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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04729556

Enrollment

112

Registered

2021-01-28

Start date

2020-02-15

Completion date

2020-06-25

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Sore, Safety Issues

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).

Interventions

DEVICESericin and chitosan cream

A novel film-forming cream containing sericin and chitosan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Skin erythema index	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	17 days	Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.

Secondary

Measure	Time frame	Description
Visual skin irritation	17 days	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	17 days	Participants will be asked to self-monitor topical side effects: rash, edema, vesicles, and itching (if any), and then inform the investigators.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026