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NCT05869357 | Not yet recruiting | Safety Issues


Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
Sponsor:

Chulalongkorn University

Information provided by (Responsible Party):

Pornanong Aramwit, Pharm.D., Ph.D

Brief Summary:

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

Condition or disease

Safety Issues

Intervention/treatment

cream containing 2.5% sericin and 2%turmeric

cream containing 5%sericin and 2%turmeric

cream containing 10%sericin and 2%turmeric

cream base

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 106 participants
Masking: Triple
Primary Purpose: Other
Official Title: Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : November 30, 2023
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

Experimental: cream containing 5%sericin and 2%turmeric

cream containing 5% sericin and 2%turmeric

Other: cream containing 5%sericin and 2%turmeric

Experimental: cream containing 10%sericin and 2%turmeric

cream containing 10% sericin and 2%turmeric

Other: cream containing 10%sericin and 2%turmeric

Experimental: cream base

cream base without sericin and tumeric

Other: cream base

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

Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

Location Details


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Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

How to Participate

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Locations


Not yet recruiting

Thailand,

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

Bangkok, Thailand, 10310

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