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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04729556
Other study ID # EC 19310-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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