Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers

Safety Evaluation of a Film-forming Cream Containing Sericin and Chitosan for Pressure Sore Treatment in Healthy Volunteers

A prospective, randomized, active-controlled clinical trial was conducted to evaluate safety of sericin-chitosan cream in healthy volunteers.

A prospective, randomized, active-controlled clinical trial was conducted to initially evaluate safety of sericin-chitosan cream in comparison with a commercially available cream containing dimethicone for pressure sore treatment in healthy volunteers. The results of this study provided preliminary safety profile of sericin-chitosan cream before conducting the further clinical trial in specific population (pateints with early-stage pressure sore).

Inclusion Criteria:

• Healthy volunteers at the age of 20 - 65 years
• voluntarily sign inform consent

Exclusion Criteria:

• Diagnosed with chronic skin conditions (e g. eczema and psoriasis) and immunocompromised diseases
• Allergic to silk sericin and chitosan, and dimethicone
• Received immunosuppressive therapy, antihistamine, and corticosteroid drugs two weeks before study enrollment.