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Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

Sponsor
Chulalongkorn University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05869357
Collaborator
(none)
106
Enrollment
1
Location
4
Arms
5
Anticipated Duration (Months)
21.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers.

Condition or Disease Intervention/Treatment Phase
  • Other: cream containing 2.5% sericin and 2%turmeric
  • Other: cream containing 5%sericin and 2%turmeric
  • Other: cream containing 10%sericin and 2%turmeric
  • Other: cream base
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: cream containing 2.5% sericin and 2%turmeric

cream containing 2.5% sericin and 2%turmeric

Other: 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.
Experimental: cream containing 5%sericin and 2%turmeric

cream containing 5% sericin and 2%turmeric

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.
Experimental: cream containing 10%sericin and 2%turmeric

cream containing 10% sericin and 2%turmeric

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.
Experimental: cream base

cream base without sericin and tumeric

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.

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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 Outcome Measures

  1. 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).

  2. 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).

  3. Skin reaction [19 days]

    Found or not found

  4. Satisfaction of the volunteers [19 days]

    Measure by visual analogue scale (1 to 10 score means low satisfaction to high satisfaction)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity Bangkok Thailand 10310

Sponsors and Collaborators

  • Chulalongkorn University

Investigators

  • Principal Investigator: Pornanong Aramwit, Professor, Chulalongkorn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT05869357
Other Study ID Numbers:
  • EC22010-20
First Posted:
May 22, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Turmeric extract

Study Results

No Results Posted as of May 24, 2023