An interventional study of SOL Nova Device in Fibrosing Alopecia, Frontal Fibrosing Alopecia and Central Centrifugal Cicatricial Alopecia, sponsored by Yale University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's enrollment of 6 is below the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with fibrosing alopecia will receive microneedling with a tattoo machine.
Device: SOL Nova Device
A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Total Area Hair Count (Frontal)
Total number of hairs over an area of 1cm\^2
Time frame: 6 months
Total Area Hair Count (Vertex)
Total number of hairs over an area of 1 cm\^2
Time frame: 6 months
Hair Shaft Diameters (Frontal)
Hair shaft diameter measured per trichoscopy
Time frame: 6 months
Hair Shaft Diameters (Vertex)
Hair shaft diameter measured per trichoscopy
Time frame: 6 months
Number of Hair Follicles (Frontal)
Number of hair follicles counted per 1cm\^2
Time frame: 6 months
Number of Hair Follicles (Vertex)
Number of hair follicles per 1 cm\^2
Time frame: 6 months
Vellus Hairs (Frontal)
Number of vellus hairs per cm\^2
Time frame: 6 months
Vellus Hairs (Vertex)
Number of vellus hairs per cm\^2
Time frame: 6 months
Terminal Hairs (Frontal)
Number of terminal hairs over an area of 1 cm\^2
Time frame: 6 months
Terminal Hairs (Vertex)
Number of terminal hairs per area of 1 cm\^2
Time frame: 6 months
| Milestone | Microneedling |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
Total number of hairs over an area of 1cm\^2
| Count per cm^2 | Microneedling |
|---|---|
| Total Area Hair Count (Frontal) | 86.8 ± 73.0 |
Total number of hairs over an area of 1 cm\^2
| Count per cm^2 | Microneedling |
|---|---|
| Total Area Hair Count (Vertex) | 117.5 ± 115.3 |
Hair shaft diameter measured per trichoscopy
| micrometer | Microneedling |
|---|---|
| Hair Shaft Diameters (Frontal) | 61.1 ± 19.6 |
Hair shaft diameter measured per trichoscopy
| micrometer | Microneedling |
|---|---|
| Hair Shaft Diameters (Vertex) | 63.5 ± 5.2 |
Number of hair follicles counted per 1cm\^2
| Count per cm^2 | Microneedling |
|---|---|
| Number of Hair Follicles (Frontal) | 70.3 ± 59.6 |
Number of hair follicles per 1 cm\^2
| Count per cm^2 | Microneedling |
|---|---|
| Number of Hair Follicles (Vertex) | 74.0 ± 53.7 |
Number of vellus hairs per cm\^2
| Count per cm^2 | Microneedling |
|---|---|
| Vellus Hairs (Frontal) | 1.5 ± 3.0 |
Number of vellus hairs per cm\^2
| Count per cm^2 | Microneedling |
|---|---|
| Vellus Hairs (Vertex) | 0 ± 0 |
Number of terminal hairs over an area of 1 cm\^2
| Count per cm^2 | Microneedling |
|---|---|
| Terminal Hairs (Frontal) | 85.3 ± 74.6 |
Number of terminal hairs per area of 1 cm\^2
| Count per cm^2 | Microneedling |
|---|---|
| Terminal Hairs (Vertex) | 117.5 ± 115.3 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Microneedling | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Event | Microneedling |
|---|---|
| Tongue Lesion (R Lateral Tongue)Gastrointestinal disorders | 1/6 |
| Hair sheddingSkin and subcutaneous tissue disorders | 1/6 |
| Age, Continuous(years) | Microneedling |
|---|---|
| Mean | 58.8 ± 10.5 |
| Sex: Female, Male(Participants) | Microneedling |
|---|---|
| Female | 6 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Microneedling |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Total area hair count (frontal)(Count per cm^2) | Microneedling |
|---|---|
| Mean | 50.0 ± 66.3 |
| Total hair count (vertex)(Count per cm^2) | Microneedling |
|---|---|
| Mean | 32.5 ± 6.4 |
| Hair shaft diameter (frontal)(micrometer) | Microneedling |
|---|---|
| Mean | 62.3 ± 16.5 |
| Hair shaft diameter (vertex)(micrometer) | Microneedling |
|---|---|
| Mean | 72.2 ± 7.1 |
| Number of hair follicles (frontal)(follicle count per cm^2) | Microneedling |
|---|---|
| Mean | 46.0 ± 55.8 |
5 further baseline measures are reported on the registry.
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Yale University