LESION-DIRECTED TREATMENT (UP TO 10 LESIONS SIMULTANEOUSLY)5 FIELD-DIRECTED TREATMENT (UP TO 25 CM2 ) 5 EFFECTIVE IN BOTH SETTINGS1-5 ACTIKERALL is effective in both settings, lesion (up to 10) or field2-5 • ACTIKERALL once-daily is an effective, topical treatment suitable for both lesion (up to 10) and field (up to 25 cm2 ) that covers a broad range from slightly palpable to moderately thick hyperkeratotic actinic keratoses (grade I/II).2-5 Do not exceed total treatment area of 25cm2 . TARGETS LESIONS AND FIELD ®
Patients with complete clinical clearance of AK lesions in the treatment field 8 weeks post-treatment ACTIKERALL significantly improved complete clinical clearance vs. vehicle2 ACTIKERALL significantly reduced total lesion count and lesion severity in field-directed AK treatment vs. vehicle2 • A greater number of lesions were cleared (from grade I or II to grade 0) with ACTIKERALL vs.vehicle (81.7% vs. 51.0%, respectively) at the end of follow-up (8 weeks post-treatment)2 Lesion evolution in a patient from the study FIELD-DIRECTED STUDY END OF TREATMENT (week 12) 8 WEEKS POST-TREATMENT (week 20) BASELINE 80 70 60 50 40 30 20 10 0 % of patients with complete clinical clearance Cochran-Mantel-Haenszel test adjusting for anatomical site and baseline. Complete clinical clearance: no clinically visible AK lesions in the selected treatment area. ACTIKERALL (n=108) Vehicle (n=55) p=0.0006 18.2 49.5 Adapted from Stockfleth et al, 2016.2 Vehicle: DMSO. ACTIKERALL SHOWED SUPERIOR EFFICACY IN FIELD-DIRECTED AK TREATMENT VS. VEHICLE2 ®
ACTIKERALL significantly reduced the number of subclinical AK lesions vs. vehicle with a reduction difference of 42.4% (p=0.0051)6 Vehicle: DMSO. RCM sub-study with 30 patients of the multicentre, randomised, parallel, double-blind, vehiclecontrolled clinical trial to evaluate the efficacy and tolerability of ACTIKERALL solution in the field-directed treatment of AKs grade I−II on the face, scalp and/or forehead (field cancerisation). Endpoints of the sub-study: change from baseline in subclinical lesion count, complete clearance of three selected subclinical lesions and complete clearance of a single clinical lesion.6 Change from baseline in total number of subclinical lesions assessed by RCM among three pre-selected subclinical lesions 0 -10 -20 -30 -40 -50 -60 -70 -80 -90 -100 Week 4 Week 6 Week 12 8 weeks post- treatment % change in total number of lesions Adapted from Ulrich et al, 2016.6 ACTIKERALL (n=17) Vehicle (n=10) Treatment Follow-up -10.4 -3.9 -66.7 -40.1 -22.9 -22.1 -89.6 -47.1 Treatment comparison: -42.4% p=0.0051 FIELD-DIRECTED STUDY ACTIKERALL SHOWED EFFICACY IN THE TREATMENT OF SUBCLINICAL AK LESIONS IN A SUBSET OF 30 PATIENTS6 ®
® Vehicle: DMSO. Patients with complete clinical clearance 8 weeks post-treatment Complete clinical clearance rates were superior withACTIKERALLvs. the comparators4 ACTIKERALL demonstrated long-term superiority in terms of lesion recurrence rates vs. the comparators3 • At 12 months post-treatment, 85.8% of lesions did not recur in the ACTIKERALL group compared to 79.8% (p=0.044) in the vehicle and 81.0% (p=0.025) in the diclofenac HA groups3 70 60 50 40 30 20 10 0 % of patients with complete clinical clearance Adapted from Stockfleth et al, 2011.4 Complete clinical clearance: no clinically visible AK lesions in the selected treatment area. p<0.001 p<0.001 15.1 32.0 55.4 Vehicle (n=98) ACTIKERALL (n=187) Diclofenac HA (n=185) ACTIKERALL ONCE DAILY IS AN EFFECTIVE LESION AND ALSO FIELD-DIRECTED TREATMENT, INCLUDING MODERATELY THICK HYPERKERATOTIC AK LESIONS2-4
®® Evolution of irritation during treatment DURING TREATMENT (week 4) 8 WEEKS POSTTREATMENT (week 20) BASELINE ACTIKERALL showed a good tolerability profile in both settings, lesion (up to 10 simultaneously) and field2-5 • During treatment, mild to moderate irritation and inflammation at the application site can occur5 ACTIKERALL showed high levels of patient satisfaction2,3 • 94.7% treated with ACTIKERALL in the lesion-directed study would recommend the treatment3 • In the field-directed study, overall treatment satisfaction (TSQM) significantly improved for the ACTIKERALL group vs. vehicle at follow-up (69.2% vs. 56.1%; p=0.0019)2 • Treatment discontinuation rates due to treatment-emergent adverse effects (TEAE) were low (1.9%) in the field-directed study2# #AEs were more common in patients receiving 5-FU/SA (95.2%) compared to diclofenac HA (76.8%) or vehicle (84.7%). Most AEs for 5-FU/SA patients were mild-to-moderate application-site reactions (92%), with irritation and inflammation the most common. Treatment was well tolerated; only seven patients (3.7%) discontinued treatment due to AEs in the 5-FU/SA group versus nine patients (4.9%) receiving diclofenac HA. TOLERABILITY AND CONVENIENCE ACTIKERALL HAS A GOOD TOLERABILITY PROFILE AND IS WELL ACCEPTED BY PATIENTS2-5,7,8
® • ACTIKERALL can target multiple AKs (up to 10 lesions simultaneously) or a continuous field up to 25 cm2 . Do not exceed total treatment area of 25 cm2 at a time5 • ACTIKERALL should be applied once daily until the lesions have completely cleared or for up to a maximum of 12 weeks. Response can be seen as early as 4 weeks5,8 To open the bottle, press the lid down and turn Dab the treatment on the AK lesions or field up to 25 cm2 ACTIKERALL has an integrated brush for precise application3 • ACTIKERALL is applied once-daily until AK lesions have cleared or for up to 12 weeks5 1 3 Remove excess treatment from the brush by wiping it on the neck of the bottle 2 Close the bottle properly 4 ACTIKERALL SIGNIFICANTLY REDUCED AK LESIONS, EVEN DURING SHORT TREATMENT PERIODS, IN ROUTINE CLINICAL PRACTICE8 • It is important that before ACTIKERALL is reapplied, the existing film should be peeled off5 • Warm water may help to remove the film5 CONVENIENT APPLICATION FOR BOTH LESION3-5 AND FIELD2,5
® PRODUCT INFORMATION AND REFERENCES AK = Actinic Keratosis, DSMO = Dimethyl Sulfoxide, RCM = Reflectance Confocal Microscopy, TSQM = Treatment Satisfaction Questionnaire for Medication, AEs = Adverse Events. References 1. ACTIKERALL Approved Product Information. 2. 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). 2016. 3. 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):370-4. 4. Stockfleth E, et al. Low-dose 5-fluorouracil in combination with salicylic acid as a new lesiondirected option to treat topically actinic keratoses: histological and clinical study results. Br J Dermatol. 2011;165(5):1101-8. 5. Summary of Product Characteristics ACTIKERALL. 2016. 6. Ulrich C, 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: sub-set analyses of a Phase III, randomised, vehiclecontrolled trial. Poster P2285. Presented at 25th European Academy of Dermatology and Venereology (EADV) Congress; 28 September - 2 October 2016; Vienna, Austria. 7. 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. 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. Malvehy J, et al. Treatment monitoring of 0.5% 5-fluorouracil and 10% salicylic acid in clinical and subclinical actinic keratoses with the combination of optical coherence tomography and reflectance confocal microscopy. J Eur Acad Dermatol Venereol. 2016;30(2):258-65. 10. Reinhold U, et al. Low-dose 5-fluorouracil in combination with salicylic acid for the treatment of actinic keratoses on the hands and/or forearms - results of a non-interventional study. J Eur Acad Dermatol Venereol. 2016. Please review the Product Information before prescribing. Full Product Information is available from maynepharma.com/actikerall. ▼ 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 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. PBS information: This medicine is not listed on the PBS.
ACTIKERALL is a combination therapy that goes beyond the lesion: • ACTIKERALL has demonstrated efficacy in both settings, lesion and field2-4 • Improved complete clinical clearance and lowered AK recurrence9 ACTIKERALL has a good safety profile and is well-accepted by patients, even on difficult-totreat areas2-5,7,8,10 A COMBINATION THAT GOES BEYOND THE LESION ACTIKERALL® is a registered trademark of Almirall S.A. ACTIKERALL is distributed by Mayne Pharma International Pty Ltd under license from Almirall Hermal GmbH. Mayne Pharma International Pty Ltd. ABN 88 007 870 984. 1538 Main North Road, Salisbury South, SA 5106. Phone: 1300 081 849. maynepharma.com. Date of preparation: June 2021. ACT004. ®