Journal of Clinical and Aesthetic Dermatology

DEC 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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25 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY December 2017 • Volume 10 • Number 12 O R I G I N A L R E S E A R C H decreased, approaching baseline scores by approximately Week 4. It is always important that proper patient education is provided regarding expected skin reactions and their management when treating patients with AK—particularly those without prior experience of topical treatment. Approximately 80 to 90 percent of patients on topical therapy will experience LSRs such as erythema, dryness, burning, and pruritus. 18 Thus, providing clear information (including photographs to support communication) can help to alleviate fear, and patients can also be provided with techniques to use at home to help reduce any pain or itching. Less than 5 percent of patients in each treatment group had severe AEs. Treatment- related AEs were reported in 50.8, 69.8, and 66.1 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively; approximately half of the patients had application site pain and approximately one- third had application site pruritus. Based upon these findings, the safety of the dosing regimen with once-daily dosing for three consecutive days was in line with previous dose finding trials evaluating ingenol disoxate two-day regimens. 13,14 Efficacy. The three-day treatment regimen evaluated in this trial demonstrated clinically relevant efficacy. This was demonstrated both by the high percentage reduction in AK lesion count from baseline and also the percentage of patients who achieved complete clearance (AKCLEAR 100) by the end of the trial at Week 8. It should also be noted that approximately two-thirds of patients in the face/chest and scalp groups and half of the patients in the trunk/extremities group achieved partial clearance (AKCLEAR 75) by Week 8. Comparable levels were observed for reduction in AK lesion count, as well as partial and complete clearance at Week 4, indicating that the majority of the effect on AK lesions was already achieved by this time point. Similar findings have been reported using ingenol disoxate daily dosing for two consecutive days. Weiss et al 13 observed a 72.7-percent reduction in AK lesion count from baseline to Week 8 when ingenol disoxate was administered at 0.037% on the scalp; the majority of this effect was reached by Week 4. Similarly, Bourcier et al 14 reported a 79.0-percent reduction in AK lesion count from baseline at Week 8 when ingenol disoxate 0.018% gel was administered on the face/chest. Weiss et al 13 reported that when patients were treated with ingenol disoxate 0.037% gel on the scalp, 21.9 percent of patients achieved complete clearance, while 54.7 percent achieved partial clearance at Week 8. In the Bourcier et al trial, 14 when treated with ingenol disoxate 0.018% gel on the face/chest, 24.2 percent of patients achieved complete clearance and 62.9 percent achieved partial clearance at Week 8. The rate of complete and partial clearance, at the same concentrations of ingenol disoxate as used in previous trials, was increased in the present trial, which is likely due to the additional treatment day. The efficacy of ingenol disoxate in hyperkeratotic/hypertrophic lesions was also demonstrated by a percentage reduction in AK lesion count, although this was slightly less than that observed in the nonhyperkeratotic/ hypertrophic AK lesions. However, due to the small number of patients with this subtype of AK lesions and also the low number of lesions per patient, the CIs for the estimated mean percent reduction were wide. Approximately half of patients in the face/chest and scalp groups and a quarter of patients in the trunk/ extremities group demonstrated complete clearance of hyperkeratotic/hypertrophic lesions. These data suggest that ingenol disoxate might be effective on these lesions, which are notoriously difficult to treat. It is important to note that a field therapy that is highly effective at eliminating clinically visible lesions, as demonstrated in the reduction of AK lesion count and clearance rates, is also likely to eliminate subclinical lesions that are not visible. 19 Treatment regimen and dose concentration. This trial evaluated the safety and efficacy of ingenol disoxate gel at different concentrations on different anatomical locations when applied once daily for three consecutive days. The same treatment regimen (once daily for three consecutive days) has proved effective with ingenol mebutate when 0.015% of such was applied to the face or scalp (25cm 2 ). 10 Although complete clearance was slightly lower in the present trial, it is important to note that the treatment area was up to 10 times larger with a greater number of baseline AK lesions, making complete clearance more difficult to achieve. A more appropriate comparison for trials in which treatment area sizes are different is percentage reduction in AK lesion count; in FIGURE 7. Percentage of patients with AKCLEAR 75 at Weeks 4 and 8; excludes hyperkeratotic/hypertrophic lesions AKCLEAR 75: partial clearance of actinic keratoses defined as 75 percent reduction or more in baseline AK lesion count

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