Topical Methyl Aminolevulinate
Abstract
Methyl aminolevulinate (MAL), an ester of aminolevulinic acid, has been used effectively as a topical photosensitizing agent in the photodynamic therapy (PDT) of epidermal lesions such as actinic keratosis (AK) and basal cell carcinoma (BCC). The optimal regimen for MAL-PDT (as used in all clinical trials) is MAL 160 mg/g applied for 3 hours before illumination with red light (570-670 nm) at a total light dose of 75 J/cm(2), as determined in dose-finding trials. In randomized, multicenter, phase III clinical trials, treatment with MAL-PDT resulted in a complete response (i.e. complete disappearance) in up to 91% of AK lesions and up to 97% of BCC lesions. With regard to lesion response rates, MAL-PDT was superior to placebo-PDT (in AK or BCC), and at least as effective as cryotherapy (in AK or BCC) or excision surgery (in BCC). Cosmetic outcome with MAL-PDT was excellent to good in the vast majority of patients, and was judged by investigators to be better than with cryotherapy (in AK or BCC) or surgery (in BCC). black triangle Over 75% of BCC lesions treated with MAL-PDT, including difficult-to-treat BCC, were still in remission 12-24 months after the last treatment. MAL-PDT was generally well tolerated in clinical trials. The most frequently reported adverse events were local phototoxicity reactions, most of which were of mild to moderate intensity, resolved rapidly and were rarely treatment limiting.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
FDA approved PDT with 160 mg/g MAL cream (Metvixia) applied 3 h before red light illumination for thin and moderately thick AK lesions in 2004.
“Based on these clinical trials, in 2004, the FDA approved PDT with 160 mg/g MAL cream (Metvixia) applied 3 h before red light (centered at ~630 nm) illumination for both thin and moderately thick AK lesions.”
From 5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy (2023) · cites this paper as [21]
PDT with 160 mg/g MAL and red light showed up to 91% and 97% complete responses in AK and BCC lesions, respectively, in randomized multicenter phase III clinical trials.
“PDT with this MAL protocol and red light illumination (with deeper tissue penetration than blue light) showed up to 91% and 97% complete responses in AK and BCC lesions, respectively, in randomized multicenter phase III clinical trials [21].”
From 5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy (2023) · cites this paper as [21]
MAL-PDT is at least equally effective as cryotherapy or excision surgery for AK and BCC, with better cosmetic outcome.
“This response rate renders MAL-PDT at least equally effective as cryotherapy or excision surgery, two conventional therapies for AK and BCC. The cosmetic outcome with MAL-PDT is better than with the latter two.”
From 5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy (2023) · cites this paper as [21]
Cites
Gomer, C. J. (1988) · Cited by 4,169 · see citing works
The Epidemiology of Skin Cancer
Gloster, H. M., & Brodland, D. G. (1996) · Dermatologic Surgery · doi:10.1111/j.1524-4725.1996.tb00312.x · Cited by 1,262 · see citing works
Nonmelanoma skin cancer in the United States: Incidence
Miller, D. L., & Weinstock, M. A. (1994) · Journal of the American Academy of Dermatology · doi:10.1016/s0190-9622(08)81509-5 · Cited by 1,118 · see citing works
Epidemiology of actinic keratoses and squamous cell carcinoma
Salasche, S. J. (2000) · Journal of the American Academy of Dermatology · doi:10.1067/mjd.2000.103342 · Cited by 534 · see citing works
Photodynamic therapy in dermatology
Kalka, K., Merk, H. F., & Mukhtar, H. (2000) · Journal of the American Academy of Dermatology · doi:10.1016/s0190-9622(00)90209-3 · Cited by 515 · see citing works
Szeimies, R. (2002) · Journal of the American Academy of Dermatology · doi:10.1016/s0190-9622(02)00056-7 · Cited by 434 · see citing works
Wong, C. S. M., Strange, R. C., & Lear, J. T. (2003) · BMJ · doi:10.1136/bmj.327.7418.794 · Cited by 396 · see citing works
A Systematic Review of Treatment Modalities for Primary Basal Cell Carcinomas
Thissen, M. R. T. M., NEUMANN, M. H. A. M., & Schouten, L. J. (1999) · Archives of Dermatology · doi:10.1001/archderm.135.10.1177 · Cited by 385 · see citing works
Photodynamic Therapy Using Topical Methyl Aminolevulinate vs Surgeryfor Nodular Basal Cell Carcinoma
Rhodes, L. E., de Rie, M. A., Enström, Y., Groves, R. W., Morken, T., Goulden, V., Wong, G. A. E., Grob, J., Varma, S., & Wolf, P. (2004) · Archives of Dermatology · doi:10.1001/archderm.140.1.17 · Cited by 356 · see citing works
Pariser, D. M., Lowe, N. J., Stewart, D. M., Jarratt, M. T., Lucky, A. W., Pariser, R. J., & Yamauchi, P. S. (2003) · Journal of the American Academy of Dermatology · doi:10.1067/mjd.2003.49 · Cited by 302 · see citing works
Freeman, M., Vinciullo, C., Francis, D., Spelman, L., Nguyen, R., Fergin, P., Thai, K., Murrell, D., Weightman, W., Anderson, C., et al. (2003) · Journal of Dermatological Treatment · doi:10.1080/09546630310012118 · Cited by 285 · see citing works
Epidemiology of solar keratoses
Frost, C., & Green, A. C. (2006) · British Journal of Dermatology · doi:10.1111/j.1365-2133.1994.tb08544.x · Cited by 259 · see citing works
Use of 5-aminolevulinic acid esters to improve photodynamic therapy on cells in culture.
Gaullier, J., Berg, K., Peng, Q., Anholt, H., Selbo, P. K., Ma, L. W., & Moan, J. E. (1997) · PubMed · Cited by 257 · see citing works
Soler, A., Warloe, T., Berner, A., & Giercksky, K. E. (2001) · British Journal of Dermatology · doi:10.1046/j.1365-2133.2001.04407.x · Cited by 224 · see citing works
Peng, Q., Soler, A. M., Warloe, T., Nesland, J. M., & Giercksky, K.-E. (2001) · Journal of Photochemistry and Photobiology B: Biology · doi:10.1016/s1011-1344(01)00173-7 · Cited by 218 · see citing works
Horn, M., Wolf, P., Wulf, H. C., Warloe, T., Fritsch, C., Rhodes, L. E., Kaufmann, R., de Rie, M. A., Legat, F. J., Stender, I., et al. (2003) · British Journal of Dermatology · doi:10.1111/j.1365-2133.2003.05600.x · Cited by 202 · see citing works
Frequency of pre‐existing actinic keratosis in cutaneous squamous cell carcinoma
Mittelbronn, M. A., Mullins, D. L., Ramos‐Caro, F. A., & Flowers, F. P. (1998) · International Journal of Dermatology · doi:10.1046/j.1365-4362.1998.00467.x · Cited by 196 · see citing works
Fritsch, C., Homey, B., Stahl, W., Lehmann, P., Ruzicka, T., & Sies, H. (1998) · Photochemistry and Photobiology · doi:10.1111/j.1751-1097.1998.tb02492.x · Cited by 192 · see citing works
Rud, E., Gederaas, O. A., Høgset, A., & Berg, K. (2000) · Photochemistry and Photobiology · doi:10.1562/0031-8655(2000)0710640aabnaa2.0.co2 · Cited by 170 · see citing works
McCaughan, J. S. (1999) · Drugs & Aging · doi:10.2165/00002512-199915010-00005 · Cited by 158 · see citing works
The emerging epidemic of skin cancer
Ko, C., Walton, S., Keczkes, K., BURY, H. P. R., & NICHOLSON, C. (1994) · British Journal of Dermatology · doi:10.1111/j.1365-2133.1994.tb02920.x · Cited by 145 · see citing works
Wiegell, S. R. (2003) · Archives of Dermatology · doi:10.1001/archderm.139.9.1173 · Cited by 142 · see citing works
Goldberg, L. H. (1996) · The Lancet · doi:10.1016/s0140-6736(96)91208-8 · Cited by 112 · see citing works
Topical photodynamic therapy in dermatology
Szeimies, R., Calzavara‐Pinton, P., Karrer, S., Ortel, B. J., & Landthaler, M. (1996) · Journal of Photochemistry and Photobiology B Biology · doi:10.1016/s1011-1344(96)07375-7 · Cited by 106 · see citing works
KUIJPERS, D. I. M., Thissen, M. R. T. M., & NEUMANN, M. H. A. M. (2002) · American Journal of Clinical Dermatology · doi:10.2165/00128071-200203040-00003 · Cited by 100 · see citing works
Casas, A. G., Fukuda, H., Venosa, G. M. D., & Batlle, A. M. D. C. (2001) · British Journal of Cancer · doi:10.1054/bjoc.2001.1875 · Cited by 91 · see citing works
Jeffes, E. W. B., & Tang, E. H.-H. (2000) · American Journal of Clinical Dermatology · doi:10.2165/00128071-200001030-00004 · Cited by 80 · see citing works
Topical Aminolevulinic Acid HCl Photodynamic Therapy
Ormrod, D., & Jarvis, B. (2000) · American Journal of Clinical Dermatology · doi:10.2165/00128071-200001020-00009 · Cited by 79 · see citing works
Pharmacology of protoporphyrin IX in nude mice after application of ALA and ALA esters
Moan, J. E., Ma, L., Juzeniene, A., Iani, V., Juzenas, P., Apricena, F., & Peng, Q. (2002) · International Journal of Cancer · doi:10.1002/ijc.10802 · Cited by 75 · see citing works
Stables, G. I., & Ash, D. (1995) · Cancer Treatment Reviews · doi:10.1016/0305-7372(95)90035-7 · Cited by 66 · see citing works
Meng, J.-Y., Kataoka, H., Itoh, H., & Koono, M. (2001) · International Journal of Cancer · doi:10.1002/1097-0215(200102)9999:9999 · Cited by 64 · see citing works
