VitiligoPhase 2NCT01262547
A New Micrografting Technique for Vitiligo
A Phase 2 study testing Dermabrasion-Micrografting and Dermabrasion in people with Vitiligo, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study evaluates micrografting using a harvesting and grafting process that has been designed by Momelan Technologies. The overall concept is to harvest several small pieces of skin, each measuring about 1.75 mm in diameter from a normal pigmented area using a commercially available suction blister device, adhere… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Dermabrasion-Micrografting and Dermabrasion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 to 80 years old
- Have a diagnosis of stable vitiligo as defined by Vitiligo Disease Activity Score of 0 or 1
- Has 3 comparable vitiliginous areas of trunk or extremities (excluding hands) each measuring at least 3cm×3cm in size, with at least 80% of depigmentation, and anticipated equal sun exposure.
- Have not used any topical therapy to patches or Ultraviolet light therapy for at least 2 weeks (subjects may restart phototherapy at week 10 if desired)
- 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 hypertrophic scaring or keloids and psoriasis
- Subjects on any dose of coumadin, warfarin, Plavix or at least 325 mg aspirin.
- Concurrent use of immunosuppressive medications such as oral steroids, tacrolimus and other cytotoxic reagents within 2 weeks of grafting)
- Subject who received topical therapy or UV light ( phototherapy)in last 2 weeks
- Patients with a positive HIV status
Show all 9Show fewer
- Patients withDiabetes Mellitus with a hemoglobin A1C of more than 8.
- Subjects with dermatologic conditions that may Koebnerize such as psoriasis and lichen planus.
- Participation in another interventional study with potential exposure to an investigational drug within past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Pilot Study to Examine the Use of Micrografting, Using a Novel Grafting Technique for the Repigmentation of Vitiligo
This study evaluates micrografting using a harvesting and grafting process that has been designed by Momelan Technologies. The overall concept is to harvest several small pieces of skin, each measuring about 1.75 mm in diameter from a normal pigmented area using a commercially available suction blister device, adhere them to a sterile elastomeric substrate and is then place it on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).
Read the detailed description
Participants with vitiligo patches undergo removal of the epidermis of the affected vitiligo skin with dermabrasion. Several small pieces of pigmented skin (1.75mm) from the patient are taken from another area with the use of a suction blister device. The harvested pigmented skin is adhered to a sterile elastomeric substrate and placed on the previously dermabraded affected area.
Originally the primary outcome was percentage of change in pigmentation with UV photos at 10 weeks in sites undergoing grafts compared to control sites. However, because we were unable to take UV photos, we had to revise our primary outcome.
- Conditions
- Vitiligo
- Being tested
- Dermabrasion-Micrografting, Dermabrasion
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermabrasion-MicrograftingDevice
Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).
DermabrasionProcedure or surgery
Only dermabrasion (removal of epidermis) alone will be done at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Dermabrasion-Micrografting | Experimental | Dermabrasion-Micrografting Receives: Device: Dermabrasion-Micrografting |
| Dermabrasion alone | Active comparator | Dermabrasion alone Receives: Procedure: Dermabrasion |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Target VASI Score From Baseline to Week 24.
Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).
Measured: 24 weeks
Secondary outcomes (1)
Incidence of Adverse Effects, Including Increased Activity of Vitiligo
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: The study sponsor was acquired by a company that focuses on chronic wounds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Momelan Technologies
- Responsible party
- Principal investigator, Alexandra Kimball, Massachusetts General Hospital
- Investigators
- Alexandra B Kimball, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262547
- Sponsor's protocol ID
- 2010-p-001784
- Status last verified
- Oct 2014
- First submitted
- 16 Dec 2010
- Last updated
- 31 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Study to Examine the Use of Micrografting, Using a Novel Grafting Technique for the Repigmentation of Vitiligo
- ClinicalTrials.gov ID
- NCT01262547
- Acronym / sponsor ID
- 2010-p-001784
- Conditions
- Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study sponsor was acquired by a company that focuses on chronic wounds.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Momelan Technologies
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Posted 31 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates micrografting using a harvesting and grafting process that has been designed by Momelan Technologies. The overall concept is to harvest several small pieces of skin, each measuring about 1.75 mm in diameter from a normal pigmented area using a commercially available suction blister device, adhere them to a sterile elastomeric substrate and is then place it on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).
Detailed description
Participants with vitiligo patches undergo removal of the epidermis of the affected vitiligo skin with dermabrasion. Several small pieces of pigmented skin (1.75mm) from the patient are taken from another area with the use of a suction blister device. The harvested pigmented skin is adhered to a sterile elastomeric substrate and placed on the previously dermabraded affected area.
Originally the primary outcome was percentage of change in pigmentation with UV photos at 10 weeks in sites undergoing grafts compared to control sites. However, because we were unable to take UV photos, we had to revise our primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dermabrasion-Micrografting | Experimental | Device: Dermabrasion-MicrograftingDermabrasion-Micrografting |
| Dermabrasion alone | Active comparator | Procedure: DermabrasionDermabrasion alone |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 to 80 years old
- Have a diagnosis of stable vitiligo as defined by Vitiligo Disease Activity Score of 0 or 1
- Has 3 comparable vitiliginous areas of trunk or extremities (excluding hands) each measuring at least 3cm×3cm in size, with at least 80% of depigmentation, and anticipated equal sun exposure.
- Have not used any topical therapy to patches or Ultraviolet light therapy for at least 2 weeks (subjects may restart phototherapy at week 10 if desired)
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
Key exclusion criteria (9 listed)
- Female patients who are breastfeeding, pregnant, or planning to become pregnant
- Patients with a history of hypertrophic scaring or keloids and psoriasis
- Subjects on any dose of coumadin, warfarin, Plavix or at least 325 mg aspirin.
- Concurrent use of immunosuppressive medications such as oral steroids, tacrolimus and other cytotoxic reagents within 2 weeks of grafting)
- Subject who received topical therapy or UV light ( phototherapy)in last 2 weeks
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 |
|---|---|---|
| Dermabrasion-MicrograftingSeveral small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis). | Device | Dermabrasion-Micrografting |
| DermabrasionOnly dermabrasion (removal of epidermis) alone will be done at baseline. | Procedure or surgery | Dermabrasion alone |
Primary outcome
Change in Target VASI Score From Baseline to Week 24.
Time frame: 24 weeks
Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).
1 secondary outcome
Incidence of Adverse Effects, Including Increased Activity of Vitiligo
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alexandra B Kimball, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dermabrasion-Micrografting and Dermabrasion in people with Vitiligo, run by Massachusetts General Hospital 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 31 Oct 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Target VASI Score From Baseline to Week 24. (time frame: 24 weeks). 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 31 Oct 2014.