Dry SkinNCT05872113
Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement
A study testing Hs-hWE cream in people with Dry Skin, run by Ji Hye Yoon at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 30 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dry Skin
- What is being tested?
- Hs-hWE cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2021to 16 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Product A (Test Product), Product B (Control Product) Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement
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.
Read the 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.
- Conditions
- Dry Skin
- Being tested
- Hs-hWE cream, Placebo cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hs-hWE creamCombination product
The cream was applied to the faces of subjects, the left facial area was put on the 0.5% Hs-WE cream.
Placebo creamCombination product
The cream was applied to the faces of subjects, the right facial area was put on the placebo cream.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Hs-hWE cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Oct 2021
- Primary completion5 Nov 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ji Hye Yoon
- Sponsor type
- University, hospital or other
- Collaborators
- COSMAX, Global medical research center
- Responsible party
- Sponsor-investigator, Ji Hye Yoon, Sungkyunkwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872113
- Sponsor's protocol ID
- GIRB-21929-NY
- Status last verified
- May 2023
- First submitted
- 28 Mar 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Product A (Test Product), Product B (Control Product) Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement
- ClinicalTrials.gov ID
- NCT05872113
- Acronym / sponsor ID
- GIRB-21929-NY
- Conditions
- Dry Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ji Hye YoonUniversity, hospital or other
- Collaborators
- COSMAX, Global medical research center
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Combination Product: Placebo creamThe 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. |
| Experiment | Experimental | Combination Product: Hs-hWE creamThe 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. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hs-hWE creamThe cream was applied to the faces of subjects, the left facial area was put on the 0.5% Hs-WE cream. | Combination product | Experiment |
| Placebo creamThe cream was applied to the faces of subjects, the right facial area was put on the placebo cream. | Combination product | Placebo |
Primary outcome
Evaluation of Human Efficacy for Skin Moisturization Improvement through visual assessment
Time frame: up to 4 weeks
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.
Evaluation of Human Efficacy for skin Wrinkle Improvement through visual assessment
Time frame: up to 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hs-hWE cream in people with Dry Skin, run by Ji Hye Yoon at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Human Efficacy for Skin Moisturization Improvement through visual assessment (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.