To view the content, please enter your AHPRA Number:

This step is required by Medicines Australia.
Mayne Pharma do not record your AHPRA details.

The content of this webpage is for Australian healthcare professionals only.

Efficacy

 

Lesion and field-directed studies#

ACTIKERALL once daily is an effective lesion and also field-directed treatment, including moderately thick hyperkeratotic AK lesions1,3-6#

#<25cm2

ACTIKERALL is a highly effective lesion-directed treatment for AKs4-6#
Complete clinical clearance rates were superior with ACTIKERALL vs. the comparators4-6
#<25cm2
 Actikerall table 2

 Vehicle: DMSO.

Diclofenac HA (diclofenac 3% in hyaluronic acid)

ACTIKERALL showed superior efficacy in field-directed AK treatment vs. vehicle5#
 
ACTIKERALL resulted in complete clinical clearance in significantly more patients than vehicle5
 
 
efficacy table 1

Vehicle: DMSO

Efficacy table 3

Pictures courtesy of Almirall S.A.
 
Actikerall® significantly reduced total lesion count and lesion severity in field-directed AK treatment vs. vehicle5#
A
greater number of lesions were graded 0 with Actikerall
® vs. vehicle (
81.7%vs.
51.0%, respectively) at the
end of follow-up (8 weeks post-treatment)
5
 
 
#<25cm2
ACTIKERALL showed efficacy in the treatment of subclinical AK lesions in a subset of 30 patients9
ACTIKERALL significantly reduced the number of subclinical AK lesions vs. vehicle with a reduction difference of ∼ 42% p=0.00519
 
 Efficacy table 4

 

Vehicle: DMSO.

RCM sub-study with 30 patients of the multicentre, randomised, parallel, double-blind, vehicle controlled 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: percentage change from baseline in subclinical lesion count, and complete clearance of three selected subclinical lesions9
ACTIKERALL: Early clinical response to 5-fluorouracil 0.5% and salicylic acid 10% topical solution in the treatment of actinic keratoses of the head10
ACTIKERALL results can be observed from week 4
 
At week 4, complete clearance of 50% of the treated lesions and a partial clearance of 28% (Fig. 1)
 

Figure 1.Treatment Effectiveness of ACTIKERALL on Face and Scalp Actinic Keratosis

Figure 2.Actinic keratosis area and severity index (AKASI) mean score variations in the global population along the treatment period

 
Figure 3.Clinical comparison between images before (A,C) and after the end of the treatment (B,D) in a patient with grade 2 actinic keratosis of the ear

 

Pictures from Garofalo V,et al2022

                                                   

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 At4 weeksof single-day application, complete clearance in 50% of the lesions (Fig. 1)

 At 12 weeks, the Actinic Keratosis Area and Severity Index (AKASI) score decreased from 3.3 to a final score of 0.9 (Fig .2)

 At 12 weeks: 84% complete clearance, 8% with partial clearance (Fig. 1, 3)

 Follow-up showed the maintenance of the results over time, and also after the end of the treatment

In some patients, treatment could be stopped earlier due to a satisfactory clinical result.

Study objective: Observational, prospective clinical study to assess the short-term treatment effectiveness of 5-fluorouracil and salicylic acid on face and scalp actinic keratoses of grade 1 and 2 in 40 patients10

 

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.