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The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cream containing 2.5% sericin and 2%turmeric | Experimental | cream containing 2.5% sericin and 2%turmeric |
|
| cream containing 5%sericin and 2%turmeric | Experimental | cream containing 5% sericin and 2%turmeric |
|
| cream containing 10%sericin and 2%turmeric | Experimental | cream containing 10% sericin and 2%turmeric |
|
| cream base | Experimental | cream base without sericin and tumeric |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cream containing 2.5% sericin and 2%turmeric | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pornanong Aramwit, Professor | Contact | +66899217255 | aramwit@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pornanong Aramwit, Professor | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity | Bangkok | 10310 | Thailand |
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| ID | Term |
|---|---|
| D047030 | Sericins |
| ID | Term |
|---|---|
| D047011 | Silk |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| cream containing 5%sericin and 2%turmeric | Other | 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 | Other | 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 | Other | 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. |
|
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 |
| D060829 |
| Arthropod Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |