The skin improvement effect of two skin cream products
| ISRCTN | ISRCTN77018521 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77018521 |
| ClinicalTrials.gov number | NCT05872113 |
| Secondary identifying numbers | GIRB-21929-NY |
- Submission date
- 30/03/2023
- Registration date
- 11/05/2023
- Last edited
- 05/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Skin changes are one of the representative symptoms of ageing. The aim of this study is to investigate the effects of plant extracts on the skin, focusing specifically on whether they help reduce skin wrinkles and moisturise the skin.
Who can participate?
Healthy women aged 30-59 years
What does the study involve?
The cream was made in two types, one was the A cream and the other was a placebo (dummy cream) for estimating the effects of plant extract. All participants put on this cream two times per day for 4 weeks, the A cream on the left side of the face and the placebo on the right. A questionnaire is completed before using the cream, after 2 weeks, and after 4 weeks. Skin wrinkles and skin moisturizing levels are assessed.
What are the possible benefits and risks of participating?
The participants may benefit from reduced skin wrinkles and moisturised skin. However, only one side of the face may improve.
Where is the study run from?
Global Medical Research Center (South Korea)
When is the study starting and how long is it expected to run for?
October 2021 to November 2021
Who is funding the study?
Ministry of Food and Drug Safety (South Korea)
Who is the main contact?
Prof. Jae youl Cho, jaecho67@gmail.com
Contact information
Scientific
2066 Seobu-ro
Jangan-gu
Suwon-si
Gyeonggi-do
Suwon
16419
Korea, South
 ORCID ID |
0000-0001-8141-9927 |
|---|---|
| Phone | +82-031-290-7878 |
| jaecho67@gmail.com |
Study information
| Study design | Interventional double-blind randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Product A (test product), product B (control product) evaluation of human efficacy for skin moisturization and wrinkle improvement |
| Study acronym | TSIEOCFA2P |
| Study objectives | Product A reduces skin wrinkles and upregulates skin moisture levels more than product B |
| Ethics approval(s) | Approved 01/10/2021, Institutional Review Board of Global Medical Research Center (82, Naruteo-ro, Seocho-gu, Seoul, Republic of Korea; +82 (0)70 4139 0795; girb@gmrc.co.kr), ref: GMRC-21O08-EA1 |
| Health condition(s) or problem(s) studied | Dry skin |
| Intervention | The cream was made in two types, one was the A cream and the other was a placebo (dummy cream) for estimating the effects of plant extract. All participants put on this cream two times per day for 4 weeks, the A cream on the left side of the face and the placebo on the right. A questionnaire is completed before using the cream, after 2 weeks, and after 4 weeks. Skin wrinkles and skin moisturizing levels are assessed. |
| Intervention type | Supplement |
| Primary outcome measure | The skin wrinkle is measured using a visual assessment using an Antera 3D CS (Miravex, Ireland) at baseline, 0, 2, and 4 weeks. The skin moisture level was conducted using a Corneometer CM825 (Courage and Khazaka, Köln, Germany) at baseline, 0, 2, and 4 weeks. |
| Secondary outcome measures | The skin wrinkle is measured using a visual assessment using an Antera 3D CS (Miravex, Ireland) at baseline, 0, 2, and 4 weeks. The skin moisture level was conducted using a Corneometer CM825 (Courage and Khazaka, Köln, Germany) at baseline, 0, 2, and 4 weeks. |
| Overall study start date | 01/10/2021 |
| Completion date | 16/11/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 22 |
| Total final enrolment | 21 |
| Key inclusion criteria | 1. Females with dried skin, aged 30-59 years 2. The subject has eye wrinkles (crow’s feet) 3. A person who has voluntarily signed consent after fully explaining the test purpose and content 4. Those who can follow up during the test period 5. A healthy person without acute or chronic physical disease including skin disease |
| Key exclusion criteria | 1. Pregnant or lactating women and women of childbearing age who do not agree to the contraceptive method prescribed by the protocol 2. A person with a lesion at the test site or suffering from an infectious skin disease 3. People with allergies or hypersensitivity, or irritation to cosmetics, pharmaceuticals, or daily exposure to light 4. 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 5. 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 6. 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 |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 07/10/2021 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Gangnam-gu
Seoul
06035
Korea, South
Sponsor information
Industry
Pangyo Innovalley E, F dong, 255
Pangyo-ro
Bundang-gu
Seongnam-si
Gyeonggi-do
Pan-gyo
13486
Korea, South
| Phone | +82 (0)31 789 3000 |
|---|---|
| jblee@cosmax.com | |
| Website | https://www.cosmax.com/main.asp |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- MFDS
- Location
- Korea, South
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in MDPI journal |
| IPD sharing plan | The datasets generated during the study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/05/2023 | 05/12/2023 | Yes | No |
Editorial Notes
05/12/2023: Publication reference and ClinicalTrials.gov number added.
21/04/2023: Trial's existence confirmed by the Institutional Review Board of the Global Medical Research Center.