Gederaas, O. A., Holroyd, A., Brown, S. B., Vernon, D. I., Moan, J. E., & Berg, K. (2001) · Photochemistry and Photobiology · doi:10.1562/0031-8655(2001)0730164aameto2.0.co2 · Cited by 62 · see citing works
The advantages of aminolevulinic acid photodynamic therapy in dermatology
Taylor, E. G., & Brown, S. (2002) · Journal of Dermatological Treatment · doi:10.1080/095466302317414645 · Cited by 52 · see citing works
Sharfaei, S., Juzenas, P., Moan, J. E., & Bissonnette, R. (2002) · Archives of Dermatological Research · doi:10.1007/s00403-002-0320-4 · Cited by 51 · see citing works
Juzenas, P., Sharfaei, S., Moan, J. E., & Bissonnette, R. (2002) · Journal of Photochemistry and Photobiology B Biology · doi:10.1016/s1011-1344(02)00269-5 · Cited by 42 · see citing works
Arca, E., Taştan, H. B., Akar, A., Kurumlu, Z., & Gur, A. (2002) · Journal of Dermatological Treatment · doi:10.1080/09546630252775171 · Cited by 41 · see citing works
Chamberlain, A. J., & Kurwa, H. A. (2003) · American Journal of Clinical Dermatology · doi:10.2165/00128071-200304030-00001 · Cited by 14 · see citing works
Tope, W. D., Menter, A., el‐Azhary, R. A., & Lowe, N. J. (2004) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2003.10.419 · Cited by 4 · see citing works
Gebauer, K., Quirk, C., De’Ambrosis, B., & Amies, M. (2004) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2003.10.423 · Cited by 3 · see citing works
Photodynamic therapy using methyl aminolevulinate in patients with basal cell carcinoma
Viniciullo, C., Elliott, T., Gebauer, K., & Spelman, L. J. (2004) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2003.10.420 · Cited by 2 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Basal Cell and Squamous Cell Skin Cancers
Miller, S. J., Alam, M., Andersen, J., Berg, D., Bichakjian, C. K., Bowen, G. M., Cheney, R. T., Glass, L. F., Grekin, R. C., Kessinger, A., et al. (2010) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2010.0062 · Cited by 176 · see citing works
Kaufmann, R., Spelman, L. J., Weightman, W., REIFENBERGER, J., Szeimies, R., Verhaeghe, E., Kerrouche, N., Sorba, V., Villemagne, H., & Rhodes, L. E. (2008) · British Journal of Dermatology · doi:10.1111/j.1365-2133.2008.08488.x · Cited by 145 · see citing works
Wennberg, A.-M., Stenquist, B., Stockfleth, E., Keohane, S., Lear, J. T., Jemec, G., Mork, C., Christensen, E., Kapp, A., Solvsten, H., et al. (2008) · Transplantation · doi:10.1097/tp.0b013e318180731e · Cited by 112 · see citing works
Raspagliesi, F., Fontanelli, R., Rossi, G., Ditto, A., Solima, E., Hanozet, F., & D, S. K. M. (2006) · Gynecologic Oncology · doi:10.1016/j.ygyno.2006.04.009 · Cited by 83 · see citing works
Szeimies, R., Stockfleth, E., Popp, G., Borrosch, F., Brüning, H., Dominicus, R., Mensing, H., Reinhold, U., Reich, K., Moor, A. C. E., et al. (2009) · British Journal of Dermatology · doi:10.1111/j.1365-2133.2009.09377.x · Cited by 73 · see citing works
Christiansen, K., Bjerring, P., & Troilius, A. (2007) · Lasers in Surgery and Medicine · doi:10.1002/lsm.20488 · Cited by 64 · see citing works
Lee, D. A., & Miller, S. J. (2009) · Facial Plastic Surgery Clinics of North America · doi:10.1016/j.fsc.2009.04.004 · Cited by 54 · see citing works
A clinical review of PDT for cutaneous malignancies
Allison, R. R., Sibata, C. H., Downie, G., & Cuenca, R. E. (2006) · Photodiagnosis and Photodynamic Therapy · doi:10.1016/j.pdpdt.2006.05.002 · Cited by 54 · see citing works
Terapia fotodinámica en dermatología
