Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

Chulalongkorn University

Status: Not yet enrolling

Conditions: Safety Issues

Treatments: Other: cream containing 2.5% sericin and 2%turmeric; Other: cream base; Other: cream containing 5%sericin and 2%turmeric; Other: cream containing 10%sericin and 2%turmeric

Study type: Interventional

Funder types: Other

Identifiers

NCT05869357

EC22010-20

Details and patient eligibility

About

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

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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106 participants in 4 patient groups

cream containing 2.5% sericin and 2%turmeric

Experimental group

Description:

cream containing 2.5% sericin and 2%turmeric

Treatment:

Other: cream containing 2.5% sericin and 2%turmeric

cream containing 5%sericin and 2%turmeric

Experimental group

Description:

cream containing 5% sericin and 2%turmeric

Treatment:

Other: cream containing 5%sericin and 2%turmeric

cream containing 10%sericin and 2%turmeric

Experimental group

Description:

cream containing 10% sericin and 2%turmeric

Treatment:

Other: cream containing 10%sericin and 2%turmeric

cream base

Experimental group

Description:

cream base without sericin and tumeric

Treatment:

Other: cream base