanin pigment loss due to the underlying destruction of the melanocyte.
Vitiligo is a multifactorial disorder with many theories explaining its pathogenesis such as autoimmunity, self-destructing mechanisms,neural mediators, biochemicals,an imbalance of epidermal cytokines and genetic factors.
Vitiligo is not a life-threatening disease,but it may cause a major social and emotional distress with significant impairment in the quality of life.
Clinically; vitiligo is classified into segmental, non-segmental and unclassified vitiligo .Non-segmental includes generalized, acrofacial,universal, mucosal (more than one mucosal site) , mixed (associated with segmental vitiligo) and other rare variants. Segmental vitiligo includes uni- ,bi- or pluri-segmental subtypes. Unclassified includes focal or mucosal (one site) subtypes.
Treatment options for vitiligo include attempting repigmentation of affected areas,
depigmentation of non-involving skin or camouflage if neither is effective.Repigmentation could be attempted using medical therapy, surgical modalities.
Topical medications include corticosteroids or calcineurin inhibitors.Ultraviolet radiation therapy, such as narrow-band ultraviolet B light (NB-UVB), is also widely used. It is minimally invasive, has few adverse effects and provides a good response rate. Excimer laser or light has become available for use recently, and favorable treatment results have been reported.
When medical treatments are ineffective, surgical treatment is indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitiligo patient | Experimental | Procedure: Autologous punch mini grafts:, Procedure: Transverse needling, Procedure: Punch minigrafts followed by transverse needling, Other: Oral pulse steroid with narrow bandPatient has at least 4 patches , one of them will be treated by autologous punch graft , second one by transverse needling , third one with minigraft followed by needling , fourth one as control under treatment with oral pulse steroid with narrow band . |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients (>16 years old) of either gender having stable non segmental vitiligo, that is resistant to other lines of repigmentation therapy.
- Lack of progression of old lesions with the past 6 months.
- No development of new lesions
- Absence of history of koebner phenomenon.
- Absence of confetti lesions or hypopigmented lesions within the past 6 months.
Key exclusion criteria (6 listed)
- Cases of active, progressive disease lacking criteria of stability previously mentioned.
- Patients with segmental or universal vitiligo covering more than 70% body surface area.
- Patients with known associated autoimmune diseases, bleeding tendency, current or history of skin neoplasia, photosensitive disorders or any contraindications to corticosteroids therapy.
- Patients with tendency towards hypertrophic scars or keloid formation.
- Pregnant female and lactating mothers.
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 |
|---|---|---|
| Autologous punch mini grafts:Under local anesthesia, multiple 1mm holes will be made in the depigmented treatment area using 1mm punch graft instrument inserted to a depth of 2-4 mm to remove a small column of depigmented skin that is to be discarded. The punches will be situated at or very close to the border of the lesion to avoid leaving an achromic fissure and will be separated by 5-8 mm distance from each other. On the donor area mostly is the gluteal area, punches will be harvested using the same sized punches very close to each other so that maximum number of grafts can be taken from a small area. Then the harvested-punch minigrafts will be inserted into the recipient chambers, pressed firmly by saline soaked gauge for hemostasis and secured by sterile strips or a compression bandage if applicable. | Procedure or surgery | Vitiligo patient |
| Transverse needlingNeedling will be done for selected treatment patch using a 30 G disposable insulin syringe, going from the pigmented margins of the lesion into the vitiliginous patch, Position of the needle will be kept close to the dermoepidermal junction and movement will be from normal skin towards the lesion. Needle pricks may lead to oozing of a small drop of blood which will be managed by physical pressure. No dressings will be needed. The procedure will be repeated for selected lesions weekly for a duration of 3 months. | Procedure or surgery | Vitiligo patient |
| Punch minigrafts followed by transverse needlingIn a third lesion, punch minigrafts will be done as mentioned in line 1 and will be left to stabilize for 3 months then transverse needling will be done weekly for the margins of the lesion as well as the areas of the punch grafts toward the vitiliginous area. | Procedure or surgery | Vitiligo patient |
| Oral pulse steroid with narrow band* A fourth lesion will be chosen as a control lesion, to which no surgical treatment will ba attempted. * All lesions will receive NB-UVB therapy according to standard protocol twice weekly and the patients will continue on the oral mini pulse dexamethasone at 2.5 mg dose for two consecutive days weekly all through the study period | Other | Vitiligo patient |
Primary outcome
Assessment of repigmentation
Time frame: 6 months
Assessments of repigmentation will be performed by two blinded dermatologists using a 5-point scale; grade 0 (no repigmentation), grade 1 (1%-5%), grade 2 (6%-25%), grade 3 (26%-50%), grade 4 (51%-75%) and grade 5 (76%-100%)
Evaluation of Type, pattern and extent of repigmentation.
Time frame: 6 months
Serial photography will be done to evaluate type, pattern and extent of repigmentation.
Digital assessment of the size of the lesion and of the depigmented versus repigmented area
Time frame: 6 months
Digital assessment of the size of the lesion and of the depigmented versus repigmented area using Adobe photoshop software
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Carmen Ibrahiem farid amin, Ph.D study director
Assistant Professor of dermatolog Faculty of Medicine. University of Alexandria.
Magdy Abd el aziz ragab, Ph.D study director
Professor of Dermatlolgy, Faculty of Medicine. University of Alexandria.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous punch mini grafts:, Transverse needling and Punch minigrafts followed by transverse needling in people with Vitiligo, run by Alexandria University at 1 site in Egypt.
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 8 inclusion and 6 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 19 Jan 2021. 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 Egypt. 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?
Contact Omneya El zagh, MBBCh (+201142955011, Dr.omneya.zagh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of repigmentation (time frame: 6 months). The study lists 3 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 19 Jan 2021.