Gilaberte, Y., Serra-Guillén, C., Heras, M. A. E. D. L., Ruiz-Rodríguez, R., Fernández-Lorente, M., Benvenuto-Andrade, C., González-Rodríguez, S., & Guillen-Barona, C. (2006) · Actas Dermo-Sifiliográficas · doi:10.1016/s0001-7310(06)73359-2 · Cited by 47 · see citing works
Current Basal and Squamous Cell Skin Cancer Management
Mendez, B. M., & Thornton, J. F. (2018) · Plastic & Reconstructive Surgery · doi:10.1097/prs.0000000000004696 · Cited by 47 · see citing works
Efficacy and safety of topical ALA-PDT in the treatment of EMPD
Gao, Y., Zhang, X., Wang, W., Yang, Y., Wang, H., Lu, Y., & Fan, D. (2014) · Photodiagnosis and Photodynamic Therapy · doi:10.1016/j.pdpdt.2014.11.004 · Cited by 47 · see citing works
5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy
Howley, R., Chandratre, S., & Chen, B. (2023) · Bioengineering · doi:10.3390/bioengineering10040496 · Cited by 33 · see citing works
Boiy, A., Roelandts, R., & de Witte, P. A. M. (2010) · Journal of Photochemistry and Photobiology B Biology · doi:10.1016/j.jphotobiol.2010.09.012 · Cited by 26 · see citing works
Neves, D. R., Ramos, D. G., Magalhães, G. M., Rodrigues, R. D. C., & de Souza, J. B. A. (2010) · Anais Brasileiros de Dermatologia · doi:10.1590/s0365-05962010000400019 · Cited by 10 · see citing works
El valor terapéutico y clínico de la terapia fotodinámica
Barona, C. G. (2006) · Piel · doi:10.1016/s0213-9251(06)72500-x
Image-Guided Photodynamic Cancer Therapy
Lu, Z., & Vaidya, A. (2009) · Springer eBooks · doi:10.1007/978-1-4419-0131-6_18
Neves, D. R., Ramos, D. G., Magalhães, G. M., & Rodrigues, R. D. C. (2010)
Antineoplastic and Immunomodulating Agents (L)
Kleemann, A. (2017) · Ullmann's Encyclopedia of Industrial Chemistry · doi:10.1002/14356007.a05_001.pub3
Goldberg, D. J., & Chua, E. (2008) · doi:10.1002/9780470696347.ch27
Antineoplastic and Immunomodulating Agents (L)
Kleemann, A. (2022) · Ullmann's Encyclopedia of Industrial Chemistry · doi:10.1002/14356007.a05_001.pub4
Topical methyl aminolevulinate: profile report
&NA; (2004) · Drugs & Therapy Perspectives · doi:10.2165/00042310-200420110-00002
ALA-PDT in the Treatment of Skin Aging
Wang, P., Yu, Y. H., Yang, Y., Wang, B., & Wang, X. (2025) · Springer eBooks · doi:10.1007/978-981-96-8915-6_10
Methyl Aminolevulinate: Photorejuvenation
Ruiz-Rodríguez, R., & Zelickson, B. D. (2011) · Springer eBooks · doi:10.1007/978-1-4419-1298-5_8
- Authors
- Siddiqui, M. A. A., Perry, C. M., & Scott, L. J.
- Corresponding author
- Siddiqui, M Asif A
- Venue
- American Journal of Clinical Dermatology
- Published
- 2004
- Volume
- 5
- Issue
- 2
- Pages
- 127-137
- ISSN
- 1175-0561 (ISSN-L)
- OpenAlex
- W1978239236
- Cited by
- 24
- References
- 41
- Citations by year
- 2025: 1 · 2023: 1 · 2022: 1 · 2018: 1 · 2017: 1 · 2014: 1
- FWCI
- 1.58
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Clinical Dermatology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Nonmelanoma Skin Cancer Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Photodynamic Therapy Research Studies
- Health Sciences › Medicine › Dermatology › Skin Protection and Aging
- Keywords
- methyl aminolevulinate, photodynamic therapy, actinic keratosis, basal cell carcinoma, topical photosensitizer, red light irradiation, treatment response, cosmetic outcome, long-term remission, phototoxicity
- MeSH terms
- Administration, Cutaneous, Aminolevulinic Acid, Basal Cell Carcinoma, Humans, Keratosis, Photochemotherapy, Skin Neoplasms, Photosensitizing Agents
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
