A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks

NCT06274450 | Completed

• 1 other identifier: C2202112
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 who were offered a rosa roxburghii and pomegranate drink.

Conditions

Skin Laxity

Keywords

Skin conditions

Outcome Measures

Primary Outcomes (12)

• Changes in the skin hydration

  Obtain change of skin hydration by Corneometer.

  Week0（Baseline）、Week4、Week8

• Changes in the skin glossiness

  Obtain change of skin glossiness by Glossymeter.

  Week0（Baseline）、Week4、Week8

• Changes in the skin firmness

  Obtain change of skin firmness by cutometer.

  Week0（Baseline）、Week4、Week8

• Changes in the skin elasticity

  Obtain change of skin elasticity by cutometer.

  Week0（Baseline）、Week4、Week8

• Changes in the individual type angle

  Obtain change of Individual type angle by Colorimeter.

  Week0（Baseline）、Week4、Week8

• Changes in the melanin content

  Obtain change of melanin content by Mexameter MX18.

  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.

  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.

  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.

  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.

  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.

  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.

  Week8

Secondary Outcomes (1)

• Changes in the satisfaction with the quality of life

  Week0（Baseline）、Week4、Week8

Study Arms (2)

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.

Combination Product: skin care product; Other: Drinks with active ingredients Rosa Roxburghii and Pomegranate

Blank Group

OTHER

Not taking drinks

Combination Product: skin care product

Interventions

skin care product COMBINATION_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

Blank Group; Drinks with active ingredients Rosa Roxburghii and Pomegranate

Drinks with active ingredients Rosa Roxburghii and Pomegranate OTHER

Take drinks with active ingredients such as Rosa Roxburghii and Pomegranate. Drink every morning on an empty stomach, 20ml/2 sachets/day.

Drinks with active ingredients Rosa Roxburghii and Pomegranate

Eligibility Criteria

• Age: 25 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Botanee Group Co., Ltd.: lead

Study Sites (1)

Shanghai China-norm Quality Technical Service Co ，Ltd

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Cutis Laxa; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhan Wang, Master

  Shenzhen Fubiyu Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: February 23, 2024
• Study Start: July 6, 2022
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: February 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)