Functional Test for a Drink Powder Alone and Combined Use With a Cosmetic Apparatus

NCT ID: NCT05041205

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-22
• Study Completion Date: 2021-08-16

Brief Summary

This study is designed to observe human consuming effect of a beauty drink powder and combined use with a cosmetic apparatus. It is a randomized, double-blind, and placebo-control study. The target enrollment of subjects is 160 and 4 arms are included, a placebo control, drink powder alone, cosmetic apparatus alone, and drink powder plus cosmetic apparatus. Effects on skin dullness, skin tone unevenness, skin dryness, skin elasticity, wrinkle and fine line are evaluated. Both objective and subjective methods are used for efficacy evaluation. Data are collected at baseline, week 4, week 8, and week 12 after treatment.

Detailed Description

In this study, objective parameters are measured by the instruments as following: VisioScan VC20 is used for skin roughness and wrinkle assessment, chromameter CR-400 is used to assess skin color, skin gloss is assessed by Glossymeter, skin hydration is assessed by Corneometer, TEWL is assessed by Vapometer, and skin elasticity is assessed by Cutometer. VISIA-CR and VISIA-7 are used in skin radiation and wrinkle visualization.

Clinical assessment is performed by expert visual grading on

• Skin evenness
• Skin radiance
• Skin elasticity
• Skin smoothness
• Skin firmness
• Skin moisture
• Skin plumpness

Conditions

Beauty Drink Powder; Cosmetic Apparatus on Skin; Skin Elasticity; Skin Dryness; Skin Moisture; Skin Evenness; Skin Firmness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo control group

placebo drink powder without active ingredients, 1 sachet per day with 50 ml water for 12 weeks

Group Type: PLACEBO_COMPARATOR

Beauty drink powder

Intervention Type: DIETARY_SUPPLEMENT

Beauty drink powder is designed as a oral beauty product to provide benefits to skin

Beauty drink powder group

Beauty drink powder is the test article provide to participants, 1 sachet per day with 50 ml water for 12 weeks

Group Type: EXPERIMENTAL

Beauty drink powder

Intervention Type: DIETARY_SUPPLEMENT

Beauty drink powder is designed as a oral beauty product to provide benefits to skin

cosmetic apparatus group

This group is designed for a cosmetic apparatus control group without consumption of placebo or test article. Together with the specified cleanser, the apparatus is used for daily facial cleaning, two times in the morning and evening for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Cosmetic apparatus

Intervention Type: DEVICE

This device is designed to let participants to experience brighter, softer, smoother skin and an energizing facial massage. A synergestic effect when combine with beauty drink powder is expected.

Beauty drink powder + cosmetic apparatus group

In this group, Beauty drink powder is consumed 1 sachet daily with 50 ml water and the cosmetic apparatus is used together with the specified cleanser for daily facial cleaning, two times in the morning and evening for 12 weeks.

Group Type: EXPERIMENTAL

Beauty drink powder

Intervention Type: DIETARY_SUPPLEMENT

Beauty drink powder is designed as a oral beauty product to provide benefits to skin

Cosmetic apparatus

Intervention Type: DEVICE

This device is designed to let participants to experience brighter, softer, smoother skin and an energizing facial massage. A synergestic effect when combine with beauty drink powder is expected.

Interventions

Beauty drink powder

Beauty drink powder is designed as a oral beauty product to provide benefits to skin

Intervention Type: DIETARY_SUPPLEMENT

Cosmetic apparatus

This device is designed to let participants to experience brighter, softer, smoother skin and an energizing facial massage. A synergestic effect when combine with beauty drink powder is expected.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Chinese healthy male or female
• Subjects with skin problems such as skin dullness, skin tone unevenness, skin inelasticity, skin dryness, and wrinkle/fine lines.
• Subjects without any other chronic or on treatment diseases
• Subjects are voluntary to participate the trial and signed informed consents.
• Subjects are voluntary to follow all evaluation criteria

Exclusion Criteria

• Subjects have a plan to be pregnant, or are in pregnancy or lactation period;
• Not participated any clinical trial or evaluation within nearly 1 month;
• Used anti-histamine medication within nearly one week or immunosuppressor within nearly one month
• Used any anti-inflammation drugs at test site within nearly two months
• Subjects who have any skin diseases (psoriasis, eczema, skin cancer etc.)
• Subjects with Type I diabetes
• Subjects who currently are receiving asthma or other chronic respiratory diseases treatment
• Subjects who are receiving anti-cancer chemotherapy in nearly 6 months
• Subjects who have anyother health problem or chronic diseases
• Subjects who have externally used Vit A, a-hydroxy acid, salicylic acid, hydroquinone within nearly 3 months or prescription medicines, oral contraceptive within nearly 6 months
• Expert or professional person evaluate have other iatrogenic reason may impact the evaluation results

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pharmanex

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenwen Gu, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai China-norm Quality Technical Service Co., Ltd.

Locations

Shanghai China-norm Quality Technical Service Co., Ltd.

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

C210201

Identifier Type: -

Identifier Source: org_study_id