Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-15

Study Completion Date

2020-06-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A prospective, randomized, active-controlled clinical trial was conducted to evaluate safety of sericin-chitosan cream in healthy volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Chitosan Dressings to Facilitate Safe Effective Debridement of Chronic Wounds & Minimize Wound Bacterial Re-colonization

NCT01035944

Wound Debridement

TERMINATED NA

Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

NCT02224638

Pressure Ulcers

COMPLETED PHASE4

Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment

NCT04743375

Wound Heal Wound Surgical Donor Site Complication

UNKNOWN NA

Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel

NCT01895933

Wound Healing

COMPLETED NA

Nonsilicone Gel Sheet for Burn Hypertrophic Scars

NCT05429411

Burn Scar

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pressure Sore Safety Issues

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sericin and chitosan cream

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).

Group Type EXPERIMENTAL

Sericin and chitosan cream

Intervention Type DEVICE

A novel film-forming cream containing sericin and chitosan

Cavilon

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).

Group Type ACTIVE_COMPARATOR

Sericin and chitosan cream

Intervention Type DEVICE

A novel film-forming cream containing sericin and chitosan

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sericin and chitosan cream

A novel film-forming cream containing sericin and chitosan

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes