Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729556
• Other study ID #: EC 19310-20
• Status: Completed
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: June 25, 2020

Study information

• Verified date: January 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 25, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pressure Sore
• Pressure Ulcer
• Safety Issues

Intervention

Device:
• Sericin and chitosan cream
A novel film-forming cream containing sericin and chitosan

Locations

Country	Name	City	State
Thailand	Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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