VitiligoMKTPNCT02038257
Comparative Study Using Dermabrasion vs CO2 Laser & Collagen Dressing vs Vaseline Gauze in MKTP
A study testing MKTP (melanocyte keratinocyte transplant procedure), Collagen Dressing and Vaseline Impregnated Gauze in people with Vitiligo and Depigmented Scars, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to: 1. Compare two different techniques in the melanocyte keratinocyte transplant procedure: Use of carbon dioxide laser versus use of dermabrasion 2. Compare two different dressings in the melanocyte keratinocyte transplant procedure: vaseline impregnated gauze versus collagen dressing Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitiligo, Depigmented Scars, Depigmentation
- What is being tested?
- MKTP (melanocyte keratinocyte transplant procedure), Collagen Dressing and Vaseline Impregnated Gauze
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jul 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Depigmented patches of skin
Who cannot join
- History of Acral Vitiligo
- Unstable Vitiligo, defined as new areas of depigmentation or enlarging areas of depigmentation within the last 6 months
- History of hypertrophic scarring or keloids
- History of koebnerization (new patches of vitiligo at sites of injury or trauma)
Trial locations and contacts
1 site in 1 country.
Tasneem Mohammad, MD contact
Cynthia Nicholson, MD contact
United States1 site, 1 recruiting
- Recruiting
Henry Ford Dermatology
Detroit, Michigan, 48202
Tasneem Mohammad, MD, 313-916-6964
Cynthia Nicholson, MD, 313-916-6964
About this study
Official title: Prospective Open Label Parallel Study Comparing Use of Carbon Dioxide Laser Versus Dermabrasion for Denuding Epithelium and Collagen Dressing Versus Vaseline Impregnated Gauze for the Melanocyte Keratinocyte Transplant Procedure
The purpose of this study is to:
- Compare two different techniques in the melanocyte keratinocyte transplant procedure: Use of carbon dioxide laser versus use of dermabrasion
- Compare two different dressings in the melanocyte keratinocyte transplant procedure: vaseline impregnated gauze versus collagen dressing
Read the detailed description
The melanocyte keratinocyte transplant procedure (MKTP) has been shown to be effective in treating vitiligo and other conditions with depigmented skin. MKTP involves the transplantation of melanocytes and keratinocytes from normal skin onto the depigmented skin in order to repigment the skin.
Both dermabrasion and carbon dioxide lasers have been used effectively in MKTP to denude the epithelium. This study will compare the efficacy of these two techniques.
The study will also compare the efficacy of two different dressings used in MKTP, vaseline impregnated gauze and collagen dressings.
- Conditions
- Vitiligo, Depigmented Scars, Depigmentation
- Being tested
- MKTP (melanocyte keratinocyte transplant procedure), Collagen Dressing, Vaseline Impregnated Gauze, Carbon Dioxide Laser, Dermabrasion
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MKTP (melanocyte keratinocyte transplant procedure)Procedure or surgery
Also called MKTP
Each subject will have the melanocyte keratinocyte transplant procedure on 4 distinct areas using the two different techniques being studied (carbon dioxide laser and dermabrasion) and the two different dressings being studied (vaseline impregnated gauze and collagen dressing).
Collagen DressingDevice
Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
Vaseline Impregnated GauzeDevice
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.
Carbon Dioxide LaserDevice
Also called CO2 laser
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using a carbon dioxide laser.
DermabrasionDevice
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.
| Study group | Role | What they receive |
|---|---|---|
| MKTP with CO2 Laser/Collagen Dressing | Active comparator | Each Subject will have a depigmented patch of skin treated with MKTP using the carbon dioxide laser for de-epithelialization and a collagen dressing for the wound dressing. Receives: Procedure: MKTP (melanocyte keratinocyte transplant procedure); Device: Collagen Dressing; Device: Carbon Dioxide Laser |
| MKTP with CO2 laser/vaseline gauze | Active comparator | Each subject will have a depigmented patch of skin treated with MKTP using the carbon dioxide laser for de-epithelialization and vaseline impregnated gauze as the wound dressing. Receives: Procedure: MKTP (melanocyte keratinocyte transplant procedure); Device: Vaseline Impregnated Gauze; Device: Carbon Dioxide Laser |
| MKTP with dermabrasion/collagen dressing | Active comparator | Each subject will have a depigmented patch of skin treated with MKTP using dermabrasion for de-epithelialization and a collagen dressing for the wound dressing. Receives: Procedure: MKTP (melanocyte keratinocyte transplant procedure); Device: Collagen Dressing; Device: Dermabrasion |
| MKTP with dermabrasion/vaseline gauze | Active comparator | Each subject will have a depigmented patch of skin treated with MKTP using dermabrasion for de-epithelialization and vaseline impregnated gauze as a wound dressing. Receives: Procedure: MKTP (melanocyte keratinocyte transplant procedure); Device: Vaseline Impregnated Gauze; Device: Dermabrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitiligo Assessment Scoring Index (VASI)
Assessment of the percentage of repigmentation and color match of the repigmentation.
Measured: 6 months
Secondary outcomes (2)
Time to De-Epithelialization
Amount of time needed to de-epithelialize the skin using carbon dioxide laser versus dermabrasion
Measured: Assessed at Visit 1 (Day of Procedure)
Pain Severity Scale
Assess pain experienced on a severity scale from 0-10 during de-epithelialization with carbon dioxide laser versus dermabrasion, and during dressing application with vaseline impregnated gauze versus collagen dressing.
