The content of this webpage is for Australian healthcare professionals only.
Resources
ACTIKERALL application video
Educational webinar on Actinic Keratosis and treatments
Presented by Dr Ryan De Cruz, MBBS (Hons) BMedSci FACD
Please review the Product Information before prescribing.
▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at
www.tga.gov.au/reporting-problems.
| WARNING - Actikerall® should only be used on a total area no greater than 25 cm2 at a time. Use should be limited to certain body sites and skin types. See PI section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. |
References
1. ACTIKERALL Product Information. 2. Rajkumar JR, et al. INDIVIDUAL ARTICLE: Safety and Tolerability of Topical Agents for Actinic Keratosis: A Systematic Review of Phase 3 Clinical Trials. J Drugs Dermatol. 2021;20;10(Suppl):s4-14. 3. Simon JC, et al. A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis. J Eur Acad Dermatol Venereol. 2015;29(5):881-9. 4. Stockfleth E, et al. Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratoses: histological and clinical study results. Br J Dermatol. 2011;165(5):1101-8. 5. Stockfleth E, et al. Efficacy and Safety of 5-Fluorouracil 0.5%/Salicylic Acid 10% in the Field-directed Treatment of Actinic Keratosis: a Phase III, Randomized, Double-blind, Vehicle-controlled Trial. Dermatol Ther (Heidelb). 2017;7(1):81-96. 6. Stockfleth E, et al. Recurrence rates and patient assessed outcomes of 0.5% 5-fluorouracil in combination with salicylic acid treating actinic keratoses. Eur J Dermatol. 2012;22(3):370-374. 7. Martínez N, et al. Alternative lacquer removal techniques to remove 0.5% 5-fluorouracil/10% salicylic acid topical solutions for actinic keratosis. Presented at 14th EADO Congress; 6-9 November; Barcelona, Spain. 2018. 8. Szeimies RM, et al. Efficacy of low-dose 5-fluorouracil/salicylic acid in actinic keratoses in relation to treatment duration. J Dtsch Dermatol Ges. 2015;13(5):430-8. 9. Ulrich M, et al. Use of reflectance confocal microscopy to evaluate 5-fluorouracil 0.5%/salicylic acid 10% in the field-directed treatment of subclinical lesions of actinic keratosis: subanalysis of a Phase III, randomized, double-blind, vehicle-controlled trial. J Eur Acad Dermatol Venereol. 2018;32(3):390-396. 10. Garofalo V, et al. Early clinical response to 5-fluorouracil 0.5% and salicylic acid 10% topical solution in the treatment of actinic keratoses of the head: an observational study. J Dermatolog Treat. 2022;33(5):2664-2669.
