Safety Evaluation of a Film-forming Cream Containing Sericin and Chitosan for Pressure Sore Treatment in Healthy Volunteers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pressure Sore
- Sponsor
- Chulalongkorn University
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Skin erythema index
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Skin erythema index
Time Frame: 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
Time Frame: 17 days
Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Secondary Outcomes
- Visual skin irritation(17 days)
- Self-report topical side effects: rash, edema, vesicles, and itching(17 days)