Safety Issues
Conditions
Brief 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.
Interventions
OTHERcream 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.
OTHERcream 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.
OTHERcream 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.
OTHERcream 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.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythema index | 19 days | Measure by Cutometer. It represents inflammation. The value present in scale of erythema index (0 to 1000) (high value mean a worse outcome). |
| Melanin index | 19 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Humidity index | 19 days | Measure by Cutometer. It represents skin humidity. The value present in scale of humidity index (0 to 1000) (high value mean a better outcome). |
| Transepidermal water loss index | 19 days | 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). |
| Skin reaction | 19 days | Found or not found |
| Satisfaction of the volunteers | 19 days | Measure by visual analogue scale (1 to 10 score means low satisfaction to high satisfaction) |
Countries
Thailand
Contacts
Primary ContactPornanong Aramwit, Professor
Outcome results
None listed