Safety IssuesNCT05869357
Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
A study testing cream containing 2.5% sericin and 2%turmeric, cream containing 5%sericin and 2%turmeric and cream containing 10%sericin and 2%turmeric in people with Safety Issues, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- cream containing 2.5% sericin and 2%turmeric, cream containing 5%sericin and 2%turmeric and cream containing 10%sericin and 2%turmeric
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Uncontrolled disease, cancer, and heart disease
- Cannot follow the protocol
- Pregnancy and lactation
- Participated in other studies
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Bangkok, 10310
Pornanong Aramwit, Ph.D, +66899217255, aramwit@gmail.com
About this study
The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers.
Read the 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.
- Conditions
- Safety Issues
- Being tested
- cream containing 2.5% sericin and 2%turmeric, cream containing 5%sericin and 2%turmeric, cream containing 10%sericin and 2%turmeric, cream base
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cream containing 2.5% sericin and 2%turmericOther
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 5%sericin and 2%turmericOther
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%turmericOther
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 baseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| cream containing 2.5% sericin and 2%turmeric | Experimental | cream containing 2.5% sericin and 2%turmeric Receives: Other: cream containing 2.5% sericin and 2%turmeric |
| cream containing 5%sericin and 2%turmeric | Experimental | cream containing 5% sericin and 2%turmeric Receives: Other: cream containing 5%sericin and 2%turmeric |
| cream containing 10%sericin and 2%turmeric | Experimental | cream containing 10% sericin and 2%turmeric Receives: Other: cream containing 10%sericin and 2%turmeric |
| cream base | Experimental | cream base without sericin and tumeric Receives: Other: cream base |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 19 days
Secondary outcomes (4)
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).
Measured: 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).
Measured: 19 days
Skin reaction
Found or not found
Measured: 19 days
Satisfaction of the volunteers
Measure by visual analogue scale (1 to 10 score means low satisfaction to high satisfaction)
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
- Investigators
- Pornanong Aramwit, Professor, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869357
- Sponsor's protocol ID
- EC22010-20
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05869357
- Acronym / sponsor ID
- EC22010-20
- Conditions
- Safety Issues
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cream containing 2.5% sericin and 2%turmeric | Experimental | Other: cream containing 2.5% sericin and 2%turmericcream containing 2.5% sericin and 2%turmeric |
| cream containing 5%sericin and 2%turmeric | Experimental | Other: cream containing 5%sericin and 2%turmericcream containing 5% sericin and 2%turmeric |
| cream containing 10%sericin and 2%turmeric | Experimental | Other: cream containing 10%sericin and 2%turmericcream containing 10% sericin and 2%turmeric |
| cream base | Experimental | Other: cream basecream base without sericin and tumeric |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Uncontrolled disease, cancer, and heart disease
- Cannot follow the protocol
- Pregnancy and lactation
- Participated in other studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cream containing 2.5% sericin and 2%turmericSample 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. | Other | cream containing 2.5% sericin and 2%turmeric |
| cream containing 5%sericin and 2%turmericSample 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. | Other | cream containing 5%sericin and 2%turmeric |
| cream containing 10%sericin and 2%turmericSample 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. | Other | cream containing 10%sericin and 2%turmeric |
| cream baseSample 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. | Other | cream base |
Primary outcome
Erythema index
Time frame: 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
Time frame: 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).
4 secondary outcomes
Humidity index
Time frame: 19 days
Transepidermal water loss index
Time frame: 19 days
Skin reaction
Time frame: 19 days
Satisfaction of the volunteers
Time frame: 19 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pornanong Aramwit, Professor principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cream containing 2.5% sericin and 2%turmeric, cream containing 5%sericin and 2%turmeric and cream containing 10%sericin and 2%turmeric in people with Safety Issues, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pornanong Aramwit, Professor (+66899217255, aramwit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythema index (time frame: 19 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.