Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers
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| ClinicalTrials.gov Identifier: NCT04729556 |
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Recruitment Status :
Completed
First Posted : January 28, 2021
Last Update Posted : January 28, 2021
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Sponsor:
Chulalongkorn University
Information provided by (Responsible Party):
Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
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Brief Summary:
A prospective, randomized, active-controlled clinical trial was conducted to evaluate safety of sericin-chitosan cream in healthy volunteers.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pressure Sore Safety Issues | Device: Sericin and chitosan cream | Not Applicable |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 112 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Safety Evaluation of a Film-forming Cream Containing Sericin and Chitosan for Pressure Sore Treatment in Healthy Volunteers |
| Actual Study Start Date : | February 15, 2020 |
| Actual Primary Completion Date : | March 12, 2020 |
| Actual Study Completion Date : | June 25, 2020 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Poliglusam
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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).
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Device: Sericin and chitosan cream
A novel film-forming cream containing sericin and chitosan |
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Active Comparator: 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). |
Device: Sericin and chitosan cream
A novel film-forming cream containing sericin and chitosan |
Primary Outcome Measures :
- 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.
- 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 Outcome Measures :
- 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.
- 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.
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| Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729556
Locations
| Thailand | |
| Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity | |
| Bangkok, Thailand, 10310 | |
Sponsors and Collaborators
Chulalongkorn University
| Responsible Party: | Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University |
| ClinicalTrials.gov Identifier: | NCT04729556 |
| Other Study ID Numbers: |
EC 19310-20 |
| First Posted: | January 28, 2021 Key Record Dates |
| Last Update Posted: | January 28, 2021 |
| Last Verified: | January 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Pressure Ulcer Skin Ulcer Skin Diseases Chitosan Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Chelating Agents Sequestering Agents Hemostatics Coagulants |