Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement

NCT05872113 | Completed

• 1 other identifier: GIRB-21929-NY
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

All subjects used the placebo sample on the left side of their face and the investigational sample on the right side of their face, respectively. The moisturizing levels were detected before use (0 week), after 2 weeks and after 4 weeks. The wrinkles of subjects were also measured on the same date interval as the skin moisture level test.

Conditions

Dry Skin

Outcome Measures

Primary Outcomes (2)

• Evaluation of Human Efficacy for Skin Moisturization Improvement through visual assessment

  The skin moisture level of subjects were also measured on the 0, 2, 4 weeks. skin moisturizing level was conducted using a Corneometer CM825 (Courage and Khazaka, Köln, Germany). The measurement of skin moisturization used capacitance, and the difference in dielectric constant between water and the measuring material was expressed as a measured value.

  up to 4 weeks

• Evaluation of Human Efficacy for skin Wrinkle Improvement through visual assessment

  The skin wrinkles of subjects were measured on the 0, 2, and 4 weeks. Skin wrinkles were approximated by visual assessment using an Antera 3D CS (Miravex, Ireland). The depth (Depth, mm) image of the Wrinkle-small analysis mode was used as evaluation data for skin wrinkle measurement. The measuring device was a device that can measure the condition of the skin's epidermis and dermis using a light emitting diode (LED light source), extract data from three-dimensional shape images, quantify skin conditions, and monitor skin changes over time to measure skin wrinkles.

  up to 4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The subjects who were on a placebo were put on the cream two times per day for 4 weeks. The questionnaire for testing the effects progressed when before using the cream, after 2 weeks, and after 4 weeks.

Combination Product: Placebo cream

Experiment

EXPERIMENTAL

The subjects who were on experimental were put on the cream two times per day for 4 weeks. The questionnaire for testing the effects progressed when before using the cream, after 2 weeks, and after 4 weeks.

Combination Product: Hs-hWE cream

Interventions

Hs-hWE cream COMBINATION_PRODUCT

The cream was applied to the faces of subjects, the left facial area was put on the 0.5% Hs-WE cream.

Experiment

Placebo cream COMBINATION_PRODUCT

The cream was applied to the faces of subjects, the right facial area was put on the placebo cream.

Placebo

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females with dried skin, aged 30-59 years (average=49.2 yrs).
• The subject has eye wrinkles (crow's feet).
• A person who has voluntarily signed consent after fully explaining the test purpose and content.
• Those who can follow up during the test period.
• A healthy person without acute or chronic physical disease including skin disease.

You may not qualify if:

• Pregnant or lactating women and women of childbearing age who do not agree to the contraceptive method prescribed by the protocol.
• A person with a lesion at the test site or suffering from an infectious skin disease.
• People with allergies or hypersensitivity, or irritation to cosmetics, pharmaceuticals, or daily exposure to light.
• Those who have received systemic steroids or phototherapy within 1 month of participating in the trial, or who have received skin treatment (scaling/botox/filler/laser/tattoo) within 3 months of participating in the trial.
• Those who have used drugs with similar functions at the research site within 3 months before the start of the study, or have a mental illness, or mental retardation disorder.
• Other than the above, a person who will make it difficult to conduct a human test based on the judgment of the responsible researcher or the person in charge of the study.

Sponsors & Collaborators

• Ji Hye Yoon: lead
• COSMAX: collaborator
• Global medical research center: collaborator

Study Sites (1)

Sungkyunkwan university

Suwon, 16419, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: May 24, 2023
• Study Start: October 1, 2021
• Primary Completion: November 5, 2021
• Study Completion: November 16, 2021
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)