Topical Channa striatus 5% cream for inflammatory skin conditions: A phase I randomized double-blind, controlled trial

Background: Channa striatus or better known as the haruan fish is an indigenous, snakehead, striped, air breathing freshwater fish of Malaysia and has long been consumed traditionally during post-operative and post-partum period to speed recovery. Most medical properties of the haruan are contributed to its high content of essential fatty and amino acids. This was a phase I clinical trial to examine the safety of Channa striatus (CS) 5% cream with patch testing and cumulative dosing for up to 4 weeks on the healthy skin. Methods: This double-blind randomized controlled trial was conducted in two stages. Eighty-three participants who fulfilled the inclusion criteria underwent patch testing. The allergens, aqueous and CS 5% cream, were patch tested simultaneously but separately on each arm of the same participant. The participants with a negative patch test started stage 2, whereby they applied randomly assigned creams on both forearms for a duration of 1 month. Results: A total of 83 participants were screened successfully and underwent patch testing. One participant in the cohort developed a positive patch test to CS 5% and was excluded from stage 2. Two participants experienced mild side effects that resolved with mild topical steroid. The incidence of allergic contact dermatitis and irritant contact dermatitis was 1.2% and 2.4% in the participants, respectively. Conclusion: The uniquely Malaysian Channa striatus 5% cream has a good safety profile. Information on the safety and tolerability obtained from this study can be used to design larger phase II studies in patients with inflammatory skin conditions. Trial registration: Registered with National Medical Research Register of Malaysia, ID: NMRR-14-1901-22292