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

Oslo University Hospital HF0 个研究点目标入组 15 人开始时间: 2023年10月17日最近更新: 2024年7月22日

试验速览

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•The participant must be =18 years of age at the time of signing the informed consent, The participant must fulfill the criteria for classic FFA with a grade 2 or 3 of erythema and hyperkeratosis, The participant must be able to communicate in Norwegian or English, 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, Females of reproductive age must use effective

•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), 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, 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), 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), The participant is pregnant or wish to become pregnant or is breastfeeding within the time frame of the study, The participant has current hypertension of =160/100 mm Hg, Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures, The patient has received topical corticosteroids or calcineurin inhibitors on the area of interest less than four weeks ago, The patient has received systemic 5-alpha reductase inhibitors less than twelve weeks ago, The patient has received topical anti-neoplastic therapy in the area of interest (e.g., imiquimod, 5-fluorouracil, PDT) within the last 12 weeks

发起方

Oslo University Hospital HF