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

Skin Elasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05041205
• Other study ID #: C210201
• Status: Completed
• Phase: N/A
• Start date: May 22, 2021
• Est. completion date: August 16, 2021

Study information

• Verified date: September 2021
• Source: Pharmanex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 16, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Elasticity

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai China-norm Quality Technical Service Co., Ltd.	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Pharmanex

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Skin roughness and wrinkle of face determined by VisioScan VC20	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
Secondary	Skin Color of L, a, b and ITA value of face determined by chromameter	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
Secondary	Skin Glossiness of face determined by Glossymeter	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
Secondary	Skin hydration of face determined by Corneometer	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
Secondary	Face TEWL determined by Vapometer	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
Secondary	Skin elasticity of face determined by Cutometer	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
Secondary	Skin radiance and lines assessed by facial photo capture using VISIA-CR and VISIA-7	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