Metvixia (methyl aminolevulinate hydrochloride 16.8% cream) / Galderma - LARVOL DELTA

BOWTIE: Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease (clinicaltrials.gov) - P4 | N=250 | Completed | Sponsor: Maastricht University Medical Center | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Dec 2024

Trial completion • Trial completion date • Bowens Disease

Successful Treatment of MEK Inhibitor-Induced Paronychia in Neurofibromatosis with Photodynamic Therapy: A Case Report and Review of the Therapeutic Options. (PubMed, J Clin Med) - "Background/Objectives: Selumetinib, a MEK1/2 inhibitor, is commonly used for treating neurofibromatosis type 1 (NF1) and is associated with cutaneous side effects such as paronychia and periungual granulomas...PDT was administered using methyl aminolevulinate (METVIX®) as the photosensitizing agent, followed by treatment with a red LED light source (630 nm, 37 J/cm2 for 8 min and 30 s)...This case demonstrates that PDT can provide a complete resolution of symptoms with a single treatment session, offering an alternative to more invasive procedures. Further studies with larger cohorts are needed to establish PDT as a standard treatment option for this condition."

Journal • Genetic Disorders • Neurofibromatosis • Pain • Solid Tumor • NF1

Photodynamic therapy light': An enhanced treatment protocol for actinic keratoses with minimal pain and optimal clinical outcome by combining laser-assisted low irradiance PDT with shortened daylight PDT. (PubMed, Photodiagnosis Photodyn Ther) - "The novel 'PDT light' protocol proved to be an excellent and nearly painless method with an average visual-analogue scale (VAS) score of 1.19. Additional advantages included reduced illumination time, shorter outpatient stays in the clinic, fewer adverse effects, and better patient compliance than with DLPDT alone."

Clinical data • Journal • Actinic Keratosis • Dermatology • Oncology • Pain

Folliculotropic Mycosis Fungoides of the face successfully treated combining CO2 laser and conventional photodynamic therapy (c-PDT). (PubMed, Photodiagnosis Photodyn Ther) - "The procedure involved a CO2 laser (SmartXide DOT Deka) and the photosensitizing agent methyl aminolevulinate (MAL) (METVIX 160 mg/g Cream, Galderma Medical), in conjunction with a red light-emitting diode lamp (Aktilite CL128, Galderma, wavelength 630 nm). The primary endpoint was the clinical remission of the lesions; the secondary one the evaluation of treatment tolerance, measured using the 11-point (0-10) Numeric Rating Scale (NRS) for burning/pain, heat, and swelling. After a single treatment session and four weeks of follow-up, the patient's facial lesions achieved complete clinical remission."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Mycosis Fungoides • Oncology • Pain

Successful Treatment of Hailey-Hailey Disease with Photodynamic Therapy: A Case Report (EADV 2024) - "We performed PDT treatment in the axillary and left sub-mammary regions following methyl aminolevulinate (Metvixia®) application in a thin layer under occlusion for 3 hours... Typically, patients with HHD present with flaccid vesicopustules, crusted erosions, macerations, or fissures in friction-prone skin folds. Treatment of HHD is often challenging and disappointing. PDT appears to offer new perspectives in this challenging context."

Case report • Clinical • Anesthesia • Genetic Disorders • Pain

Efficacy of photodynamic therapy using ALAHCl in gel with a lipid nanoemulsion and MALHCl in cream in superficial basal cell carcinoma. (PubMed, Ann Agric Environ Med) - "Both formulations - ALA-HCl in gel and MAL-HCl in cream - were highly effective photosensitisers for PDT. The advantage of ALA-HCl in a gel formulation with a lipid nanoemulsion was faster skin healing, resulting in better cosmetic results."

Journal • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis (clinicaltrials.gov) - P=N/A | N=224 | Completed | Sponsor: Galderma Laboratorium GmbH | Recruiting ➔ Completed | N=350 ➔ 224

Enrollment change • Trial completion • Actinic Keratosis • Dermatology

Keratolytics can replace curettage in daylight photodynamic therapy for actinic keratosis on the face/scalp: A randomized clinical trial. (PubMed, J Eur Acad Dermatol Venereol) - "According to our results, curettage is not necessary to obtain the full treatment effect of n-DL-PDT. We experienced in a real-life setting that n-DL-PDT protocol could be changed by replacing curettage with keratolytics."

Clinical • Journal • Actinic Keratosis • Dermatology • Pain

New Treatments for Actinic Keratoses of the Scalp (clinicaltrials.gov) - P=N/A | N=120 | Active, not recruiting | Sponsor: Helsinki University Central Hospital | Trial completion date: Jul 2024 ➔ Dec 2024

Trial completion date • Actinic Keratosis • Dermatology

Dermaris-35: Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ® (clinicaltrials.gov) - P=N/A | N=25 | Completed | Sponsor: Centre Dermatologique du Roy | Recruiting ➔ Completed | Trial primary completion date: Dec 2022 ➔ Jun 2023

Trial completion • Trial primary completion date • Actinic Keratosis • Dermatology

A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study (clinicaltrials.gov) - P3 | N=125 | Terminated | Sponsor: Galderma R&D | Completed ➔ Terminated; The study was terminated early as per Sponsor's decision

Trial termination • Actinic Keratosis • Dermatology

Photodynamic therapy with BF-200 ALA and red-light for the treatment of non-aggressive BCCs: 5-year follow-up data of a randomized, controlled, comparative multicenter phase-III-trial (EADV 2023) - P3 | "Materials & 272 adult subjects with 1-3 primary nodular or superficial BCCs ≤2 mm thickness on face/scalp, neck/trunk or extremities were randomized (1:1) to receive up to 4 PDTs with 7.8% aminolevulinic acid (ALA) gel (BF-200 ALA) or 16% methyl-aminolevulinate (MAL) cream. The initial and sustainable high clearance rates and the high patient satisfaction demonstrate that PDT is an effective and sustainable treatment option for BCCs."

Clinical • P3 data • Basal Cell Carcinoma • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • Skin Cancer

ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis (clinicaltrials.gov) - P=N/A | N=350 | Recruiting | Sponsor: Galderma Laboratorium GmbH | Trial completion date: Jun 2023 ➔ Oct 2023 | Trial primary completion date: Jun 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date • Actinic Keratosis • Dermatology

PDT Light: minimal pain, maximal effect. An enhanced method of a laser-assisted very-low-irradiance-PDT, combined with a shortened daylight illumination (WCD 2023) - "7.6 +/-1,5 by a different author) at face and scalp during illumination after using MAL-cream and the Aktilite-LED with a fluence rate of 74 mW/cm² and dose of 37 J/cm²...PDT-Light proves to be an excellent and nearly painless average-VAS-score 1.42. Further advantages: reduced time of treatment, less side effects, better control than Daylight-PDT"

Actinic Keratosis • Dermatology • Oncology • Pain

Photodynamic Therapy of Acne Using Methyl Aminolevulinate Hydrochloride cream in Korean Adolescent Patients (WCD 2023) - "PDT may be an effective and safe treatment for adolescent acne patients who are difficult to treat with oral antibiotics or retinoid-based topical agents."

Clinical • Acne Vulgaris • Dermatology

A Review of MAL-PDT for the Treatment Strategy of Actinic Keratosis: Broader Clinical Perspectives Beyond the Data and Guideline Recommendations. (PubMed, Dermatol Ther (Heidelb)) - "Here, we used PubMed to search MEDLINE to identify guidelines, consensus recommendations, and studies describing the use of MAL for the treatment of AK. The aim of this targeted review is to consider various MAL-PDT treatment strategies on the basis of published literature, with a focus on personalizing treatment for the heterogeneous AK population."

Journal • Review • Actinic Keratosis • Dermatology • Non-melanoma Skin Cancer • Oncology

ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis (clinicaltrials.gov) - P=N/A | N=350 | Recruiting | Sponsor: Galderma Laboratorium GmbH

New trial • Actinic Keratosis • Dermatology

Topical and Intralesional photodynamic therapy for hidradenitis suppurativa: A retrospective case series study of the University Hospital Son Espases. (EHSF 2023) - "Fistulas were classified according to Martorell et al.1 In superficial lesions, 5-aminolevulinic acid (ALA, Ameluz®) or methyl aminolevulinate (MAL, Metvix®) were used as topical sensitizers. A third option for lesions deeper than 8mm could be the use of intralesional ALA and intralesional diode laser of 630nm. PDT seems to be cost-effective, safe, and well-tolerated local therapy for Hurley I-II patients with both acute inflammatory lesions and fistulas, although more prospective studies, with higher sample sizes and standardized outcomes are needed to provide more scientific evidence."

Retrospective data • Dermatology • Hidradenitis Suppurativa • Immune Modulation • Inflammation • Pain

Dermaris-35: Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ® (clinicaltrials.gov) - P=N/A | N=25 | Recruiting | Sponsor: Centre Dermatologique du Roy

New trial • Actinic Keratosis • Dermatology

New Treatments for Actinic Keratoses of the Scalp (clinicaltrials.gov) - P=N/A | N=120 | Active, not recruiting | Sponsor: Helsinki University Central Hospital

New trial • Actinic Keratosis • Dermatology

PhotodiVIN: Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia (clinicaltrials.gov) - P2; N=17; Recruiting; Sponsor: Institut de Cancérologie de Lorraine; Not yet recruiting ➔ Recruiting

Enrollment open • Gynecologic Cancers • Oncology • Vulvar Cancer

PhotodiVIN: Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia (clinicaltrials.gov) - P2; N=17; Not yet recruiting; Sponsor: Institut de Cancérologie de Lorraine

New P2 trial • Gynecologic Cancers • Oncology • Vulvar Cancer

A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study (clinicaltrials.gov) - P3; N=130; Completed; Sponsor: Galderma R&D; Active, not recruiting ➔ Completed

Clinical • Trial completion • Actinic Keratosis • Dermatology

Optimizing treatment of acne with photodynamic therapy (PDT) to achieve long-term remission and reduce side effects. A prospective randomized controlled trial. (PubMed, J Photochem Photobiol B) - "A 1.5-h pre-treatment with the MAL cream was followed by illumination with red light (20 J/cm)...In comparison to baseline, the number of inflammatory lesions at 20 weeks on cheeks treated with MAL-PDT showed a relative decrease of 74% in the group with two treatments and 85% in the group with four treatments. This new treatment regimen for both MAL-PDT and red-light-only PDT, with shortened pre-treatment and reduced light dose, could be an effective modality."

Adverse events • Clinical • Journal • Acne Vulgaris • Dermatology

A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study (clinicaltrials.gov) - P3; N=129; Active, not recruiting; Sponsor: Galderma R&D; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Actinic Keratosis • Dermatology