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To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia.
The investigators propose an open label trial of tattoo machine microneedling in ten patients with fibrosing alopecia (five patients with CCCA and five with FFA). Ten healthy female patients older than 18 years will undergo 6 microneedling sessions. Over the course of six months, subjects will undergo up to six treatment sessions (one session every 30 day). Photographs will be taken at each session. Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes. Each visit will last about an hour. Approximately 30 minutes will be spent on consenting and time for patient to ask questions during the first visit. The remaining 30 minutes will be allotted for the investigator to determine if the patient meets criteria for trial enrollment. During the remaining visits, 20 minutes will be allotted for photography, 15-20 minutes for the procedure and 10-15 minutes for post-procedure patient assessment. Remaining 10 minutes on visits 2 and 8 will be used for biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microneedling | Experimental | Participants with fibrosing alopecia will receive microneedling with a tattoo machine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOL Nova Device | Device | A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Area Hair Count (Frontal) | Total number of hairs over an area of 1cm^2 | 6 months |
| Total Area Hair Count (Vertex) | Total number of hairs over an area of 1 cm^2 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hair Shaft Diameters (Frontal) | Hair shaft diameter measured per trichoscopy | 6 months |
| Hair Shaft Diameters (Vertex) | Hair shaft diameter measured per trichoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett King, MD, PhD | Associate Professor of Dermatology, Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06519 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Microneedling | Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Microneedling | Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth. |
| 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 | Total Area Hair Count (Frontal) | Total number of hairs over an area of 1cm^2 | Posted | Mean | Standard Deviation | Count per cm^2 | 6 months |
|
|
6 months
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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 | Microneedling | Participants with fibrosing alopecia will receive microneedling with a tattoo machine. SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tongue Lesion (R Lateral Tongue) | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett King | Yale University | (203) 785-7421 | Brett.King@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2021 | Mar 21, 2023 | Prot_SAP_000.pdf |
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| 6 months |
| Number of Hair Follicles (Frontal) | Number of hair follicles counted per 1cm^2 | 6 months |
| Number of Hair Follicles (Vertex) | Number of hair follicles per 1 cm^2 | 6 months |
| Vellus Hairs (Frontal) | Number of vellus hairs per cm^2 | 6 months |
| Vellus Hairs (Vertex) | Number of vellus hairs per cm^2 | 6 months |
| Terminal Hairs (Frontal) | Number of terminal hairs over an area of 1 cm^2 | 6 months |
| Terminal Hairs (Vertex) | Number of terminal hairs per area of 1 cm^2 | 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total area hair count (frontal) | 4 participants with frontal area analyzed (area of involvement) | Mean | Standard Deviation | Count per cm^2 |
|
| Total hair count (vertex) | 2 participants with vertex area analyzed (area of involvement) | Mean | Standard Deviation | Count per cm^2 |
|
| Hair shaft diameter (frontal) | 4 participants with frontal area analyzed (area of involvement) | Mean | Standard Deviation | micrometer |
|
| Hair shaft diameter (vertex) | 2 participants with vertex area analyzed (area of involvement) | Mean | Standard Deviation | micrometer |
|
| Number of hair follicles (frontal) | 4 participants with frontal area analyzed (area of involvement) | Mean | Standard Deviation | follicle count per cm^2 |
|
| Number of hair follicles (vertex) | 2 participants with vertex area analyzed (area of involvement) | Mean | Standard Deviation | follicle count per cm^2 |
|
| Vellus hairs (frontal) | 4 participants with frontal area analyzed (area of involvement) | Mean | Standard Deviation | Count per cm^2 |
|
| Vellus hairs (vertex) | 2 participants with vertex area analyzed (area of involvement) | Mean | Standard Deviation | Count per cm^2 |
|
| Terminal hairs (frontal) | 4 participants with frontal area analyzed (area of involvement) | Mean | Standard Deviation | Count per cm^2 |
|
| Terminal hairs (vertex) | 2 participants with vertex area analyzed (area of involvement) | Mean | Standard Deviation | Count per cm^2 |
|
|
| Primary | Total Area Hair Count (Vertex) | Total number of hairs over an area of 1 cm^2 | Posted | Mean | Standard Deviation | Count per cm^2 | 6 months |
|
|
|
| Secondary | Hair Shaft Diameters (Frontal) | Hair shaft diameter measured per trichoscopy | Posted | Mean | Standard Deviation | micrometer | 6 months |
|
|
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| Secondary | Hair Shaft Diameters (Vertex) | Hair shaft diameter measured per trichoscopy | Posted | Mean | Standard Deviation | micrometer | 6 months |
|
|
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| Secondary | Number of Hair Follicles (Frontal) | Number of hair follicles counted per 1cm^2 | Posted | Mean | Standard Deviation | Count per cm^2 | 6 months |
|
|
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| Secondary | Number of Hair Follicles (Vertex) | Number of hair follicles per 1 cm^2 | Posted | Mean | Standard Deviation | Count per cm^2 | 6 months |
|
|
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| Secondary | Vellus Hairs (Frontal) | Number of vellus hairs per cm^2 | Posted | Mean | Standard Deviation | Count per cm^2 | 6 months |
|
|
|
| Secondary | Vellus Hairs (Vertex) | Number of vellus hairs per cm^2 | Posted | Mean | Standard Deviation | Count per cm^2 | 6 months |
|
|
|
| Secondary | Terminal Hairs (Frontal) | Number of terminal hairs over an area of 1 cm^2 | Posted | Mean | Standard Deviation | Count per cm^2 | 6 months |
|
|
|
| Secondary | Terminal Hairs (Vertex) | Number of terminal hairs per area of 1 cm^2 | Posted | Mean | Standard Deviation | Count per cm^2 | 6 months |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| Hair shedding | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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