Back to resultsSafety Evaluation of Sericin-chitosan Cream in Healthy Volunteers
Primary Purpose
Pressure Sore, Safety Issues
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Sericin and chitosan cream
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Sore
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.
Sites / Locations
- Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sericin and chitosan cream
Cavilon
Arm 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).
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).
Outcomes
Primary Outcome Measures
Skin erythema index
Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Skin melanin index
Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04729556
First Posted
January 25, 2021
Last Updated
January 25, 2021
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT04729556
Brief Title
Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers
Official Title
Safety Evaluation of a Film-forming Cream Containing Sericin and Chitosan for Pressure Sore Treatment in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
June 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Sore, Safety Issues
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sericin and chitosan cream
Arm Type
Experimental
Arm 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).
Arm Title
Cavilon
Arm Type
Active Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
Sericin and chitosan cream
Intervention Description
A novel film-forming cream containing sericin and chitosan
Primary Outcome Measure Information:
Title
Skin erythema index
Description
Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Time Frame
17 days
Title
Skin melanin index
Description
Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Time Frame
17 days
Secondary Outcome Measure Information:
Title
Visual skin irritation
Description
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.
Time Frame
17 days
Title
Self-report topical side effects: rash, edema, vesicles, and itching
Description
Participants will be asked to self-monitor topical side effects: rash, edema, vesicles, and itching (if any), and then inform the investigators.
Time Frame
17 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
City
Bangkok
ZIP/Postal Code
10310
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers
We'll reach out to this number within 24 hrs