Skin LaxityNCT06274450
A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks
A study testing skin care product and Drinks with active ingredients Rosa Roxburghii and Pomegranate in people with Skin Laxity, run by Botanee Group Co., Ltd. at 1 site in China.
Trial summary
The main objective of the study is to observe changes in the subjects' skin condition and life status after 8 weeks of drinking rosa roxburghii and pomegranate drinks. This is a single-center, randomized, single-blind, controlled, 8-week (56-day) clinical study conducted in Chinese healthy women aged 25-45 years old… Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- skin care product and Drinks with active ingredients Rosa Roxburghii and Pomegranate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2022to 2 Sep 2022
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 25-45 years old, Chinese female;
- The subject's self-reported facial problems such as dryness, roughness, dullness, and lack of elasticity;
- The subject's BMI is between 18~24kg/m2;
- After the doctor's clinical evaluation, there is at least one obvious pigmentation spot with an ITA° difference of more than 10° on the face and the surrounding adjacent skin, and the diameter is not less than 3mm (it cannot be freckles, pigmented nevi, etc. that are difficult to improve clinically using topical preparations);
- Corneometer base measurement of facial skin moisture at 15~45 (Corneometer Unit, C.U.) Between;
- Be in good health and free of any other chronic diseases other than skin problems or diseases being treated;
- Voluntarily participate in the test and sign the informed consent form;
- Willing to comply with all evaluation requirements;
Who cannot join
- Those who have used products, health foods or drugs with antioxidant and anti-aging effects in the past 2 months;
- Those who have used any products, health foods or drugs (such as hydroquinone preparations) that affect skin color in the past 2 months;
- Those who have used tretinoin preparations or undergone medical aesthetic treatments such as chemical peels, lasers, and pulsed light at the test site in the past 3 months;
- Those who are inevitably exposed to long-term sunlight;
- Intending to become pregnant, or being pregnant or breastfeeding;
- Have a history of alcoholism;
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- Have a history of allergies;
- Participated in any clinical trial evaluation within 1 month;
- Those who have applied any anti-inflammatory drugs to the test site within the past two months;
- Those who have suffered from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);
- patients with insulin-dependent diabetes;
- Patients with asthma or other chronic respiratory diseases who are being treated;
- Have taken/injected anti-allergic drugs in the past 1 month;
- Patients who have received anti-cancer chemotherapy or immunotherapy patients within the past 6 months;
- Have a serious internal medicine disease, have any other health problems or chronic diseases;
- Coated with retinoids, A hydroxy acids, salicylic acids, hydroquinone within the past 3 months, or prescription drugs (antibiotics, retinoids, A hydroxy acids and steroids) in use within the past 6 months, oral contraceptives (if you have been taking the same contraceptive pills for the past 6 months, you can continue to take them);
- Experts or professionals believe that there are other iatrogenic causes that affect the results of the review.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai China-norm Quality Technical Service Co ，Ltd
Shanghai, Shanghai Municipality, 200072
About this study
The main objective of the study is to observe changes in the subjects' skin condition and life status after 8 weeks of drinking rosa roxburghii and pomegranate drinks.
This is a single-center, randomized, single-blind, controlled, 8-week (56-day) clinical study conducted in Chinese healthy women aged 25-45 years old who were offered a rosa roxburghii and pomegranate drink.
Read the detailed description
The study population is 70 healthy Chinese women aged 25-45 years who report current problems with dryness, roughness, dullness, and lack of elasticity on their face. The subjects will be randomly divided into an experimental group and a control product group of 35 subjects each.
Subjects will be formally enrolled after site assessment and subsequent site visits and test product administration. During the test cycle, subjects in the test group will take Prickly Pear Pomegranate Drink with active ingredients for 8 weeks, while the control product group will not take any test product. In order to avoid the influence of different skincare products on the results, all subjects will be asked to use a basic skincare product with moisturising ingredients only, provided by the sponsor, for the duration of the test. The efficacy of the test products will be verified by comparing the changes in skin condition and lifestyle of the subjects in the experimental group before taking the test products and 4 weeks and 8 weeks after taking the test products, as well as by comparing the differences in skin condition and lifestyle between the experimental group and the control group.
- Conditions
- Skin Laxity
- Being tested
- skin care product, Drinks with active ingredients Rosa Roxburghii and Pomegranate
- Keywords
- Skin conditions
- Medical subject headings
- Cutis Laxa, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin care productCombination product
Subjects are uniformly using skin care products provided by the sponsor during the test. Skin care product include: WINONA sensitiveness relieving moisturizing cleansing foam, WINONA sensitiveness relieving moisturizing lotion, WINONA anti-sensitive tolerance-extreme moisturizing cream
Drinks with active ingredients Rosa Roxburghii and PomegranateOther
Take drinks with active ingredients such as Rosa Roxburghii and Pomegranate. Drink every morning on an empty stomach, 20ml/2 sachets/day.
| Study group | Role | What they receive |
|---|---|---|
| Drinks with active ingredients Rosa Roxburghii and Pomegranate | Experimental | Take drinks with active ingredients such as Rosa Roxburghii and Pomegranate. Drink every morning on an empty stomach, 20ml/2 sachets/day. Receives: Combination Product: skin care product; Other: Drinks with active ingredients Rosa Roxburghii and Pomegranate |
| Blank Group | Other | Not taking drinks Receives: Combination Product: skin care product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the skin hydration
Obtain change of skin hydration by Corneometer.
