Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers

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

Detailed Description
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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).

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

Conditions
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Pressure Sore, Safety Issues

Intervention / Treatment
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* Device: Sericin and chitosan cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sericin and chitosan cream<br>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). | Device: Sericin and chitosan cream<br>* A novel film-forming cream containing sericin and chitosan<br>|
| Active Comparator: Cavilon<br>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). | Device: Sericin and chitosan cream<br>* A novel film-forming cream containing sericin and chitosan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin erythema index | Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction. | 17 days | 
| Skin melanin index | Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction. | 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual skin irritation | Photographs of the contact skin area will be used for evaluating the presences and severity of skin irritation (rash, edema, papules, vesicles, and bullae) by dermatologists. | 17 days | 
| Self-report topical side effects: rash, edema, vesicles, and itching | Participants will be asked to self-monitor topical side effects: rash, edema, vesicles, and itching (if any), and then inform the investigators. | 17 days |