Vitiligo
Conditions
Brief 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 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.
Interventions
DEVICEDermabrasion-Micrografting
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).
PROCEDUREDermabrasion
Only dermabrasion (removal of epidermis) alone will be done at baseline.
Sponsors
Momelan Technologies
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Target VASI Score From Baseline to Week 24. | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Effects, Including Increased Activity of Vitiligo | 24 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Dermabrasion-Micrografting, Dermabrasion and Control
Dermabrasion-Micrografting: 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).
Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline.
Control: Untreated depigmented area | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 47 years |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 3 | 2 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dermabrasion-Micrografting | Change in Target VASI Score From Baseline to Week 24. | 0.33 units on a scale |
| Dermabrasion Alone | Change in Target VASI Score From Baseline to Week 24. | 0.33 units on a scale |
| Control | Change in Target VASI Score From Baseline to Week 24. | 0 units on a scale |
Secondary
Incidence of Adverse Effects, Including Increased Activity of Vitiligo
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermabrasion-Micrografting | Incidence of Adverse Effects, Including Increased Activity of Vitiligo | 2 participants reporting redness |
| Dermabrasion Alone | Incidence of Adverse Effects, Including Increased Activity of Vitiligo | 2 participants reporting redness |
| Control | Incidence of Adverse Effects, Including Increased Activity of Vitiligo | 0 participants reporting redness |