Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

NCT ID: NCT05869357

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-11-30

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.

Conditions

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Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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cream containing 2.5% sericin and 2%turmeric

cream containing 2.5% sericin and 2%turmeric

Group Type EXPERIMENTAL

cream containing 2.5% sericin and 2%turmeric

Intervention Type 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 5%sericin and 2%turmeric

cream containing 5% sericin and 2%turmeric

Group Type EXPERIMENTAL

cream containing 5%sericin and 2%turmeric

Intervention Type 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

cream containing 10% sericin and 2%turmeric

Group Type EXPERIMENTAL

cream containing 10%sericin and 2%turmeric

Intervention Type 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

cream base without sericin and tumeric

Group Type EXPERIMENTAL

cream base

Intervention Type 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.

Interventions

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cream 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.

Intervention Type OTHER

cream 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.

Intervention Type OTHER

cream 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.

Intervention Type OTHER

cream 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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Pornanong Aramwit, Pharm.D., Ph.D

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pornanong Aramwit, Professor

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity

Bangkok, , Thailand

Site Status

Countries

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Thailand

Central Contacts

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Pornanong Aramwit, Professor

Role: CONTACT

+66899217255

Facility Contacts

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Pornanong Aramwit, Ph.D

Role: primary

+66899217255

Other Identifiers

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EC22010-20

Identifier Type: -

Identifier Source: org_study_id

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