Treatment of basal cell carcinomas (BCCs) with a combination regimen consisting of ablative fractional laser (AFL) and off-label ingenol mebutate gel is associated with relatively high 90-day histologic cure rates, study research published in the Journal of the European Academy of Dermatology and Venereology suggests.
The study also found that optical coherence tomography (OCT) and reflectance confocal microscopy (RCM) are effective noninvasive methods for detecting subclinical BCCs at 90 days.
Researchers from Germany and Denmark recruited a total of 20 patients with histologically verified superficial (n = 7) and nodular (n = 13) low-risk BCCs treated in Copenhagen, Denmark. The BCCs and surrounding 5-mm margin of normal skin were treated with a combined fractional CO2 laser or ingenol mebutate gel at concentrations of 0.015% or 0.05%. At day 29 and day 90 following the first treatment, the researchers clinically assessed BCC response to the administered treatments. Response was also evaluated histologically at day 90. In addition, local skin reactions were evaluated at all visits.
A total of 18 of 20 patients received a second treatment at day 29, as residual, persistent BCC was clinically detected by OCT or RCM. The use of OCT and RCM detected subclinical BCCs in 25% (n = 5) of cases. The histological cure rate at day 90 was 70% (n = 14), which corresponded to clinical and OCT/RCM cure rates of 65% and 60%, respectively.
There was substantial and significant agreement between assessment methods (k ≥0.796, P <.0001). The clearance rates were similar for lesions treated with ingenol mebutate at both concentrations (P =.141), as well as for superficial and nodular BCCs (P =.354). A majority of patients with clearance had scarring; however, local skin reactions were tolerable.
Limitations of the study included the small sample size, the open-label and uncontrolled design, and the short follow-up period.
The researchers concluded that “OCT and RCM were useful to detect incomplete BCC response and could be important in the introduction of new, explorative treatments” of low-risk BCCs.
Disclosure: This clinical trial was supported by LEO Pharma A/S. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Banzhaf CA, Phothong W, Suku MH, et al. Basal cell carcinoma treated with combined ablative fractional laser and ingenol mebutate – an exploratory study monitored by optical coherence tomography and reflectance confocal microscopy [published online August 23, 2019]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.15907