Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

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

Study Overview

• Status: Not yet recruiting
• Conditions: Safety Issues
• Intervention / Treatment: Other: cream containing 2.5% sericin and 2%turmeric; Other: cream containing 5%sericin and 2%turmeric; Other: cream containing 10%sericin and 2%turmeric; Other: cream base

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 Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pornanong Aramwit, Professor; Phone Number: +66899217255; Email: aramwit@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10310
    • Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
    • Contact: Pornanong Aramwit, Ph.D; Phone Number: +66899217255; Email: aramwit@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cream containing 2.5% sericin and 2%turmeric	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.
Experimental: cream containing 5%sericin and 2%turmeric; cream containing 5% sericin and 2%turmeric	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.
Experimental: cream containing 10%sericin and 2%turmeric; cream containing 10% sericin and 2%turmeric	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.
Experimental: cream base; cream base without sericin and tumeric	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin reaction	Found or not found	19 days
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
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
Satisfaction of the volunteers	Measure by visual analogue scale (1 to 10 score means low satisfaction to high satisfaction)	19 days

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Pornanong Aramwit, Professor, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Turmeric extract
• Other Study ID Numbers: EC22010-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No