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

NCT05041205 | Completed

• 1 other identifier: C210201
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Skin health (evenness)

  Change from baseline in investigator facial grading of evenness (using scores from 0-10 to indicate skin evenness from evenness to unevenness) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data

  baseline, day 28, day 56, and day 84

• Skin health (radiance)

  Change from baseline in investigator facial grading of radiance (using scores from 0-10 to indicate skin radiance from radiance to dulness) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data

  baseline, day 28, day 56, and day 84

• Skin health (elastisity)

  Change from baseline in investigator facial grading of elastisity (using scores from 0-10 to indicate skin elasticity from elastic to nonelastic) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data

  baseline, day 28, day 56, and day 84

• Skin health (smoothness)

  Change from baseline in investigator facial grading of smoothness (using scores from 0-10 to indicate skin smoothness from smooth to rough) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data

  baseline, day 28, day 56, and day 84

• Skin health (firmness)

  Change from baseline in investigator facial grading of firmness (using scores from 0-10 to indicate skin firmness from firm to slack) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data

  baseline, day 28, day 56, and day 84

• Skin health (moisture)

  Change from baseline in investigator facial grading of moisture (using scores from 0-10 to indicate skin moisture from moist to dry) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data

  baseline, day 28, day 56, and day 84

• Skin health (plumpness)

  Change from baseline in investigator facial grading of plumness (using scores from 0-10 to indicate skin plumpness from plump to not plump) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data

  baseline, day 28, day 56, and day 84

• Skin health (overall)

  Change from baseline in investigator facial grading of overall (using scores from 0-10 to indicate overall skin health from good to worse) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data

  baseline, day 28, day 56, and day 84

Secondary Outcomes (7)

• Skin roughness and wrinkle of face determined by VisioScan VC20

  Baseline, day 28, day 56, and day 84

• Skin Color of L, a, b and ITA value of face determined by chromameter

  Baseline, day 28, day 56, and day 84

• Skin Glossiness of face determined by Glossymeter

  Baseline, day 28, day 56, and day 84

• Skin hydration of face determined by Corneometer

  Baseline, day 28, day 56, and day 84

• Face TEWL determined by Vapometer

  Baseline, day 28, day 56, and day 84

Study Arms (4)

Placebo control group

PLACEBO COMPARATOR

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

Dietary Supplement: Beauty drink powder

Beauty drink powder group

EXPERIMENTAL

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

Dietary Supplement: Beauty drink powder

cosmetic apparatus group

PLACEBO COMPARATOR

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.

Device: Cosmetic apparatus

Beauty drink powder + cosmetic apparatus group

EXPERIMENTAL

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.

Dietary Supplement: Beauty drink powder; Device: Cosmetic apparatus

Interventions

Beauty drink powder DIETARY_SUPPLEMENT

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

Beauty drink powder + cosmetic apparatus group; Beauty drink powder group; Placebo control group

Cosmetic apparatus 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; cosmetic apparatus group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanex: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200072, China

Location

Study Officials

• Wenwen Gu, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In this study, participants and outcomes assessors are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned to four group during the study: a placebo control group, a beauty drink powder group, a cosmetic apparatus group, and a beauty drink powder + cosmetic apparatus group

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 10, 2021
• Study Start: May 22, 2021
• Primary Completion: June 21, 2021
• Study Completion: August 16, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)