Clinical trial NCT05872113: Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement
Official title: Product A (Test Product), Product B (Control Product) Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Skin
Lead sponsor: Sungkyunkwan University
Sponsor class: OTHER
Collaborators: name: COSMAX
name: Global medical research center
First posted: 2023-05-24
Enrollment: 22
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of Human Efficacy for Skin Moisturization Improvement through visual assessment
timeFrame: up to 4 weeks
measure: Evaluation of Human Efficacy for skin Wrinkle Improvement through visual assessment
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Sungkyunkwan university
Study officials:
References: