Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04559165

Enrollment

Registered

2020-09-22

Start date

2020-09-15

Completion date

2021-06-16

Last updated

2020-09-22

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

Conditions

Pressure Ulcer

Brief summary

To evaluate efficacy and safety of sericin and chitosan cream for preventing and limiting the progressive of pressure sore in 20 patients

Interventions

OTHERsericin and chitosan cream

sericin and chitosan cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Age more than 18 years old * 2-digit Stirling Pressure Sore Severity Scale less than or equal to 2.4 * No chitosan, sericin, and dimethicone allergy * Without skin diseases * Without Autoimmune diseases * Willingness to participate

Exclusion criteria

* Have uncontrolled diseases * Have complication or adverse effects during the time of participation * Cannot follow protocol * Pregnancy or lactation * Participate in other study

Design outcomes

Primary

Measure	Time frame	Description
Pressure ulcer scale for healing	21 days	Score 0 to 17, higher scores mean a worse outcome

Secondary

Measure	Time frame	Description
Melanin index	21 days	Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Transepidermal water loss	21 days	Transepidermal water loss index of skin will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy skin.
Moisture index	21 days	Moisture index of skin will be measured using Cutometer (Corneometer). There is no unit. Higher value mean lower risk of unhealthy skin.
Adverse events	21 days	Adverse events will be observed. They will be recorded as present or not present
Erythema index	21 days	Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.

Countries

Thailand

Contacts

Primary ContactPornanong Aramwit, Ph.D

aramwit@gmail.com+66899217255

Outcome results

None listed

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