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Study on Treating Frontal Fibrosing Alopecia in Adults Using Microneedling and Photodynamic Therapy with Methyl Aminolevulinate Hydrochloride

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of frontal fibrosing alopecia (FFA), a condition that leads to hair loss, particularly affecting the front hairline. The treatment being tested involves a combination of microneedling and photodynamic therapy. Photodynamic therapy uses a special cream called Metvix 160 mg/g Creme, which contains the active ingredient methyl aminolevulinate hydrochloride. This cream is applied to the skin and activated by light to help reduce inflammation and improve the condition of the scalp.

The purpose of the study is to see if this treatment can reduce the inflammation caused by FFA over a period of 32 weeks. Participants in the study will receive the treatment and be monitored at various intervals to assess changes in their condition. The study aims to observe improvements in symptoms such as redness and skin thickening, as well as changes in hair density and overall scalp health.

Throughout the study, participants will be evaluated to track the progress of their treatment. The goal is to determine if the combination of microneedling and photodynamic therapy with Metvix can effectively manage the symptoms of frontal fibrosing alopecia and improve the quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant must be at least 18 years old and meet the criteria for classic frontal fibrosing alopecia (FFA) with a grade 2 or 3 of redness and skin thickening.
The participant must be able to communicate in Norwegian or English and provide signed informed consent.
Step 2
Treatment initiation
The treatment involves the use of Metvix 160 mg/g Creme, which contains the active substance methyl aminolevulinate hydrochloride.
The cream is applied topically, meaning it is applied directly to the skin.
Step 3
Microneedling and photodynamic therapy
Participants undergo microneedling, a procedure that uses small needles to create tiny punctures in the skin, followed by photodynamic therapy.
Photodynamic therapy involves the application of the cream followed by exposure to a specific type of light to activate the medication.
Step 4
Monitoring and assessment
The primary goal is to reduce inflammation due to FFA by week 32 compared to the start of the study.
Assessments occur at weeks 4, 8, 20, and 32 to evaluate the reduction of redness and skin thickening, as well as changes in hair density and global assessment scores.
Step 5
Completion of the study
The study is expected to end by December 31, 2025.
Final evaluations will compare the condition at week 32 to the baseline measurements taken at the start of the study.

Who can join the trial?

5 criteria

The participant must be at least 18 years old at the time of signing the informed consent.
The participant must meet the criteria for classic Frontal Fibrosing Alopecia (FFA) with a grade 2 or 3 of erythema and hyperkeratosis. Erythema means redness of the skin, and hyperkeratosis means thickening of the outer layer of the skin.
The participant must be able to communicate in Norwegian or English.
The participant must be capable of giving signed informed consent, which means they understand and agree to the study's requirements and restrictions.
Females of reproductive age must use effective birth control methods.

Who cannot join the trial?

4 criteria

Individuals who do not have frontal fibrosing alopecia (FFA), a specific type of hair loss condition.
Individuals who are not within the specified age range for the study.
Individuals who do not meet the gender requirements for the study.
Individuals who are considered part of a vulnerable population, meaning they might need special protection or care.

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Investigated drugs

Microneedling
is a therapy that involves using tiny needles to create small punctures in the skin. This process is believed to stimulate the skin's natural healing process, which can help improve hair growth and reduce inflammation in conditions like frontal fibrosing alopecia.
Photodynamic Therapy with 5-Aminolevulinic Acid
involves applying a special cream containing 5-aminolevulinic acid to the affected area. After the cream is absorbed, the area is exposed to a specific type of light. This combination is thought to help reduce inflammation and promote hair growth in people with frontal fibrosing alopecia.

Methyl Aminolevulinate Hydrochloride

What is already known about the treatment

5-Aminolevulinic Acid – This medication is administered topically and is used in combination with photodynamic therapy, where it is applied to the skin and activated by light. It is currently being studied in clinical trials for its effectiveness in treating frontal fibrosing alopecia, a condition characterized by hair loss and inflammation. The main therapeutic indication is to reduce inflammation associated with this type of alopecia. At the molecular level, 5-aminolevulinic acid works by being converted into a compound that produces reactive oxygen species when exposed to light, which helps to target and reduce inflammation. It is classified as a photosensitizing agent in pharmacology.

Investigated diseases

Frontal Fibrosing Alopecia – Frontal fibrosing alopecia is a type of hair loss that primarily affects the front and sides of the scalp, often leading to a receding hairline. It is characterized by the gradual loss of hair and can also involve the eyebrows and other body hair. The condition is thought to be a form of lichen planopilaris, an inflammatory condition that affects hair follicles. Over time, the inflammation can lead to scarring, which prevents hair from regrowing in the affected areas. The progression of the disease can vary, with some individuals experiencing slow changes, while others may notice more rapid hair loss. The exact cause of frontal fibrosing alopecia is not well understood, but it is believed to involve a combination of genetic and environmental factors.