Measured: Assessed on Visit 1 (Day of Procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2018 (estimated)
- Study completionJul 2019 (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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
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
- NCT02038257
- Sponsor's protocol ID
- 8082
- Acronym
- MKTP
- Status last verified
- Feb 2017
- First submitted
- 10 Jan 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open Label Parallel Study Comparing Use of Carbon Dioxide Laser Versus Dermabrasion for Denuding Epithelium and Collagen Dressing Versus Vaseline Impregnated Gauze for the Melanocyte Keratinocyte Transplant Procedure
- ClinicalTrials.gov ID
- NCT02038257
- Acronym / sponsor ID
- MKTP / 8082
- Conditions
- Vitiligo, Depigmented Scars, Depigmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 16 Jan 2014 (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.
The purpose of this study is to:
- Compare two different techniques in the melanocyte keratinocyte transplant procedure: Use of carbon dioxide laser versus use of dermabrasion
- Compare two different dressings in the melanocyte keratinocyte transplant procedure: vaseline impregnated gauze versus collagen dressing
Detailed description
The melanocyte keratinocyte transplant procedure (MKTP) has been shown to be effective in treating vitiligo and other conditions with depigmented skin. MKTP involves the transplantation of melanocytes and keratinocytes from normal skin onto the depigmented skin in order to repigment the skin.
Both dermabrasion and carbon dioxide lasers have been used effectively in MKTP to denude the epithelium. This study will compare the efficacy of these two techniques.
The study will also compare the efficacy of two different dressings used in MKTP, vaseline impregnated gauze and collagen dressings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MKTP with CO2 Laser/Collagen Dressing | Active comparator | Procedure: MKTP (melanocyte keratinocyte transplant procedure), Device: Collagen Dressing, Device: Carbon Dioxide LaserEach Subject will have a depigmented patch of skin treated with MKTP using the carbon dioxide laser for de-epithelialization and a collagen dressing for the wound dressing. |
| MKTP with CO2 laser/vaseline gauze | Active comparator | Procedure: MKTP (melanocyte keratinocyte transplant procedure), Device: Vaseline Impregnated Gauze, Device: Carbon Dioxide LaserEach subject will have a depigmented patch of skin treated with MKTP using the carbon dioxide laser for de-epithelialization and vaseline impregnated gauze as the wound dressing. |
| MKTP with dermabrasion/collagen dressing | Active comparator | Procedure: MKTP (melanocyte keratinocyte transplant procedure), Device: Collagen Dressing, Device: DermabrasionEach subject will have a depigmented patch of skin treated with MKTP using dermabrasion for de-epithelialization and a collagen dressing for the wound dressing. |
| MKTP with dermabrasion/vaseline gauze | Active comparator | Procedure: MKTP (melanocyte keratinocyte transplant procedure), Device: Vaseline Impregnated Gauze, Device: DermabrasionEach subject will have a depigmented patch of skin treated with MKTP using dermabrasion for de-epithelialization and vaseline impregnated gauze as a wound dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Depigmented patches of skin
Key exclusion criteria (4 listed)
- History of Acral Vitiligo
- Unstable Vitiligo, defined as new areas of depigmentation or enlarging areas of depigmentation within the last 6 months
- History of hypertrophic scarring or keloids
- History of koebnerization (new patches of vitiligo at sites of injury or trauma)
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 |
|---|---|---|
| MKTP (melanocyte keratinocyte transplant procedure)Also: MKTPEach subject will have the melanocyte keratinocyte transplant procedure on 4 distinct areas using the two different techniques being studied (carbon dioxide laser and dermabrasion) and the two different dressings being studied (vaseline impregnated gauze and collagen dressing). | Procedure or surgery | MKTP with CO2 Laser/Collagen Dressing, MKTP with CO2 laser/vaseline gauze, MKTP with dermabrasion/collagen dressing, MKTP with dermabrasion/vaseline gauze |
| Collagen DressingEach subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing. | Device | MKTP with CO2 Laser/Collagen Dressing, MKTP with dermabrasion/collagen dressing |
| Vaseline Impregnated GauzeEach subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze. | Device | MKTP with CO2 laser/vaseline gauze, MKTP with dermabrasion/vaseline gauze |
| Carbon Dioxide LaserAlso: CO2 laserEach subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using a carbon dioxide laser. | Device | MKTP with CO2 Laser/Collagen Dressing, MKTP with CO2 laser/vaseline gauze |
| DermabrasionEach subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion. | Device | MKTP with dermabrasion/collagen dressing, MKTP with dermabrasion/vaseline gauze |
Primary outcome
Vitiligo Assessment Scoring Index (VASI)
Time frame: 6 months
Assessment of the percentage of repigmentation and color match of the repigmentation.
2 secondary outcomes
Time to De-Epithelialization
Time frame: Assessed at Visit 1 (Day of Procedure)
Pain Severity Scale
Time frame: Assessed on Visit 1 (Day of Procedure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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.
Tasneem Mohammad, MD contact
Cynthia Nicholson, MD contact
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 study testing MKTP (melanocyte keratinocyte transplant procedure), Collagen Dressing and Vaseline Impregnated Gauze in people with Vitiligo and Depigmented Scars, 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 1 inclusion and 4 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 Feb 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.
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 Tasneem Mohammad, MD (313-916-6964), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitiligo Assessment Scoring Index (VASI) (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 23 Feb 2017.