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The study sponsor was acquired by a company that focuses on chronic wounds.
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| Name | Class |
|---|---|
| Momelan Technologies | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermabrasion-Micrografting | Experimental | Dermabrasion-Micrografting |
|
| Dermabrasion alone | Active Comparator | Dermabrasion alone |
|
| Control | No Intervention | Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermabrasion-Micrografting | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Effects, Including Increased Activity of Vitiligo | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra B Kimball, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mgh Curtis | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Vitiligo | Three subjects with vitiligo were recruited for the study. All subjects had three test sites that were studied. One site received dermabrasion and micrografting, one site received dermabrasion alone and one site was not treated and served as the control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Full Range | units on a scale | 24 weeks |
|
24 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dermabrasion-Micrografting | Dermabrasion-Micrografting 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
Early termination of study leading to small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexandra Kimball | Massachusetts General Hospital | 617-726-5066 | harvardskinstudies@partners.org |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003869 | Dermabrasion |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D062109 | Dermatologic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
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|
| Dermabrasion | Procedure | Only dermabrasion (removal of epidermis) alone will be done at baseline. |
|
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Dermabrasion alone
Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline.
| OG002 | Control | Target sites did not receive any treatment |
|
|
| Secondary | Incidence of Adverse Effects, Including Increased Activity of Vitiligo | Posted | Number | participants reporting redness | 24 weeks |
|
|
|
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Dermabrasion Alone | Dermabrasion alone Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline. | 0 | 3 | 2 | 3 |
| EG002 | Control | Control Depigmented areas that did not receive any treatment. | 0 | 3 | 0 | 3 |
| Moderate Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D013514 | Surgical Procedures, Operative |