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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05041205
Other study ID # C210201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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