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Treatment of frontal fibrosing alopecia with microneedling and photodynamic therapy using 5-aminolevulinic acid in male and female adult participants – an open single group phase 2 study

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506974-11-00
Enrollment
15
Registered
2024-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frontal fibrosing alopecia (FFA)

Brief summary

Reduction of the combined scoring of erythema and hyperkeratosis at week 32 compared to baseline (week 0)

Detailed description

Reduction of the combined scoring of erythema and hyperkeratosis at week 4, 8, 20 and 32 compared to baseline (week 0), Reduction of the (FFA) Global Staging Score week 32 compared to baseline (week 0), Change in investigators global assessment score week 32 compared to baseline (week 0), Change in patient global assessment score week 32 compared to baseline (week 0), Percentage reduction of hair density at week 32 (ALODEXFFA score) compared to baseline (week 0), Percentage change of hair density at week 4, 8, 20 and 32 (ALODEXFFA score) compared to baseline (week 0), Percentage increased hair density at week 32 compared to baseline (negative ALODEXFFA score)

Interventions

DRUGMetvix 160 mg/g Creme

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Reduction of the combined scoring of erythema and hyperkeratosis at week 32 compared to baseline (week 0)—

Secondary

MeasureTime frame
Reduction of the combined scoring of erythema and hyperkeratosis at week 4, 8, 20 and 32 compared to baseline (week 0), Reduction of the (FFA) Global Staging Score week 32 compared to baseline (week 0), Change in investigators global assessment score week 32 compared to baseline (week 0), Change in patient global assessment score week 32 compared to baseline (week 0), Percentage reduction of hair density at week 32 (ALODEXFFA score) compared to baseline (week 0), Percentage change of hair density at week 4, 8, 20 and 32 (ALODEXFFA score) compared to baseline (week 0), Percentage increased hair density at week 32 compared to baseline (negative ALODEXFFA score)—

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026