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Administration

Convenient application for both lesion and field3-6#

  • ACTIKERALLcan target multiple AKs (up to 10 lesions simultaneously) or a continuous field of up to 25 cm2
  • ACTIKERALLshould be applied once daily until the lesions have completely cleared or for up to a maximum of 12 weeks.Results can be seen as early as 4 weeks3,8,10

Actikerall (1)

 

  •   ACTIKERALL
    • has an integrated brush for precise application1
    • is applied once daily until AK lesions have cleared or for up to 12 weeks1
    • should not be applied to hairy skin as hair gets stuck together in the affected area
    • if needing to apply to hairy skin, a shave or other suitable methods of hair removal should be considered prior to any application

  • Use only on the face, forehead or bald scalp (excluding eyelids, lips and mucosa)
 
#Do not exceed a total treatment area of 25 cm2at a time1
It is important that before ACTIKERALL is reapplied, the existing film should be peeled off.1
Using warm water, mineral oil or rubbing alcohol may help you to remove the film from the previous day’s application.7

Click above to watch the ACTIKERALL product application video
PBS
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.
AK = Actinic Keratosis, DMSO = Dimethyl Sulfoxide, RCM = Reflectance Confocal Microscopy, TSQM = Treatment Satisfaction Questionnaire for Medication, AEs = Adverse Events.
 
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.