METVIXIA SUMMARY
METVIXIA™ (methyl aminolevulinate) Cream, 16.8%
For Topical Use Only.
Not for Ophthalmic, Oral, or Intravaginal Use
Must be dispensed to and applied by a physician.
Metvixia Cream is an oil in water emulsion. Metvixia Cream contains methyl aminolevulinate hydrochloride equivalent to 168 mg/g of methyl aminolevulinate.
Metvixia Cream in combination with 570 to 670 nm wavelength red light illumination using the CureLight BroadBand Model CureLight 01 lamp is indicated for treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette) in the physician’s office when other therapies are unacceptable or considered medically less appropriate.
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NEWS HIGHLIGHTS
Published Studies Related to Metvixia (Methyl Aminolevulinate Topical)
Photodynamic therapy with methylaminolevulinate 80 mg/g without occlusion improves acne vulgaris. [2010.11]
BACKGROUND: Photodynamic therapy (PDT) with methylaminolevulinate (MAL) under occlusion is effective for the treatment of acne vulgaris but is associated with significant phototoxic side effects. OBJECTIVE: To evaluate the safety and efficacy of topical MAL with or without occlusion followed by red light exposure in patients with facial acne vulgaris... CONCLUSION: PDT with MAL at 80 mg/g without occlusion reduces the number of inflammatory lesions in patients with facial acne vulgaris.
Effects of photodynamic therapy using topical applied hexylaminolevulinate and methylaminolevulinate upon the integrity of cervical epithelium. [2010.11]
BACKGROUND AND OBJECTIVE: Cervical intraepithelial neoplasia (CIN) is associated with genital human papillomavirus (HPV) infection and represents the precursor of cervical cancer. Established ablative treatment methods may cause substantial complications in following pregnancies including premature delivery and the birth of low-weight babies. Photodynamic therapy (PDT) of CIN using esters of 5-aminolevulinic acid (5-ALA) represents a promising alternative. However, it has not been analyzed yet if the PDT itself leads to sustained damage of the cervical tissue. This study aims at evaluating the effect of hexylaminolevulinate (HAL) and methylaminolevulinate (MAL) PDT on cervical tissue... CONCLUSIONS: HAL and MAL PDT do not leave any sustained damage in normal cervical tissue. This is of paramount importance as cervical insufficiency or stenosis may have implications on pregnancy and cervical cancer screening. (c) 2010 Wiley-Liss, Inc.
Photorejuvenation with topical methyl aminolevulinate and red light: a randomized, prospective, clinical, histopathologic, and morphometric study. [2010]
CONCLUSION: Clinical improvement with regard to texture, firmness, wrinkle depth, skin coloration, and clearance of actinic keratoses was observed. Histopathologic and morphometric studies were consistent with the clinical findings.
Photodynamic therapy with methyl aminolevulinate for primary nodular basal cell carcinoma: results of two randomized studies. [2009.11]
BACKGROUND: Data suggest that photodynamic therapy using topical methyl aminolevulinate (MAL PDT) may be a noninvasive alternative to excisional surgery for nodular basal cell carcinoma (BCC). In the studies described here, we investigated the histologic response, tolerability, and cosmetic outcome with MAL PDT for primary nodular BCC (<or= 5 mm in depth)... CONCLUSION: Although longer follow-up studies are required, these promising data indicate the potential of topical MAL PDT as a noninvasive treatment alternative for nodular BCC.
Topical methyl aminolevulinate photodynamic therapy using red light-emitting diode light for multiple actinic keratoses: a randomized study. [2009.04]
CONCLUSIONS: Topical MAL PDT using a LED is an effective treatment for multiple AKs.
Clinical Trials Related to Metvixia (Methyl Aminolevulinate Topical)
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix� Photodynamic Therapy (PDT) [Completed]
The aim of this study is to determine possible molecular changes on large scale gene
expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic
keratoses (AK) and cancerised field in renal transplant recipients.
Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage [Completed]
Superficial Basal Cell Carcinoma Treatment With Topical Photodynamic Therapy With Fractionated 5-aminolevulinic Acid 20% Versus Two Stage Methylaminolevulinate [Recruiting]
Skin cancer is the most common cancer in Caucasians, and a basal cell carcinoma (BCC) being
the most common skin cancer with around 44,000 new tumours per year, and its incidence is
still rising. In the past it has been a disease of the elderly patient but as a consequence
of recreational sun exposure and tanning beds, more young patients develop a skin cancer as
well. There are different subtypes of BCC and most subtypes are treated by surgical
excision. Nowadays, non-invasive techniques as photodynamic therapy (PDT) are common
practice to treat superficial BCC (sBCC). Because of these techniques treatment by surgical
excision can be avoided with the possibility of complications and scar formation. Both
5-aminolevulino acid (5-ALA) and the more lipophilic methyl aminolevulinate (MAL) can be
used as a precursor of the photosensitiser. These agents generate an excess of
protoporphyrin IX in metabolic active cells, which are illuminated by a specific light
source leading to release of reactive oxygen radicals in tissue. The result is apoptosis and
necrosis of tumour cells. At the moment, two treatment protocols are used in the
Netherlands: the fractionated 5-ALA 20% (Fagron) protocol according to de Haas and the MAL
(Metvix, Galderma) protocol. Because MAL was first marketed and registered as a treatment
option for premalignant and superficial malignancies most hospitals in the Netherlands use
this topical agent. However, there is no evidence which of the 2 agents is more
(cost-)effective and/ or preferred by patients.
Objective: to determine which treatment is the most effective treatment in terms of
prevention of treatment failure, cost saving and patients preference when comparing
fractionated 5-ALA 20% PDT versus MAL PDT in 2 treatment sessions.
Photodynamic Therapy Using Methyl-5-Aminolevulinate Hydrochloride Cream in Determining Pain Threshold in Patients With Skin Cancer [Completed]
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a
certain kind of light. When the drug is active, cancer cells are killed. Photodynamic
therapy using methyl-5-aminolevulinate hydrochloride cream may be effective against skin
cancer. PURPOSE: This phase I trial is studying the side effects and best dose of
photodynamic therapy with methyl-5-aminolevulinate hydrochloride cream in determining pain
threshold patients with skin cancer
Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion [Completed]
Actinic keratoses on the face are often numerous and widespread. The application of
Methylaminolevulinate (MAL) on individual lesions followed by the application of a plastic
film on each lesion is difficult and takes time for subjects with many actinic keratoses.
The waiting period of 3 hours between MAL cream application and red light exposure is also
long for patients. The goal of this study is to evaluate the safety and efficacy of
photodynamic therapy (PDT) with MAL with a shorter cream application time (90 minutes) and
when MAL is applied on the entire face without the plastic film.
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