Yale University
New Haven, Connecticut, 06519, United States
NCT Number: NCT04342091
To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia.
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Notify Me18 year and older
Female
Interventional
Not applicable
New Haven, Connecticut, 06519, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Time frame: 6 months
Total number of hairs over an area of 1cm^2
Time frame: 6 months
Total number of hairs over an area of 1 cm^2
Time frame: 6 months
Hair shaft diameter measured per trichoscopy
Time frame: 6 months
Hair shaft diameter measured per trichoscopy
Time frame: 6 months
Number of hair follicles counted per 1cm^2
Time frame: 6 months
Number of hair follicles per 1 cm^2
Time frame: 6 months
Number of vellus hairs per cm^2
Time frame: 6 months
Number of vellus hairs per cm^2
Time frame: 6 months
Number of terminal hairs over an area of 1 cm^2
Time frame: 6 months
Number of terminal hairs per area of 1 cm^2
Yale University
Other
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