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Completed

NCT Number: NCT04729556

Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers

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

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Key information

Conditions

Pressure Sore Pressure Ulcer Safety Issues Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity

Bangkok, 10310, Thailand

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sericin and chitosan cream

Device

A novel film-forming cream containing sericin and chitosan

Primary outcomes

  1. Skin erythema index

    Time frame: 17 days

    Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.

  2. Skin melanin index

    Time frame: 17 days

    Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.

Secondary outcomes

  1. Visual skin irritation

    Time frame: 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.

  2. Self-report topical side effects: rash, edema, vesicles, and itching

    Time frame: 17 days

    Participants will be asked to self-monitor topical side effects: rash, edema, vesicles, and itching (if any), and then inform the investigators.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Safety Evaluation of a Film-forming Cream Containing Sericin and Chitosan for Pressure Sore Treatment in Healthy Volunteers

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2021
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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