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Methyl Aminolevulinate Hydrochloride

This article discusses a clinical trial investigating the use of Methyl Aminolevulinate Hydrochloride, a drug found in Metvix 160 mg/g Cream, for treating frontal fibrosing alopecia (FFA). The study combines microneedling and photodynamic therapy to potentially reduce inflammation and improve hair density in adult patients with FFA. This phase II trial aims to evaluate the effectiveness of this innovative approach in managing this challenging hair loss condition.

Table of Contents

What is Methyl Aminolevulinate Hydrochloride?

Methyl Aminolevulinate Hydrochloride is a medication used in a treatment called photodynamic therapy (PDT). It’s available as a cream called Metvix, which contains 160 mg/g of the active substance.[1] This medication is also known by its chemical name, (4-methoxycarbonyl-2-oxo-butyl)azanium chloride.[1]

Frontal Fibrosing Alopecia

Frontal Fibrosing Alopecia (FFA) is a medical condition that this treatment aims to address. FFA is a type of hair loss that affects the front part of the scalp, leading to a receding hairline. It’s characterized by inflammation and scarring in the affected area.[1]

Treatment Approach

The treatment approach being studied combines two methods:

  1. Microneedling (MN): This involves using tiny needles to create small punctures in the skin, which can stimulate healing and potentially improve the absorption of medications.
  2. Photodynamic Therapy (PDT): This uses Methyl Aminolevulinate Hydrochloride cream along with light exposure to target and treat the affected areas.

The treatment is applied topically (on the skin) to the affected areas of the scalp.[1]

Eligibility Criteria

To be eligible for this treatment, patients must meet certain criteria:

  • Be at least 18 years old
  • Have classic FFA with moderate to severe redness and scaling (grade 2 or 3 of erythema and hyperkeratosis)
  • Be able to communicate in Norwegian or English
  • Be capable of giving informed consent
  • If female and of reproductive age, use effective contraception

Some conditions that would prevent a person from being eligible include:

  • Having certain skin conditions in the treatment area (like melanoma or other skin cancers)
  • Recent use of certain medications (like systemic anti-inflammatory drugs or topical corticosteroids)
  • Pregnancy or breastfeeding
  • High blood pressure (160/100 mm Hg or higher)

These criteria ensure that the treatment is safe and appropriate for the participants.[1]

Treatment Goals

The main goal of this treatment is to reduce inflammation caused by FFA. Specifically, the study aims to:

  • Reduce redness and scaling in the affected area
  • Improve the overall appearance of FFA
  • Slow down or stop the progression of hair loss
  • Potentially increase hair density in some cases

These goals will be measured at various time points throughout the study, with the main assessment occurring at 32 weeks after starting treatment.[1]

Potential Benefits

While the effectiveness of this treatment is still being studied, potential benefits may include:

  • Reduction in scalp inflammation
  • Improvement in the appearance of the hairline
  • Slowing or stopping of further hair loss
  • Possible regrowth of hair in some cases

It’s important to note that individual results may vary, and the full extent of benefits will be determined through the ongoing clinical trial.[1]

Aspect Details
Drug Name Methyl Aminolevulinate Hydrochloride (Metvix 160 mg/g Cream)
Condition Studied Frontal Fibrosing Alopecia (FFA)
Treatment Approach Microneedling and Photodynamic Therapy
Primary Objective Reduction of FFA inflammation at week 32 compared to baseline
Key Eligibility Criteria Adults ≥18 years, classic FFA with grade 2 or 3 erythema and hyperkeratosis
Primary Endpoint Reduction in combined scoring of erythema and hyperkeratosis at week 32
Secondary Endpoints Changes in FFA Global Staging Score, hair density, and patient/investigator assessments
Treatment Duration 32 weeks with assessments at weeks 0, 4, 8, 20, and 32
Drug Administration Topical application, maximum 2 ml daily, 8 ml total
Trial Phase Phase II

FAQ

  • What is frontal fibrosing alopecia (FFA)? Frontal fibrosing alopecia (FFA) is a type of hair loss condition that affects the front of the scalp, causing inflammation and scarring. It typically leads to a receding hairline and can be challenging to treat.
  • How is Methyl Aminolevulinate Hydrochloride being used in this clinical trial? In this trial, Methyl Aminolevulinate Hydrochloride is being used in combination with microneedling and photodynamic therapy to treat frontal fibrosing alopecia. The drug is applied topically to the affected area of the scalp.
  • What are the main objectives of this clinical trial? The main objective is to reduce inflammation caused by FFA at week 32 compared to baseline. Secondary objectives include monitoring changes in FFA inflammation over time, assessing changes in FFA Global Staging Score, and evaluating both the investigator's and participant's overall disease activity assessments.
  • Who is eligible to participate in this clinical trial? Eligible participants must be 18 years or older, have classic FFA with grade 2 or 3 erythema and hyperkeratosis, be able to communicate in Norwegian or English, and provide informed consent. Females of reproductive age must use effective contraception.
  • How long does the treatment period last in this clinical trial? The treatment period lasts for 32 weeks, with assessments made at baseline (week 0) and at weeks 4, 8, 20, and 32. The maximum treatment period with the drug is 1 day, as it is applied topically during the photodynamic therapy sessions.

Ongoing Clinical Trials on Methyl Aminolevulinate Hydrochloride

  • Study on the Effectiveness and Safety of Metformin and Methyl Aminolevulinate in Daylight Therapy for Actinic Keratosis Patients

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

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

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway

Glossary

  • Frontal Fibrosing Alopecia (FFA): A type of scarring hair loss that primarily affects the front of the scalp, leading to a receding hairline. It is characterized by inflammation and scarring of hair follicles.
  • Microneedling: A cosmetic procedure that involves creating tiny punctures in the skin using small needles, which can stimulate collagen production and improve absorption of topical treatments.
  • Photodynamic Therapy (PDT): A treatment that combines light-sensitive drugs (photosensitizers) and light to destroy specific cells, often used in dermatology for various skin conditions.
  • Methyl Aminolevulinate Hydrochloride: The active ingredient in Metvix cream, used as a photosensitizer in photodynamic therapy for various skin conditions.
  • Erythema: Redness of the skin caused by increased blood flow to superficial capillaries, often a sign of inflammation or irritation.
  • Hyperkeratosis: Thickening of the outer layer of the skin, which can appear as rough, scaly patches.
  • Global Staging Score: A standardized method used to assess the severity and progression of a medical condition, in this case, Frontal Fibrosing Alopecia.
  • ALODEXFFA score: A measure used to evaluate hair density changes in patients with Frontal Fibrosing Alopecia.
  • Topical administration: Application of a medication directly to the skin or mucous membranes, as opposed to oral or injectable routes.
  • Phase II clinical trial: A stage of clinical research that focuses on evaluating the effectiveness and side effects of a treatment in a larger group of patients with the condition being studied.

References

  1. http://clinicaltrials.eu/trial/study-on-treating-frontal-fibrosing-alopecia-in-adults-using-microneedling-and-photodynamic-therapy-with-methyl-aminolevulinate-hydrochloride/