N/A
N=6
Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling
Fibrosing Alopecia · Frontal Fibrosing Alopecia · Central Centrifugal Cicatricial Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT04342091 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Total Area Hair Count (Frontal) — 86.8 Count per cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SOL Nova Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Area Hair Count (Frontal) |
86.8 | — |
| PRIMARY Total Area Hair Count (Vertex) |
117.5 | — |
| SECONDARY Hair Shaft Diameters (Frontal) |
61.1 | — |
| SECONDARY Hair Shaft Diameters (Vertex) |
63.5 | — |
| SECONDARY Number of Hair Follicles (Frontal) |
70.3 | — |
| SECONDARY Number of Hair Follicles (Vertex) |
74.0 | — |
| SECONDARY Vellus Hairs (Frontal) |
1.5 | — |
| SECONDARY Vellus Hairs (Vertex) |
— | — |
| SECONDARY Terminal Hairs (Frontal) |
85.3 | — |
| SECONDARY Terminal Hairs (Vertex) |
117.5 | — |
Summary
To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia.
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
Data sourced from ClinicalTrials.gov (NCT04342091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.