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

September 2, 2021 updated by: Pharmanex

Functional Test for a Drink Powder: a Randomized, Double-blind, Placebo-controlled Human Consumption Test

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Shanghai China-norm Quality Technical Service Co., Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo control group
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 is designed as a oral beauty product to provide benefits to skin
Experimental: 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
Dietary supplement: Beauty drink powder
Beauty drink powder is designed as a oral beauty product to provide benefits to skin
Placebo Comparator: 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.
Device: 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.
Experimental: 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.
Dietary supplement: Beauty drink powder
Beauty drink powder is designed as a oral beauty product to provide benefits to skin
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin health (evenness)
Time Frame: baseline, day 28, day 56, and day 84
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)
Time Frame: baseline, day 28, day 56, and day 84
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)
Time Frame: baseline, day 28, day 56, and day 84
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)
Time Frame: baseline, day 28, day 56, and day 84
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)
Time Frame: baseline, day 28, day 56, and day 84
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)
Time Frame: baseline, day 28, day 56, and day 84
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)
Time Frame: baseline, day 28, day 56, and day 84
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)
Time Frame: baseline, day 28, day 56, and day 84
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin roughness and wrinkle of face determined by VisioScan VC20
Time Frame: Baseline, day 28, day 56, and day 84
Change from baseline in skin roughness and wrinkle at days 28, 56, and 84 using Wilcoxon and Mann-Whitney test for nonparametric data
Baseline, day 28, day 56, and day 84
Skin Color of L, a, b and ITA value of face determined by chromameter
Time Frame: Baseline, day 28, day 56, and day 84
Change from baseline in skin color of L, a, b, and ITA value at days 28, 56, and 84 using Wilcoxon and Mann-Whitney test for nonparametric data
Baseline, day 28, day 56, and day 84
Skin Glossiness of face determined by Glossymeter
Time Frame: Baseline, day 28, day 56, and day 84
Change from baseline in skin glossiness at days 28, 56, and 84 using Wilcoxon and Mann-Whitney test for nonparametric data
Baseline, day 28, day 56, and day 84
Skin hydration of face determined by Corneometer
Time Frame: Baseline, day 28, day 56, and day 84
Change from baseline in skin hydration at days 28, 56, and 84 using Wilcoxon and Mann-Whitney test for nonparametric data
Baseline, day 28, day 56, and day 84
Face TEWL determined by Vapometer
Time Frame: Baseline, day 28, day 56, and day 84
Change from baseline in face TEWL at days 28, 56, and 84 using Wilcoxon and Mann-Whitney test for nonparametric data
Baseline, day 28, day 56, and day 84
Skin elasticity of face determined by Cutometer
Time Frame: Baseline, day 28, day 56, and day 84
Change from baseline in skin elasticity at days 28, 56, and 84 using Wilcoxon and Mann-Whitney test for nonparametric data
Baseline, day 28, day 56, and day 84
Skin radiance and lines assessed by facial photo capture using VISIA-CR and VISIA-7
Time Frame: Baseline, day 28, day 56, and day 84
Change from baseline in skin radiance and lines at days 28, 56, and 84 using Wilcoxon and Mann-Whitney test for nonparametric data
Baseline, day 28, day 56, and day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmanex

Investigators

  • Principal Investigator: Wenwen Gu, PhD, Shanghai China-norm Quality Technical Service Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2021

Primary Completion (Actual)

June 21, 2021

Study Completion (Actual)

August 16, 2021

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • C210201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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