Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling

Alopecia Areata Clinical Trial

Official title:

Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04338295
• Other study ID #: 2000027352
• Status: Completed
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: May 16, 2022

Study information

• Verified date: December 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of AA

• SALT score =90%

• No or minimal scalp hair regrowth after =three months of oral JAK inhibitor plus oral minoxidil treatment

Exclusion Criteria:

• Known concomitant androgenetic or other form of alopecia (in addition to AA)

• Patients with the following who would make poor candidates for microneedling such as skin conditions, diabetes, or history of keloid formation

• Anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Device:
• Tattoo machine (SOL Nova Device)
A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target area hair count (TAHC)	Total number of hairs in the area that undergoes microneedling	6 months
Secondary	Hair phase	Number of catagen, anagen hairs	6 months
Secondary	Vellus hairs	Number of vellus hairs in an area of 1cm^2	6 months
Secondary	Terminal hairs	Number of terminal hairs in an area of 1cm^2	6 months