Total Area Hair Count (Frontal)
Primary
· 6 months
Total number of hairs over an area of 1cm\^2
| Group | Value | 95% CI |
|---|---|---|
| Microneedling | 86.8 | ± 73.0 |
Last reviewed · How we verify
NCT04342091
Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling
Completed
NA
Results posted
Last updated 13 April 2023
What this trial tests
NA trial testing SOL Nova Device in Fibrosing Alopecia in 6 participants. Completed in 8 April 2022.
Timeline
9 April 2021
Primary endpoint
8 April 2022
8 April 2022
8 April 2022
Quick facts
| Lead sponsor | Yale University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 9 April 2021 |
| Primary completion | 8 April 2022 |
| Estimated completion | 8 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SOL Nova Device
Conditions studied
- Fibrosing Alopecia — all drugs for Fibrosing Alopecia →
- Frontal Fibrosing Alopecia — all drugs for Frontal Fibrosing Alopecia →
- Central Centrifugal Cicatricial Alopecia — all drugs for Central Centrifugal Cicatricial Alopecia →
Sponsor
Yale University
Who can join
18 and older, female only, with Fibrosing Alopecia or Frontal Fibrosing Alopecia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total Area Hair Count (Vertex)
Primary
· 6 months
Total number of hairs over an area of 1 cm\^2
| Group | Value | 95% CI |
|---|---|---|
| Microneedling | 117.5 | ± 115.3 |
Hair Shaft Diameters (Frontal)
Secondary
· 6 months
Hair shaft diameter measured per trichoscopy
| Group | Value | 95% CI |
|---|---|---|
| Microneedling | 61.1 | ± 19.6 |
Hair Shaft Diameters (Vertex)
Secondary
· 6 months
Hair shaft diameter measured per trichoscopy
| Group | Value | 95% CI |
|---|---|---|
| Microneedling | 63.5 | ± 5.2 |
Number of Hair Follicles (Frontal)
Secondary
· 6 months
Number of hair follicles counted per 1cm\^2
| Group | Value | 95% CI |
|---|---|---|
| Microneedling | 70.3 | ± 59.6 |
Number of Hair Follicles (Vertex)
Secondary
· 6 months
Number of hair follicles per 1 cm\^2
| Group | Value | 95% CI |
|---|---|---|
| Microneedling | 74.0 | ± 53.7 |
Vellus Hairs (Frontal)
Secondary
· 6 months
Number of vellus hairs per cm\^2
| Group | Value | 95% CI |
|---|---|---|
| Microneedling | 1.5 | ± 3.0 |
Vellus Hairs (Vertex)
Secondary
· 6 months
Number of vellus hairs per cm\^2
| Group | Value | 95% CI |
|---|---|---|
| Microneedling | 0 | ± 0 |
Terminal Hairs (Frontal)
Secondary
· 6 months
Number of terminal hairs over an area of 1 cm\^2
| Group | Value | 95% CI |
|---|---|---|
| Microneedling | 85.3 | ± 74.6 |
Terminal Hairs (Vertex)
Secondary
· 6 months
Number of terminal hairs per area of 1 cm\^2
| Group | Value | 95% CI |
|---|---|---|
| Microneedling | 117.5 | ± 115.3 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Microneedling
Serious: 0/6 (0%)
Deaths: 0/6
Other adverse events (2 terms — click to expand)
| Reaction | System | Microneedling |
|---|---|---|
| Tongue Lesion (R Lateral Tongue) | Gastrointestinal disorders | — |
| Hair shedding | Skin and subcutaneous tissue disorders | — |
Data from ClinicalTrials.gov NCT04342091 adverse events section.
Sponsor's own description
To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04342091
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04342091 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yale University
- Last refreshed: 13 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04342091.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing