Efficacy and Safety of Topical Lignosus rhinocerus TM02® Extract (xLr®) Versus 1% Hydrocortisone Cream in Mild-to-moderate Atopic Dermatitis. A 6-week Split-site Pilot Study

Background: Lignosus rhinocerus (commonly known as tiger milk mushroom) is an edible mushroom indigenous to the jungles of Asia, including Malaysia, which has anti-inflammatory, immunomodulatory, antifungal and antibacterial properties. Aims: This study aimed to evaluate the efficacy and safety of a topical cream containing L. rhinocerus TM02 ® extract (xLr ® ) versus 1% hydrocortisone cream as a treatment for mild-to-moderate atopic dermatitis (AD). Subjects and Methods: We investigated the use of L. rhinoceros as a topical treatment option for AD by carrying out a 6-week, open-label, split-site study involving 22 patients aged ≥ 12 years. Disease severity was assessed using the Peak Pruritus Numerical Rating Scale (PNRS) and the AD Severity Index (ADSI). The occurrence of any adverse events was recorded. Results: The study cream containing xLr ® showed a significant improvement in severity (mean ADSI 4.4 ± 2.7 at baseline to 2.1 ± 2.0 at Week 6, P = 0.010) and pruritus (mean PNRS 2.2 ± 2.2 at baseline to 1.1 ± 1.5 at Week 6, P = 0.018). These results at 6 weeks were comparable to the hydrocortisone 1% cream arm, with a reduction in mean ADSI from 4.3 ± 2.3 at baseline to 1.9 ± 2.0 ( P < 0.010) and mean PNRS from 2.3 ± 2.1 to 0.8 ± 0.8 ( P = 0.002). There was no statistical difference between the ADSI ( P = 0.445) and PNRS ( P = 0.133) of xLR ® and hydrocortisone 1% cream at the end of Week 6. No adverse events were reported. Conclusion: xLr® is a non-steroidal topical agent with comparable efficacy to 1% hydrocortisone with a potential utility in the treatment armamentarium for AD.