NCT05869357

Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safety Issues

Interventions

Type	Name	Description
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.
OTHER	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.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2023-10-30
• Completion: 2023-11-30
• First posted: 2023-05-22
• Last updated: 2023-05-24

Locations

1 site across 1 country: Thailand