Yale University
New Haven, Connecticut, 06519, United States
NCT Number: NCT04338295
The investigators propose to study the efficacy of micro-needling via the SOL Nova Device in generating hair growth in patients with Alopecia Areta (AA) who are either non-responsive or only partially responsive to combination oral JAK inhibitor plus oral minoxidil therapy.
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Notify Me18 year and older
Male
Interventional
Not applicable
New Haven, Connecticut, 06519, United States
This will be a trial evaluating the efficacy of micro-needling via tattoo device in stimulating scalp hair growth in patients with AA refractory to combination JAK inhibitor and oral minoxidil treatment. Ten healthy subjects who are at least eighteen years of age who have experienced no or partial scalp hair regrowth after ≥three months of JAK inhibitor plus oral minoxidil treatment will be enrolled. Subjects will undergo a treatment session once every thirty days for a total of six sessions over six months and will complete a total of eight visits over eight months. Procedures and visits are not standard of care but conducted for research. 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) tattoo machine will be used to stimulate hair regrowth.
Time frame: 6 months
Total number of hairs in the area that undergoes microneedling
Time frame: 6 months
Number of catagen, anagen hairs
Time frame: 6 months
Number of vellus hairs in an area of 1cm^2
Time frame: 6 months
Number of terminal hairs in an area of 1cm^2
Yale University
Other
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