Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement

NCT ID: NCT05872113

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2021-11-16

Brief Summary

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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

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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.

Conditions

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Dry Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo cream

Intervention Type COMBINATION_PRODUCT

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

Experiment

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.

Group Type EXPERIMENTAL

Hs-hWE cream

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Placebo cream

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

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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COSMAX

UNKNOWN

Sponsor Role collaborator

Global medical research center

UNKNOWN

Sponsor Role collaborator

Ji Hye Yoon

OTHER

Sponsor Role lead

Responsible Party

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Ji Hye Yoon

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sungkyunkwan university

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GIRB-21929-NY

Identifier Type: -

Identifier Source: org_study_id

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