Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers

Not Applicable

Completed

• Conditions: Pressure Sore; Safety Issues
• Interventions: Device: Sericin and chitosan cream

• Registration Number: NCT04729556
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2020-02-15
• Primary Completion: 2020-03-12
• Study Completion: 2020-06-25
• Status Verified: 2021-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Last Update Submitted: 2021-01-25
• Study First Posted: 2021-01-28
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cavilon	Sericin and chitosan cream	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).
Sericin and chitosan cream	Sericin and chitosan cream	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).

Primary Outcome Measures

Name	Time	Method
Skin erythema index	17 days	Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Skin melanin index	17 days	Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.

Secondary Outcome Measures

Name	Time	Method
Visual skin irritation	17 days	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.
Self-report topical side effects: rash, edema, vesicles, and itching	17 days	Participants will be asked to self-monitor topical side effects: rash, edema, vesicles, and itching (if any), and then inform the investigators.

Trial Locations

Locations (1)

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity; 🇹🇭 Bangkok, Thailand