Clinical trial NCT04342091: Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling
Official title: Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibrosing Alopecia
Frontal Fibrosing Alopecia
Central Centrifugal Cicatricial Alopecia
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy Female
* Diagnosing Fibrosing alopecia

Exclusion Criteria:

* Any female with hair loss for other reasons
* Males
* Patients with cardiac conditions or renal insufficiency
* Pregnant patients
* Patients containing the following who would make poor candidates for microneedling, such as skin conditions, diabetes, history of keloid formation
* Anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate

Primary outcomes:
measure: Total Area Hair Count (Frontal)
timeFrame: 6 months
measure: Total Area Hair Count (Vertex)
timeFrame: 6 months
Secondary outcomes:
measure: Hair Shaft Diameters (Frontal)
timeFrame: 6 months
measure: Hair Shaft Diameters (Vertex)
timeFrame: 6 months
measure: Number of Hair Follicles (Frontal)
timeFrame: 6 months
measure: Number of Hair Follicles (Vertex)
timeFrame: 6 months
measure: Vellus Hairs (Frontal)
timeFrame: 6 months
measure: Vellus Hairs (Vertex)
timeFrame: 6 months
measure: Terminal Hairs (Frontal)
timeFrame: 6 months
measure: Terminal Hairs (Vertex)
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Associate Professor of Dermatology, Yale University
name: Brett King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: