Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers
Safety Evaluation of a Film-forming Cream Containing Sericin and Chitosan for Pressure Sore Treatment in Healthy Volunteers
1 other identifier
interventional
112
1 country
1
Brief Summary
A prospective, randomized, active-controlled clinical trial was conducted to evaluate safety of sericin-chitosan cream in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2020
CompletedFirst Submitted
Initial submission to the registry
January 25, 2021
CompletedFirst Posted
Study publicly available on registry
January 28, 2021
CompletedJanuary 28, 2021
January 1, 2021
26 days
January 25, 2021
January 25, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Visual skin irritation
17 days
Self-report topical side effects: rash, edema, vesicles, and itching
17 days
Study Arms (2)
Sericin and chitosan cream
EXPERIMENTALA 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).
Cavilon
ACTIVE COMPARATORActive 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).
Interventions
A novel film-forming cream containing sericin and chitosan
Eligibility Criteria
You may qualify if:
- Healthy volunteers at the age of 20 - 65 years
- voluntarily sign inform consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Bangkok, 10310, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 25, 2021
First Posted
January 28, 2021
Study Start
February 15, 2020
Primary Completion
March 12, 2020
Study Completion
June 25, 2020
Last Updated
January 28, 2021
Record last verified: 2021-01