Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement

Ji Hye Yoon

Status: Completed

Conditions: Dry Skin

Treatments: Combination Product: Hs-hWE cream; Combination Product: Placebo cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05872113

GIRB-21929-NY

Details and patient eligibility

About

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.

Full description

Twenty-two subjects were initially enrolled in the clinical trial. One subject was excluded by non-compliance with the plan of trials. 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 crow's feet of subjects were also measured on the same date interval as the skin moisture level test.

Enrollment: 22 patients

Sex: Female

Ages: 30 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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22 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Combination Product: Placebo cream

Experiment

Experimental group

Description:

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.

Treatment:

Combination Product: Hs-hWE cream