Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement

Dry Skin Clinical Trial

Official title:

Product A (Test Product), Product B (Control Product) Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05872113
• Other study ID #: GIRB-21929-NY
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: November 16, 2021

Study information

• Verified date: May 2023
• Source: Sungkyunkwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 16, 2021
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Skin

Intervention

Combination Product:
• Hs-hWE cream
The cream was applied to the faces of subjects, the left facial area was put on the 0.5% Hs-WE cream.
• Placebo cream
The cream was applied to the faces of subjects, the right facial area was put on the placebo cream.

Locations

Country	Name	City	State
Korea, Republic of	Sungkyunkwan university	Suwon

Sponsors (3)

Lead Sponsor	Collaborator
Ji Hye Yoon	COSMAX, Global medical research center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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