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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharmanex

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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