VitiligoPhase 2/3NCT01822379
Comparative Study of Techniques in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo
A Phase 2/3 study testing Melanocyte Keratinocyte transplantation in people with Vitiligo, run by Henry Ford Health System at 1 site in United States.
Trial summary
Previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin cells (keratinocytes) for the treatment of vitiligo. This procedure is known as MKTP (Melanocyte Keratinocyte Transplantation Procedure). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Melanocyte Keratinocyte transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jul 2012
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years old
- Have a diagnosis of generalized vitiligo-vitiligo affecting both sides of the body on one or more areas of the body (extremities, trunk, etc.)
- Have stable vitiligo, defined as no new lesion development (or expansion of existing lesions) in the 6 months prior to proposed procedure date
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- Agree to follow and undergo all study-related procedures
Who cannot join
- Female patients self-reported to be lactating, pregnant, or planning to become pregnant
- Patients with a history of developing vitiligo or hypertrophic scars at sites of trauma
- Patients self-reported as having HIV or Hepatitis C
- Patients self-reported as having uncontrolled Diabetes Mellitus
- The investigator feels the patient should not participate in the study for any reason
- Patients with acral vitiligo, defined as significant involvement of the fingers and/or toes
- Patients with focal or segmental vitiligo, defined as vitiligo affecting only one area of the body on only one side of the body
- Patients with vitiligo affecting greater than 30% of their body surface area
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Hospital Department of Dermatology
Detroit, Michigan, 48202
About this study
Official title: Comparative Study of the Use of Trypsin Versus Dispase in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo
Previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin cells (keratinocytes) for the treatment of vitiligo. This procedure is known as MKTP (Melanocyte Keratinocyte Transplantation Procedure). Multiple studies have found this procedure to be both safe and effective for the treatment of vitiligo. The majority of these studies utilized trypsin to help isolate melanocytes and keratinocytes. Trypsin is enzyme that helps to separate the different layers of skin. However, some cell biologists believe that the enzyme dispase (which can be used to separate the epidermis from the dermis) is less toxic to cells of the epidermis and can result in a greater number of viable melanocytes and keratinocytes for transplantation.
This study will look at the repigmentation rates of MKTP using trypsin to isolate cells, versus MKTP using dispase to isolate cells.
- Conditions
- Vitiligo
- Being tested
- Melanocyte Keratinocyte transplantation
- 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 transplantationProcedure or surgery
Transplantation of cells prepared with dispase
| Study group | Role | What they receive |
|---|---|---|
| Cell transplantation | Experimental | All patients will undergo transplantation of two distinct vitiligo lesions. One lesion will receive cells prepared with trypsin. The other lesion will receive cells prepared with dispase. Receives: Procedure: Melanocyte Keratinocyte transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigmentation
Investigator will assess amount of pigmentation at site of procedure.
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 posted2 Apr 2013 (estimated)
- Study startMay 2010
- Primary completionJul 2011
- Study completionJul 2012
Why it stopped: This study was never initiated.
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 Henry Ford Health SystemThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- diaspase versus trypsin for cell separation
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat H Hamzavi, MD, Principal investigator, Henry Ford Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822379
- Sponsor's protocol ID
- IRB #6121
- Status last verified
- Mar 2017
- First submitted
- 12 May 2010
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Use of Trypsin Versus Dispase in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT01822379
- Acronym / sponsor ID
- IRB #6121
- Conditions
- Vitiligo
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Apr 2013 (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.
Previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin cells (keratinocytes) for the treatment of vitiligo. This procedure is known as MKTP (Melanocyte Keratinocyte Transplantation Procedure). Multiple studies have found this procedure to be both safe and effective for the treatment of vitiligo. The majority of these studies utilized trypsin to help isolate melanocytes and keratinocytes. Trypsin is enzyme that helps to separate the different layers of skin. However, some cell biologists believe that the enzyme dispase (which can be used to separate the epidermis from the dermis) is less toxic to cells of the epidermis and can result in a greater number of viable melanocytes and keratinocytes for transplantation.
This study will look at the repigmentation rates of MKTP using trypsin to isolate cells, versus MKTP using dispase to isolate cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
- Model description
- diaspase versus trypsin for cell separation
| Arm | Type | Receives |
|---|---|---|
| Cell transplantation | Experimental | Procedure: Melanocyte Keratinocyte transplantationAll patients will undergo transplantation of two distinct vitiligo lesions. One lesion will receive cells prepared with trypsin. The other lesion will receive cells prepared with dispase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be at least 18 years old
- Have a diagnosis of generalized vitiligo-vitiligo affecting both sides of the body on one or more areas of the body (extremities, trunk, etc.)
- Have stable vitiligo, defined as no new lesion development (or expansion of existing lesions) in the 6 months prior to proposed procedure date
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- Agree to follow and undergo all study-related procedures
Key exclusion criteria (8 listed)
- Female patients self-reported to be lactating, pregnant, or planning to become pregnant
- Patients with a history of developing vitiligo or hypertrophic scars at sites of trauma
- Patients self-reported as having HIV or Hepatitis C
- Patients self-reported as having uncontrolled Diabetes Mellitus
- The investigator feels the patient should not participate in the study for any reason
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 transplantationTransplantation of cells prepared with dispase | Procedure or surgery | Cell transplantation |
Primary outcome
Pigmentation
Time frame: 6 months
Investigator will assess amount of pigmentation at site of procedure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Related trials for Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo
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.
Iltefat H Hamzavi, MD principal investigator
Henry Ford Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melanocyte Keratinocyte transplantation in people with Vitiligo, run by Henry Ford Health System at 1 site in United States.
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 8 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: withdrawn, as of the sponsor's last update on 10 Mar 2017. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pigmentation (time frame: 6 months). 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 10 Mar 2017.