Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

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

Detailed Description
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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.

Official Title
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Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

Conditions
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Safety Issues

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cream containing 2.5% sericin and 2%turmeric<br>cream containing 2.5% sericin and 2%turmeric | Other: cream containing 2.5% sericin and 2%turmeric<br>* 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.<br>|
| Experimental: cream containing 5%sericin and 2%turmeric<br>cream containing 5% sericin and 2%turmeric | Other: cream containing 5%sericin and 2%turmeric<br>* 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.<br>|
| Experimental: cream containing 10%sericin and 2%turmeric<br>cream containing 10% sericin and 2%turmeric | Other: cream containing 10%sericin and 2%turmeric<br>* 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.<br>|
| Experimental: cream base<br>cream base without sericin and tumeric | Other: cream base<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Skin reaction | Found or not found | 19 days | 
| Satisfaction of the volunteers | Measure by visual analogue scale (1 to 10 score means low satisfaction to high satisfaction) | 19 days |