Measured: Week0（Baseline）、Week4、Week8
Changes in the skin glossiness
Obtain change of skin glossiness by Glossymeter.
Measured: Week0（Baseline）、Week4、Week8
Changes in the skin firmness
Obtain change of skin firmness by cutometer.
Measured: Week0（Baseline）、Week4、Week8
Changes in the skin elasticity
Obtain change of skin elasticity by cutometer.
Measured: Week0（Baseline）、Week4、Week8
Changes in the individual type angle
Obtain change of Individual type angle by Colorimeter.
Measured: Week0（Baseline）、Week4、Week8
Changes in the melanin content
Obtain change of melanin content by Mexameter MX18.
Measured: Week0（Baseline）、Week4、Week8
Changes in the proportion of crow's feet area
Calculate the proportion of crow's feet area by Visia CR images.
Measured: Week0（Baseline）、Week4、Week8
Changes in the proportion of fine lines under the eye
Calculate the proportion of fine lines under the eye by Visia CR images.
Measured: Week0（Baseline）、Week4、Week8
Changes in the CIE RGB of skin tone
Dermatologist use PANTONE SkinTone (Pantone color card) skin color guide to evaluate skin tone grade of subjects. Find the CIE RGB corresponding to the skin tone grade in Pantone ColorManager software and convert it into a color value using the formula for data analysis: CIE RGB = R+G*256+B*256*256.
Calculate the change of CIE RGB of skin tone.
Measured: Week0（Baseline）、Week4、Week8
Changes in the grade of Pigmentation
Obtain change of degree of Pigmentation severity by Dermatologist evaluation according to Skin Aging ATLAS of Asian Type.
Measured: Week0（Baseline）、Week4、Week8
Skin condition Assessment after 4-week application
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire. The questionnaire is a 9-point scale, with 1 indicating strong disagreement and 9 indicating strong agreement.
Measured: Week4
Skin condition Assessment after 8-week application
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire. The questionnaire is a 9-point scale, with 1 indicating strong disagreement and 9 indicating strong agreement.
Measured: Week8
Secondary outcomes (1)
Changes in the satisfaction with the quality of life
Obtain change of satisfaction with the quality of life accessed by WHOQOL-100 questionnaire. The questionnaire is a 5-point scale, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Measured: Week0（Baseline）、Week4、Week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start6 Jul 2022
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botanee Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhan Wang, Master, Principal investigator, Shenzhen Fubiyu Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274450
- Sponsor's protocol ID
- C2202112
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is used to develop new products, no decision has been made on when to disclose
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks
- ClinicalTrials.gov ID
- NCT06274450
- Acronym / sponsor ID
- C2202112
- Conditions
- Skin Laxity
- Keywords
- Skin conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Botanee Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 23 Feb 2024 (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.
The main objective of the study is to observe changes in the subjects' skin condition and life status after 8 weeks of drinking rosa roxburghii and pomegranate drinks.
This is a single-center, randomized, single-blind, controlled, 8-week (56-day) clinical study conducted in Chinese healthy women aged 25-45 years old who were offered a rosa roxburghii and pomegranate drink.
Detailed description
The study population is 70 healthy Chinese women aged 25-45 years who report current problems with dryness, roughness, dullness, and lack of elasticity on their face. The subjects will be randomly divided into an experimental group and a control product group of 35 subjects each.
