Central Centrifugal Cicatricial Alopecia, Fibrosing Alopecia, Frontal Fibrosing Alopecia
Conditions
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.
Interventions
DEVICESOL Nova Device
A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Area Hair Count (Frontal) | 6 months | Total number of hairs over an area of 1cm\^2 |
| Total Area Hair Count (Vertex) | 6 months | Total number of hairs over an area of 1 cm\^2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hair Follicles (Frontal) | 6 months | Number of hair follicles counted per 1cm\^2 |
| Number of Hair Follicles (Vertex) | 6 months | Number of hair follicles per 1 cm\^2 |
| Vellus Hairs (Frontal) | 6 months | Number of vellus hairs per cm\^2 |
| Hair Shaft Diameters (Frontal) | 6 months | Hair shaft diameter measured per trichoscopy |
| Terminal Hairs (Frontal) | 6 months | Number of terminal hairs over an area of 1 cm\^2 |
| Terminal Hairs (Vertex) | 6 months | Number of terminal hairs per area of 1 cm\^2 |
| Vellus Hairs (Vertex) | 6 months | Number of vellus hairs per cm\^2 |
| Hair Shaft Diameters (Vertex) | 6 months | Hair shaft diameter measured per trichoscopy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Microneedling Participants with fibrosing alopecia will receive microneedling with a tattoo machine.
SOL Nova Device: A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Microneedling |
|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 10.5 |
| Hair shaft diameter (frontal) | 62.3 micrometer STANDARD_DEVIATION 16.5 |
| Hair shaft diameter (vertex) | 72.2 micrometer STANDARD_DEVIATION 7.1 |
| Number of hair follicles (frontal) | 46.0 follicle count per cm^2 STANDARD_DEVIATION 55.8 |
| Number of hair follicles (vertex) | 31.5 follicle count per cm^2 STANDARD_DEVIATION 2.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
| Terminal hairs (frontal) | 49.3 Count per cm^2 STANDARD_DEVIATION 66.8 |
| Terminal hairs (vertex) | 32.5 Count per cm^2 STANDARD_DEVIATION 6.4 |
| Total area hair count (frontal) | 50.0 Count per cm^2 STANDARD_DEVIATION 66.3 |
| Total hair count (vertex) | 32.5 Count per cm^2 STANDARD_DEVIATION 6.4 |
| Vellus hairs (frontal) | 0.8 Count per cm^2 STANDARD_DEVIATION 1.5 |
| Vellus hairs (vertex) | 0 Count per cm^2 STANDARD_DEVIATION 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Total Area Hair Count (Frontal)
Total number of hairs over an area of 1cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Total Area Hair Count (Frontal) | 86.8 Count per cm^2 | Standard Deviation 73 |
Primary
Total Area Hair Count (Vertex)
Total number of hairs over an area of 1 cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Total Area Hair Count (Vertex) | 117.5 Count per cm^2 | Standard Deviation 115.3 |
Secondary
Hair Shaft Diameters (Frontal)
Hair shaft diameter measured per trichoscopy
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Hair Shaft Diameters (Frontal) | 61.1 micrometer | Standard Deviation 19.6 |
Secondary
Hair Shaft Diameters (Vertex)
Hair shaft diameter measured per trichoscopy
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Hair Shaft Diameters (Vertex) | 63.5 micrometer | Standard Deviation 5.2 |
Secondary
Number of Hair Follicles (Frontal)
Number of hair follicles counted per 1cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Number of Hair Follicles (Frontal) | 70.3 Count per cm^2 | Standard Deviation 59.6 |
Secondary
Number of Hair Follicles (Vertex)
Number of hair follicles per 1 cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Number of Hair Follicles (Vertex) | 74.0 Count per cm^2 | Standard Deviation 53.7 |
Secondary
Terminal Hairs (Frontal)
Number of terminal hairs over an area of 1 cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Terminal Hairs (Frontal) | 85.3 Count per cm^2 | Standard Deviation 74.6 |
Secondary
Terminal Hairs (Vertex)
Number of terminal hairs per area of 1 cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Terminal Hairs (Vertex) | 117.5 Count per cm^2 | Standard Deviation 115.3 |
Secondary
Vellus Hairs (Frontal)
Number of vellus hairs per cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Vellus Hairs (Frontal) | 1.5 Count per cm^2 | Standard Deviation 3 |
Secondary
Vellus Hairs (Vertex)
Number of vellus hairs per cm\^2
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microneedling | Vellus Hairs (Vertex) | 0 Count per cm^2 | Standard Deviation 0 |