Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
1 other identifier
interventional
106
1 country
1
Brief Summary
The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedMay 24, 2023
May 1, 2023
4 months
May 11, 2023
May 22, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Humidity index
19 days
Transepidermal water loss index
19 days
Skin reaction
19 days
Satisfaction of the volunteers
19 days
Study Arms (4)
cream containing 2.5% sericin and 2%turmeric
EXPERIMENTALcream containing 2.5% sericin and 2%turmeric
cream containing 5%sericin and 2%turmeric
EXPERIMENTALcream containing 5% sericin and 2%turmeric
cream containing 10%sericin and 2%turmeric
EXPERIMENTALcream containing 10% sericin and 2%turmeric
cream base
EXPERIMENTALcream base without sericin and tumeric
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Uncontrolled disease, cancer, and heart disease
- Cannot follow the protocol
- Pregnancy and lactation
- Participated in other studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Bangkok, 10310, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pornanong Aramwit, Professor
Chulalongkorn University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 11, 2023
First Posted
May 22, 2023
Study Start
July 1, 2023
Primary Completion
October 30, 2023
Study Completion
November 30, 2023
Last Updated
May 24, 2023
Record last verified: 2023-05