24 completed, 3 unknown, 1 no longer available, 1 terminated. 8 Phase 3, 7 Phase 2, 6 Phase 4, 5 Not applicable, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 8 |
| Phase 2 | 7 | Completed 6, Unknown 1 |
| Phase 4 | 6 | Completed 4, Terminated 1, Unknown 1 |
| Not applicable | 5 | Completed 4, Unknown 1 |
| Phase 1 | 3 | Completed 2, Unknown 1 |
Follow methyl 5-aminolevulinate: new trials by email Literature Review of methyl 5-aminolevulinate trials Research Report on methyl 5-aminolevulinate
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| ADL-PDT Under Routine Clinical Conditions in Patients With Actinic Keratosis Metvix® 160 mg/g Creme - Actinic Keratoses | Completed | Galderma Laboratorium GmbH | 224 | 2022-11-01 | 2024-02-23 | |
| Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing PDT of AK Using the Dermaris ® Metvix + Dermaris - Actinic Keratoses | Not applicable | Completed | Centre Dermatologique du Roy | 25 | 2022-01-01 | 2023-10-18 |
| Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease Methyl Aminolevulinate (Mal) for Topical Administration, 16.8%, 1 Gram, 5Fluorouracil, Surgical excision - Bowen's Disease | Phase 4 | Completed | Maastricht University Medical Center | 250 | 2019-05-27 | 2025-05-06 |
| PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK Methyl Aminolaevulinate 16% Cream - Actinic Keratoses | Phase 4 | Completed | Galderma R&D | 50 | 2017-06-07 | 2021-02-18 |
| Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization Methyl Aminolevulinate - Actinic Keratosis | Not applicable | Unknown | University of Sao Paulo General Hospital | 20 | 2016-09-01 | 2017-01-06 |
| Metvix Daylight PDT in Actinic Keratosis Metvix - Actinic Keratosis | Completed | Galderma R&D | 406 | 2015-09-01 | 2021-02-17 | |
| Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL) Aminolevulinic Acid, Methyl 5-aminolevulinate - Actinic Keratosis, Natural Daylight Photodynamic Therapy | Phase 4 | Completed | Joint Authority for Päijät-Häme Social and Health Care | 72 | 2015-06-01 | 2019-08-28 |
| Actinic Keratoses Treatment With Metvix® in Combination With Light Metvix®, Photodynamic Therapy Blue light, Photodynamic Therapy Daylight - Actinic Keratoses | Phase 3 | Completed | University Hospital, Limoges | 26 | 2015-03-25 | 2025-07-29 |
| Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL Hexylaminolevulinate cream, Aminolevulinic Acid Nano Emulsion, Methylaminolevulinate cream - Neoplasms, Basal Cell, Carcinoma, Basal Cell | Phase 1 / Phase 2 | Unknown | Joint Authority for Päijät-Häme Social and Health Care | 117 | 2015-03-01 | 2019-03-28 |
| Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial full ablative CO2 laser, fractional ablative CO2 laser, MAL - Bowen's Disease, Superficial Basal Cell Carcinoma | Not applicable | Completed | University Hospital, Ghent | 16 | 2014-09-01 | 2018-01-25 |
| Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL Hexylaminolaevulinate cream, Methylaminolaevulinate cream - Actinic Keratoses | Phase 1 / Phase 2 | Completed | Joint Authority for Päijät-Häme Social and Health Care | 14 | 2014-05-01 | 2016-07-11 |
| Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage Methyl Aminolevulinate (MAL), Placebo - Facial Photodamage | Phase 2 | Completed | Fundación Dermabase | 60 | 2014-04-01 | 2015-03-06 |
| Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy BF-200 ALA, methyl-aminolevulinate - Basal Cell Carcinoma (BCC) | Phase 3 | Completed | Biofrontera Bioscience GmbH | 281 | 2014-01-28 | 2022-11-03 |
| Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL) BF-200 ALA cream, MAL cream - Multiple Actinic Keratoses | Phase 4 | Completed | Joint Authority for Päijät-Häme Social and Health Care | 14 | 2013-08-01 | 2016-07-11 |
| Superficial Basal Cell Carcinoma Treatment With Topical Photodynamic Therapy With Fractionated 5-aminolevulinic Acid 20% Versus Two Stage Methylaminolevulinate Methylaminolevulinate PDT in 2 sessions, Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT - Superficial Basal Cell Carcinoma | Phase 4 | Unknown | Maastricht University Medical Center | 162 | 2013-08-01 | 2014-01-31 |
| Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients photodynamic therapy, imiquimod 5% cream - Actinic Keratoses | Phase 4 | Terminated | Medical University of Vienna | 10 | 2012-09-01 | 2017-09-12 |
| New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC) MAL-PDT re-treatment, usual MAL-PDT - Skin Neoplasms, Carcinoma, Basal Cell | Not applicable | Completed | Norwegian University of Science and Technology | 277 | 2012-06-01 | 2017-10-27 |
| Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses Metvix and natural daylight PDT, Metvix and conventional PDT - Actinic Keratoses | Phase 3 | Completed | Galderma R&D | 100 | 2012-03-01 | 2021-02-18 |
| Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion Methylaminolevulinate (Metvix, Metvixia), Photodynamic Therapy (Aktilite) - Actinic Keratosis | Phase 3 | Completed | Innovaderm Research Inc. | 20 | 2009-07-01 | 2011-09-09 |
| A Randomized Multicenter Study of Daylight Mediated Photodynamic Therapy (PDT) Photodynamic therapy with methyl aminolevulinate - Actinic Keratoses | Not applicable | Completed | Bispebjerg Hospital | 150 | 2008-06-01 | 2010-11-02 |
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Keratosis, Actinic (14) · Carcinoma, Basal Cell (7) · Bowen's Disease (4) · Acne Vulgaris (2) · Carcinoma (1) · Carcinoma, Squamous Cell (1) · Connective Tissue Diseases (1) · Keratosis (1) · Neoplasms, Basal Cell (1) · Skin Diseases (1) · Skin Neoplasms (1) · Uterine Cervical Dysplasia (1) · Warts (1)
Galderma R&D (7) · Joint Authority for Päijät-Häme Social and Health Care (4) · Photocure (3) · Biofrontera Bioscience GmbH (2) · Maastricht University Medical Center (2) · Bispebjerg Hospital (1) · Centre Dermatologique du Roy (1) · Fundación Dermabase (1) · Galderma Laboratorium GmbH (1) · Innovaderm Research Inc. (1) · Medical University of Vienna (1) · Norwegian University of Science and Technology (1) · Universidad de Antioquia (1) · University Hospital, Ghent (1) · University Hospital, Limoges (1)
Germany (5) · Finland (4) · Australia (3) · Netherlands (3) · Norway (3) · United Kingdom (3) · Belgium (2) · Colombia (2) · Denmark (2) · France (2) · Spain (2) · United States (2) · Austria (1) · Brazil (1) · Canada (1)
Gloria Sanclemente, Dr (2) · Alexandra Geusau, Prof. Dr. (1) · Ann-Marie Wennberg, MD, PhD (1) · Ashish C Bhatia, MD (1) · Barbara Boone, MD PhD (1) · Colin Morton, Dr. (1) · Cyro Festa, md (1) · David Pariser, MD (1) · Hans Christian Wulf, Professor (1) · Hector I Garcia, Dr. (1) · Ida Knutar, Lic. Med. (1) · Janne Rasanen, Lic. Med. (1)
PMID 26011755, PMID 28905294, PMID 29432644, PMID 30329163, PMID 31955461, PMID 34743007, PMID 40934140, PMID 41391634
2014 (1)