Authorised Therapeutic exploratory (Phase II) Frontal fibrosing alopecia (FFA)

Treatment of frontal fibrosing alopecia with microneedling and photodynamic therapy

EU CTIS ID: 2023-506974-11-00

What this study is testing

Reduction of inflammation due to frontal fibrosing alopecia (FFA) at week 32 compared to baseline

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.