METHYL AMINOLEVULINATE HYDROCHLORIDE for Frontal fibrosing alopecia

Inclusion criteria

• {"criterion_text":"- The participant must be ≥18 years of age at the time of signing the informed consent\n- The participant must fulfill the criteria for classic FFA with a grade 2 or 3 of erythema and hyperkeratosis\n- The participant must be able to communicate in Norwegian or English\n- The participant must be capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n- Females of reproductive age must use effective"}

Exclusion criteria

• {"criterion_text":"- The participant has another medical condition in the area of interest on the scalp, making MN/PDT contraindicated (e.g., melanoma, morpheaform or other invasive keratinocyte carcinoma)\n- The patient has received systemic anti-inflammatory therapy (e.g., glucocorticoids, calcineurin inhibitors, ciclosporin A, azathioprine, methotrexate, anti-TNF, anti-interleukins JAK inhibitors or retinoids) within the last 12 weeks. NSAIDs are acceptable\n- The patient has another medical condition in the area of interest on the scalp, making the effects of MN/PDT difficult to interpret (e.g., psoriasis, seborrheic dermatitis)\n- The patient has another medical condition making MN/PDT contraindicated even if the area of interest is not affected at screening (e.g., cutaneous lupus, porphyria cutanea tarda or other porphyria)\n- The participant is pregnant or wish to become pregnant or is breastfeeding within the time frame of the study\n- The participant has current hypertension of ≥160/100 mm Hg\n- Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures\n- The patient has received topical corticosteroids or calcineurin inhibitors on the area of interest less than four weeks ago\n- The patient has received systemic 5-alpha reductase inhibitors less than twelve weeks ago\n- The patient has received topical anti-neoplastic therapy in the area of interest (e.g., imiquimod, 5-fluorouracil, PDT) within the last 12 weeks"}

Primary endpoints

• {"endpoint_text":"- Reduction of the combined scoring of erythema and hyperkeratosis at week 32 compared to baseline (week 0)","definition_or_measurement_approach":"Combined scoring of erythema and hyperkeratosis measured at week 32 compared to baseline (week 0) as stated in the endpoint text."}

Secondary endpoints

• {"endpoint_text":"- Reduction of the combined scoring of erythema and hyperkeratosis at week 4, 8, 20 and 32 compared to baseline (week 0)","definition_or_measurement_approach":"Combined scoring of erythema and hyperkeratosis measured at weeks 4, 8, 20 and 32 compared to baseline (week 0)."}
• {"endpoint_text":"- Reduction of the (FFA) Global Staging Score week 32 compared to baseline (week 0)","definition_or_measurement_approach":"FFA Global Staging Score measured at week 32 compared to baseline (week 0)."}
• {"endpoint_text":"- Change in investigators global assessment score week 32 compared to baseline (week 0)","definition_or_measurement_approach":"Investigator global assessment score change at week 32 versus baseline (week 0)."}
• {"endpoint_text":"- Change in patient global assessment score week 32 compared to baseline (week 0)","definition_or_measurement_approach":"Participant global assessment score change at week 32 versus baseline (week 0)."}
• {"endpoint_text":"- Percentage reduction of hair density at week 32 (ALODEXFFA score) compared to baseline (week 0)","definition_or_measurement_approach":"Percentage reduction in hair density measured by ALODEXFFA score at week 32 compared to baseline (week 0)."}
• {"endpoint_text":"- Percentage change of hair density at week 4, 8, 20 and 32 (ALODEXFFA score) compared to baseline (week 0)","definition_or_measurement_approach":"Percentage change in hair density by ALODEXFFA score at weeks 4, 8, 20 and 32 versus baseline (week 0)."}
• {"endpoint_text":"- Percentage increased hair density at week 32 compared to baseline (negative ALODEXFFA score)","definition_or_measurement_approach":"Percentage increase in hair density (negative ALODEXFFA score) at week 32 compared to baseline."}

Norway

Earliest CTIS Part Ii Submission Date

16-01-2024

Latest Decision Or Authorization Date

30-01-2024

Processing Time Days

14

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"Norway","full_name":"Oslo University Hospital HF","duties_or_roles":"1,5,6","organisation_type":"Hospital/Clinic/Other health care facility"}