Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers

Chulalongkorn University

Status: Completed

Conditions: Safety Issues; Pressure Sore

Treatments: Device: Sericin and chitosan cream

Study type: Interventional

Funder types: Other

Identifiers

NCT04729556

EC 19310-20

Details and patient eligibility

About

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

Full description

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).

Enrollment: 112 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Sericin and chitosan cream

Experimental group

Description:

A flim-forming cream containing sericin and chitosan cream. Apply sericin and chitosan cream on the back area of healthy volunteers and cover with self-adhesive nonwoven fabric in induction phase I (72 hours), induction phase II (72 hours), and challenge phase (72 hours).

Treatment:

Device: Sericin and chitosan cream

Cavilon

Active Comparator group

Description:

Active control is a commercial cream containing dimethicone as the substance forms a durable, thin, and transparent film. The cream is used as a moisturizer to prevent the skin against irritation, dryness, and pressure ulcers. Apply sericin and chitosan cream on the back area of healthy volunteers and cover with self-adhesive nonwoven fabric in induction phase I (72 hours), induction phase II (72 hours), and challenge phase (72 hours).

Treatment:

Device: Sericin and chitosan cream