Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

Safety Issues Clinical Trial

Official title:

Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05869357
• Other study ID #: EC22010-20
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2023
• Source: Chulalongkorn University
• Contact: Pornanong Aramwit, Professor
• Phone: +66899217255
• Email: aramwit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: November 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Exclusion Criteria:

• Uncontrolled disease, cancer, and heart disease

• Cannot follow the protocol

• Pregnancy and lactation

• Participated in other studies

Related Conditions & MeSH terms

• Safety Issues

Intervention

Other:
• cream containing 2.5% sericin and 2%turmeric
Sample is applied 2 times/day for 6 days. Then, use of the sample is stopped for 7 to 10 days. After that, sample is applied 2 times/day for 3days.
• cream containing 5%sericin and 2%turmeric
Sample is applied 2 times/day for 6 days. Then, use of the sample is stopped for 7 to 10 days. After that, sample is applied 2 times/day for 3days.
• cream containing 10%sericin and 2%turmeric
Sample is applied 2 times/day for 6 days. Then, use of the sample is stopped for 7 to 10 days. After that, sample is applied 2 times/day for 3days.
• cream base
Sample is applied 2 times/day for 6 days. Then, use of the sample is stopped for 7 to 10 days. After that, sample is applied 2 times/day for 3days.

Locations

Country	Name	City	State
Thailand	Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythema index	Measure by Cutometer. It represents inflammation. The value present in scale of erythema index (0 to 1000) (high value mean a worse outcome).	19 days
Primary	Melanin index	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).	19 days
Secondary	Humidity index	Measure by Cutometer. It represents skin humidity. The value present in scale of humidity index (0 to 1000) (high value mean a better outcome).	19 days
Secondary	Transepidermal water loss index	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).	19 days
Secondary	Skin reaction	Found or not found	19 days
Secondary	Satisfaction of the volunteers	Measure by visual analogue scale (1 to 10 score means low satisfaction to high satisfaction)	19 days