A Phase 2 interventional study of Dermabrasion-Micrografting and Dermabrasion in Vitiligo, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-10-31.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
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).
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.
298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.
This study's enrollment of 3 is below the median of 30 across 227 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Massachusetts General Hospital is the lead sponsor of 2,537 studies on the registry; 447 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dermabrasion-Micrografting
Device: Dermabrasion-Micrografting
Dermabrasion alone
Procedure: Dermabrasion
Control
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).
Only dermabrasion (removal of epidermis) alone will be done at baseline.
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).
Time frame: 24 weeks
Incidence of Adverse Effects, Including Increased Activity of Vitiligo
Time frame: 24 weeks
| Milestone | Patients With Vitiligo |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).
| units on a scale | Dermabrasion-Micrografting | Dermabrasion Alone | Control |
|---|---|---|---|
| Change in Target VASI Score From Baseline to Week 24. | 0.33 (0 to 1) | 0.33 (0 to 1) | 0 (0 to 0) |
| participants reporting redness | Dermabrasion-Micrografting | Dermabrasion Alone | Control |
|---|---|---|---|
| Incidence of Adverse Effects, Including Increased Activity of Vitiligo | 2 | 2 | 0 |
Collected over 24 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dermabrasion-Micrografting | — | 0/3 (0%) | 2/3 (66.7%) |
| Dermabrasion Alone | — | 0/3 (0%) | 2/3 (66.7%) |
| Control | — | 0/3 (0%) | 0/3 (0%) |
| Event | Dermabrasion-Micrografting | Dermabrasion Alone | Control |
|---|---|---|---|
| Mild RednessSkin and subcutaneous tissue disorders | 1/3 | 1/3 | 0/3 |
| Moderate RednessSkin and subcutaneous tissue disorders | 1/3 | 1/3 | 0/3 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 47 (43 to 53) |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 1 |
| Male | 2 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 3 |
This study is terminated, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital