VitiligoPhase 3MKTPNCT00830713
Vitiligo Skin Transplantation
A Phase 3 study testing Melanocyte-keratinocyte transplantation procedure (MKTP) in people with Vitiligo, run by Henry Ford Health System at 1 site in United States.
Trial summary
In vitiligo, the melanocytes are lost from the skin in certain areas. One treatment for vitiligo takes the melanocytes from areas of normal skin and places them on areas of that same person's body which have lost their color. This is called the melanocyte-keratinocyte transplantation procedure (MKTP). 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 transplantation procedure (MKTP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Oct 2011
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years old
- Have a diagnosis of vitiligo with no news lesions or growth of old lesions in the past 6 months
- 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 who are breastfeeding, pregnant, or planning to become pregnant
- Patients with a history of developing vitiligo or keloids 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Medical Center, New Center One
Detroit, Michigan, 48202
About this study
Official title: Safety and Efficacy of Melanocyte-keratinocyte Transplantation in the Treatment of Vitiligo
In vitiligo, the melanocytes are lost from the skin in certain areas. One treatment for vitiligo takes the melanocytes from areas of normal skin and places them on areas of that same person's body which have lost their color. This is called the melanocyte-keratinocyte transplantation procedure (MKTP). This procedure has been used successfully in over 3000 cases in India and Saudi Arabia. The purpose of this study is to see if it is effective when performed at the investigators' institution.
- Conditions
- Vitiligo
- Being tested
- Melanocyte-keratinocyte transplantation procedure (MKTP)
- Keywords
- vitiligo, skin transplantation, non-cultured, melanocyte, surgery
- 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 transplantation procedure (MKTP)Procedure or surgery
skin pigment cells are taken from areas of normal skin and placed on areas of that same person's body which have lost their color.
| Study group | Role | What they receive |
|---|---|---|
| MKTP treatment | Experimental | subject will undergo MKTP Receives: Procedure: Melanocyte-keratinocyte transplantation procedure (MKTP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of MKTP in treating vitiligo
Assessed by percent repigmentation (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%).
Measured: 6 months
Secondary outcomes (1)
safety of MKTP in treating vitiligo
Assessed by frequency of adverse events, including, scarring, infection, etc.
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 posted28 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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 Health Systems Dermatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830713
- Sponsor's protocol ID
- 5385
- Acronym
- MKTP
- Status last verified
- May 2010
- First submitted
- 27 Jan 2009
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mulekar SV. Long-term follow-up study of segmental and focal vitiligo treated by autologous, noncultured melanocyte-keratinocyte cell transplantation. Arch Dermatol. 2004 Oct;140(10):1211-5. doi: 10.1001/archderm.140.10.1211.
PubMed 15492183Mulekar SV. Long-term follow-up study of 142 patients with vitiligo vulgaris treated by autologous, non-cultured melanocyte-keratinocyte cell transplantation. Int J Dermatol. 2005 Oct;44(10):841-5. doi: 10.1111/j.1365-4632.2005.02226.x.
PubMed 16207186
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Melanocyte-keratinocyte Transplantation in the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT00830713
- Acronym / sponsor ID
- MKTP / 5385
- Conditions
- Vitiligo
- Keywords
- vitiligo, skin transplantation, non-cultured, melanocyte, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Jan 2009 (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.
In vitiligo, the melanocytes are lost from the skin in certain areas. One treatment for vitiligo takes the melanocytes from areas of normal skin and places them on areas of that same person's body which have lost their color. This is called the melanocyte-keratinocyte transplantation procedure (MKTP). This procedure has been used successfully in over 3000 cases in India and Saudi Arabia. The purpose of this study is to see if it is effective when performed at the investigators' institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MKTP treatment | Experimental | Procedure: Melanocyte-keratinocyte transplantation procedure (MKTP)subject will undergo MKTP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years old
- Have a diagnosis of vitiligo with no news lesions or growth of old lesions in the past 6 months
- 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 (5 listed)
- Female patients who are breastfeeding, pregnant, or planning to become pregnant
- Patients with a history of developing vitiligo or keloids 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 transplantation procedure (MKTP)skin pigment cells are taken from areas of normal skin and placed on areas of that same person's body which have lost their color. | Procedure or surgery | MKTP treatment |
Primary outcome
effectiveness of MKTP in treating vitiligo
Time frame: 6 months
Assessed by percent repigmentation (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%).
1 secondary outcome
safety of MKTP in treating vitiligo
Time frame: 6 months
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 6 Sep 2012.
- Background: PubMed 15492183Mulekar SV. Long-term follow-up study of segmental and focal vitiligo treated by autologous, noncultured melanocyte-keratinocyte cell transplantation. Arch Dermatol. 2004 Oct;140(10):1211-5. doi: 10.1001/archderm.140.10.1211.
- Background: PubMed 16207186Mulekar SV. Long-term follow-up study of 142 patients with vitiligo vulgaris treated by autologous, non-cultured melanocyte-keratinocyte cell transplantation. Int J Dermatol. 2005 Oct;44(10):841-5. doi: 10.1111/j.1365-4632.2005.02226.x.
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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.
Iltefat H Hamzavi, MD principal investigator
Henry Ford Health Systems Dermatology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melanocyte-keratinocyte transplantation procedure (MKTP) 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 4 inclusion and 5 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 6 Sep 2012. 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 phase mean?
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 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?
effectiveness of MKTP in treating vitiligo (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00830713, which also lists 2 linked publications.
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 6 Sep 2012.