Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

Not Applicable

Not yet recruiting

• Conditions: Safety Issues
• Interventions: Other: cream containing 5%sericin and 2%turmeric; Other: cream containing 2.5% sericin and 2%turmeric; Other: cream base; Other: cream containing 10%sericin and 2%turmeric

• Registration Number: NCT05869357
• Lead Sponsor: Chulalongkorn University

Brief Summary

The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers.

Detailed Description

There are 106 healthy volunteers in this study. Upper left arm is divided into 2 parts (2x2 cm) which are A and B area. Upper right arm is divided into 2 parts (2x2 cm) which are C and D area. Four area (A, B, C, and D) are randomized to receive cream containing 2.5% sericin and 2%turmeric, cream containing 5%sericin and 2%turmeric, cream containing 10%sericin and 2%turmeric, and cream base (Control group). Samples are applied 2 times/day for 6 days (Induction phase). Then, the volunteers will stop applying samples for 7 to 10 days (Free period). After that, Samples are applied 2 times/day for 3 days (Challenge phase). Erythema, melanin, humidity, transepidermal water loss, skin adverse reaction, and satisfaction are evaluated.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24
• Study Start: 2023-07-01
• Primary Completion: 2023-10-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Age 18 to 60 years
• No skin diseases
• No allergy to sericin and turmeric
• No immunocompromised disease or using steroid for 2 weeks before participated in this study
• Willing to participate in this study

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Exclusion Criteria

• Uncontrolled disease, cancer, and heart disease
• Cannot follow the protocol
• Pregnancy and lactation
• Participated in other studies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cream containing 5%sericin and 2%turmeric	cream containing 5%sericin and 2%turmeric	cream containing 5% sericin and 2%turmeric
cream containing 2.5% sericin and 2%turmeric	cream containing 2.5% sericin and 2%turmeric	cream containing 2.5% sericin and 2%turmeric
cream base	cream base	cream base without sericin and tumeric
cream containing 10%sericin and 2%turmeric	cream containing 10%sericin and 2%turmeric	cream containing 10% sericin and 2%turmeric

Primary Outcome Measures

Name	Time	Method
Erythema index	19 days	Measure by Cutometer. It represents inflammation. The value present in scale of erythema index (0 to 1000) (high value mean a worse outcome).
Melanin index	19 days	Measure by Cutometer. It represents post-inflammatory reaction. The value present in scale of melanin index (0 to 1000) (high value mean a worse outcome).

Secondary Outcome Measures

Name	Time	Method
Transepidermal water loss index	19 days	Measure by Cutometer. It represents skin water loss. The value present in scale of transepidermal water loss index (0 to 1000) (high value mean a worse outcome).
Satisfaction of the volunteers	19 days	Measure by visual analogue scale (1 to 10 score means low satisfaction to high satisfaction)
Skin reaction	19 days	Found or not found
Humidity index	19 days	Measure by Cutometer. It represents skin humidity. The value present in scale of humidity index (0 to 1000) (high value mean a better outcome).

Trial Locations

Locations (1)

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity; 🇹🇭 Bangkok, Thailand