VitiligoPhase 1NCT02510651
Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo
A Phase 1 study testing Melanocyte-keratinocyte suspension in people with Vitiligo, run by Cairo University.
Trial summary
ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant repigmentation did not show significant difference with better healing of the donor site. Compared to cryoblebs, CO2 gave more homogenous pigmentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Melanocyte-keratinocyte suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2014
- Phase
- Phase 1
- 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
- Stable non-segmental vitiligo
Who cannot join
- Active vitiligo
About this study
Official title: Effect of Procedural-Related Variables on Melanocyte-Keratinocyte Suspension Transplantation in Non-Segmental Stable Vitiligo: A Clinical and Immunohistochemical Study
ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant repigmentation did not show significant difference with better healing of the donor site. Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better results using combination of donor NCECS and recipient cryoblebs.
Read the detailed description
Background: Melanocyte-keratinocyte suspension (M-K susp) is gaining popularity for vitiligo treatment. Few studies have addressed procedure-related variables.
Objective: To assess the effect of different M-K susp procedure-related variables on the clinical outcome in stable vitiligo.
Methods: This retrospective study included 40 cases with stable non-segmental vitiligo treated by M-K susp followed by narrow band- ultraviolet B phototherapy twice weekly. Donor site was either a skin graft in non-cultured epidermal cell suspension (NCECS) (34 cases) or hair follicle unit in Outer Root Sheath Hair Follicle Suspension (ORSHFS) (6 cases). Recipient site was prepared by either cryoblebbing (24 cases) or carbon dioxide (CO2)laser resurfacing (16 cases). Cell counts and viability were recorded in the cell suspensions, and tissue melanocytes and keratinocytes were examined by Melan A and Cytokeratin respectively. Assessment of repigmentation was done 18 months after the procedure.
- Conditions
- Vitiligo
- Being tested
- Melanocyte-keratinocyte suspension
- Keywords
- : non-segmental vitiligo, melanocyte-keratinocyte suspension, cryoblebbing, CO2 laser
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanocyte-keratinocyte suspensionProcedure or surgery
Also called CO2 laser
Treatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension.
| Study group | Role | What they receive |
|---|---|---|
| ORSHFS | Experimental | Melanocyte-keratinocyte suspension. Receives: Procedure: Melanocyte-keratinocyte suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with satisfactory response after the surgical procedure for vitiligo.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completionJun 2014
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 Cairo 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Abdel Halim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510651
- Sponsor's protocol ID
- DAH555
- Status last verified
- Jul 2015
- First submitted
- 22 Jul 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Procedural-Related Variables on Melanocyte-Keratinocyte Suspension Transplantation in Non-Segmental Stable Vitiligo: A Clinical and Immunohistochemical Study
- ClinicalTrials.gov ID
- NCT02510651
- Acronym / sponsor ID
- DAH555
- Conditions
- Vitiligo
- Keywords
- : non-segmental vitiligo, melanocyte-keratinocyte suspension, cryoblebbing, CO2 laser
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Jul 2015 (estimated)
- 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.
ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant repigmentation did not show significant difference with better healing of the donor site. Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better results using combination of donor NCECS and recipient cryoblebs.
Detailed description
Background: Melanocyte-keratinocyte suspension (M-K susp) is gaining popularity for vitiligo treatment. Few studies have addressed procedure-related variables.
Objective: To assess the effect of different M-K susp procedure-related variables on the clinical outcome in stable vitiligo.
Methods: This retrospective study included 40 cases with stable non-segmental vitiligo treated by M-K susp followed by narrow band- ultraviolet B phototherapy twice weekly. Donor site was either a skin graft in non-cultured epidermal cell suspension (NCECS) (34 cases) or hair follicle unit in Outer Root Sheath Hair Follicle Suspension (ORSHFS) (6 cases). Recipient site was prepared by either cryoblebbing (24 cases) or carbon dioxide (CO2)laser resurfacing (16 cases). Cell counts and viability were recorded in the cell suspensions, and tissue melanocytes and keratinocytes were examined by Melan A and Cytokeratin respectively. Assessment of repigmentation was done 18 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ORSHFS | Experimental | Procedure: Melanocyte-keratinocyte suspensionMelanocyte-keratinocyte suspension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stable non-segmental vitiligo
Key exclusion criteria (1 listed)
- Active vitiligo
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 |
|---|---|---|
| Melanocyte-keratinocyte suspensionAlso: CO2 laserTreatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension. | Procedure or surgery | ORSHFS |
Primary outcome
The number of patients with satisfactory response after the surgical procedure for vitiligo.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Melanocyte-keratinocyte suspension in people with Vitiligo, run by Cairo University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with satisfactory response after the surgical procedure for vitiligo. (time frame: one year). 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 29 Jul 2015.