Subjects will be formally enrolled after site assessment and subsequent site visits and test product administration. During the test cycle, subjects in the test group will take Prickly Pear Pomegranate Drink with active ingredients for 8 weeks, while the control product group will not take any test product. In order to avoid the influence of different skincare products on the results, all subjects will be asked to use a basic skincare product with moisturising ingredients only, provided by the sponsor, for the duration of the test. The efficacy of the test products will be verified by comparing the changes in skin condition and lifestyle of the subjects in the experimental group before taking the test products and 4 weeks and 8 weeks after taking the test products, as well as by comparing the differences in skin condition and lifestyle between the experimental group and the control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drinks with active ingredients Rosa Roxburghii and Pomegranate | Experimental | Combination Product: skin care product, Other: Drinks with active ingredients Rosa Roxburghii and PomegranateTake drinks with active ingredients such as Rosa Roxburghii and Pomegranate. Drink every morning on an empty stomach, 20ml/2 sachets/day. |
| Blank Group | Other | Combination Product: skin care productNot taking drinks |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 25-45 years old, Chinese female;
- The subject's self-reported facial problems such as dryness, roughness, dullness, and lack of elasticity;
- The subject's BMI is between 18~24kg/m2;
- After the doctor's clinical evaluation, there is at least one obvious pigmentation spot with an ITA° difference of more than 10° on the face and the surrounding adjacent skin, and the diameter is not less than 3mm (it cannot be freckles, pigmented nevi, etc. that are difficult to improve clinically using topical preparations);
- Corneometer base measurement of facial skin moisture at 15~45 (Corneometer Unit, C.U.) Between;
Key exclusion criteria (17 listed)
- Those who have used products, health foods or drugs with antioxidant and anti-aging effects in the past 2 months;
- Those who have used any products, health foods or drugs (such as hydroquinone preparations) that affect skin color in the past 2 months;
- Those who have used tretinoin preparations or undergone medical aesthetic treatments such as chemical peels, lasers, and pulsed light at the test site in the past 3 months;
- Those who are inevitably exposed to long-term sunlight;
- Intending to become pregnant, or being pregnant or breastfeeding;
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 |
|---|---|---|
| skin care productSubjects are uniformly using skin care products provided by the sponsor during the test. Skin care product include: WINONA sensitiveness relieving moisturizing cleansing foam, WINONA sensitiveness relieving moisturizing lotion, WINONA anti-sensitive tolerance-extreme moisturizing cream | Combination product | Blank Group, Drinks with active ingredients Rosa Roxburghii and Pomegranate |
| Drinks with active ingredients Rosa Roxburghii and PomegranateTake drinks with active ingredients such as Rosa Roxburghii and Pomegranate. Drink every morning on an empty stomach, 20ml/2 sachets/day. | Other | Drinks with active ingredients Rosa Roxburghii and Pomegranate |
Primary outcome
Changes in the skin hydration
Time frame: Week0（Baseline）、Week4、Week8
Obtain change of skin hydration by Corneometer.
Changes in the skin glossiness
Time frame: Week0（Baseline）、Week4、Week8
Obtain change of skin glossiness by Glossymeter.
Changes in the skin firmness
Time frame: Week0（Baseline）、Week4、Week8
Obtain change of skin firmness by cutometer.
Changes in the skin elasticity
Time frame: Week0（Baseline）、Week4、Week8
Obtain change of skin elasticity by cutometer.
Changes in the individual type angle
Time frame: Week0（Baseline）、Week4、Week8
Obtain change of Individual type angle by Colorimeter.
Changes in the melanin content
Time frame: Week0（Baseline）、Week4、Week8
Obtain change of melanin content by Mexameter MX18.
Changes in the proportion of crow's feet area
Time frame: Week0（Baseline）、Week4、Week8
Calculate the proportion of crow's feet area by Visia CR images.
Changes in the proportion of fine lines under the eye
Time frame: Week0（Baseline）、Week4、Week8
Calculate the proportion of fine lines under the eye by Visia CR images.
Changes in the CIE RGB of skin tone
Time frame: Week0（Baseline）、Week4、Week8
Dermatologist use PANTONE SkinTone (Pantone color card) skin color guide to evaluate skin tone grade of subjects. Find the CIE RGB corresponding to the skin tone grade in Pantone ColorManager software and convert it into a color value using the formula for data analysis: CIE RGB = R+G*256+B*256*256. Calculate the change of CIE RGB of skin tone.
Changes in the grade of Pigmentation
Time frame: Week0（Baseline）、Week4、Week8
Obtain change of degree of Pigmentation severity by Dermatologist evaluation according to Skin Aging ATLAS of Asian Type.
Skin condition Assessment after 4-week application
Time frame: Week4
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire. The questionnaire is a 9-point scale, with 1 indicating strong disagreement and 9 indicating strong agreement.
Skin condition Assessment after 8-week application
Time frame: Week8
Obtain data on agreement with skin condition improvement by skin condition self-assessment questionnaire. The questionnaire is a 9-point scale, with 1 indicating strong disagreement and 9 indicating strong agreement.
1 secondary outcome
Changes in the satisfaction with the quality of life
Time frame: Week0（Baseline）、Week4、Week8
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 23 Feb 2024.
- Individual participant dataSharing planned: No. Data is used to develop new products, no decision has been made on when to disclose
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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.
Zhan Wang, Master principal investigator
Shenzhen Fubiyu Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin care product and Drinks with active ingredients Rosa Roxburghii and Pomegranate in people with Skin Laxity, run by Botanee Group Co., Ltd. at 1 site in China.
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 8 inclusion and 17 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 23 Feb 2024. 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 China. 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. 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?
Changes in the skin hydration (time frame: Week0（Baseline）、Week4、Week8). The study lists 12 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 23 Feb 2024.