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The intent of this study is to evaluate the efficacy of microneedling through use of a professional tattoo machine in hair regrowth in patients with androgenic alopecia (AGA) over up to 6 treatments (6 months).
Proposed is an open label trial of tattoo machine microneedling in ten patients with androgenic alopecia. Ten healthy male 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). Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microneedling | Experimental | Participants with androgenic alopecia will receive microneedling with a tattoo machine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tattoo machine | Device | A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Area Hair Count | Total number of hairs in an area of 1 cm^2 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| SALT Score | The Severity of Alopecia Tool measures percentage of scalp hair loss | 6 months |
| Hair Shaft Diameter | The diameter of the hair shaft as measured by 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 androgenic alopecia will receive microneedling with a tattoo machine. Tattoo machine: A SOL Nova Device (brand) 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 androgenic alopecia will receive microneedling with a tattoo machine. Tattoo machine: A SOL Nova Device (brand) 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 | Total number of hairs in an area of 1 cm^2 | Posted | Mean | Standard Deviation | hairs 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 androgenic alopecia will receive microneedling with a tattoo machine. Tattoo machine: A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subdural hematoma | Vascular disorders | Systematic Assessment | Patient slipped on the ice and hit their head (unrelated to study). Patient withdrawn from study. |
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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 | May 5, 2021 | Apr 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 6 months |
| Number of Follicular Units | Number of follicular units with one or more hair follicles over an area of 1cm^2 | 6 months |
| Vellus Hairs | Number of vellus hairs over an area of 1 cm^2 | 6 months |
| Terminal Hairs | Terminal hairs over an area of 1 cm^2 | 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Total area hair count | Mean | Standard Deviation | hairs per cm^2 |
|
| SALT Score | Mean | Standard Deviation | percentage of hair loss |
|
| Hair Shaft Diameters | Mean | Standard Deviation | micrometer |
|
| Number of hair follicles | Mean | Standard Deviation | hair follicles per cm^2 |
|
| Number of Vellus Hairs | Mean | Standard Deviation | vellus hairs per cm^2 |
|
| Number of Terminal Hairs | Mean | Standard Deviation | terminal hairs per cm^2 |
|
|
| Secondary | SALT Score | The Severity of Alopecia Tool measures percentage of scalp hair loss | Posted | Mean | Standard Deviation | percentage of hair loss | 6 months |
|
|
|
| Secondary | Hair Shaft Diameter | The diameter of the hair shaft as measured by trichoscopy | Posted | Mean | Standard Deviation | micrometer | 6 months |
|
|
|
| Secondary | Number of Follicular Units | Number of follicular units with one or more hair follicles over an area of 1cm^2 | Posted | Mean | Standard Deviation | follicular units per cm^2 | 6 months |
|
|
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| Secondary | Vellus Hairs | Number of vellus hairs over an area of 1 cm^2 | Posted | Mean | Standard Deviation | vellus hairs per cm^2 | 6 months |
|
|
|
| Secondary | Terminal Hairs | Terminal hairs over an area of 1 cm^2 | Posted | Mean | Standard Deviation | terminal hairs per cm^2 | 6 months |
|
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| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |