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Completed

NCT Number: NCT05041205

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

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.

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Key information

Conditions

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

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 200072, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beauty drink powder

Dietary Supplement

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

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Pharmanex

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2021
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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