Clinical trial NCT05041205: Functional Test for a Drink Powder Alone and Combined Use With a Cosmetic Apparatus
Official title: Functional Test for a Drink Powder: a Randomized, Double-blind, Placebo-controlled Human Consumption Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beauty Drink Powder
Cosmetic Apparatus on Skin
Skin Elasticity
Skin Dryness
Skin Moisture
Skin Evenness
Skin Firmness
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
First posted: 2021-09-10
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to four group during the study: a placebo control group, a beauty drink powder group, a cosmetic apparatus group, and a beauty drink powder + cosmetic apparatus group
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Skin health (evenness)
timeFrame: baseline, day 28, day 56, and day 84
measure: Skin health (radiance)
timeFrame: baseline, day 28, day 56, and day 84
measure: Skin health (elastisity)
timeFrame: baseline, day 28, day 56, and day 84
measure: Skin health (smoothness)
timeFrame: baseline, day 28, day 56, and day 84
measure: Skin health (firmness)
timeFrame: baseline, day 28, day 56, and day 84
measure: Skin health (moisture)
timeFrame: baseline, day 28, day 56, and day 84
measure: Skin health (plumpness)
timeFrame: baseline, day 28, day 56, and day 84
measure: Skin health (overall)
timeFrame: baseline, day 28, day 56, and day 84
Secondary outcomes:
measure: Skin roughness and wrinkle of face determined by VisioScan VC20
timeFrame: Baseline, day 28, day 56, and day 84
measure: Skin Color of L, a, b and ITA value of face determined by chromameter
timeFrame: Baseline, day 28, day 56, and day 84
measure: Skin Glossiness of face determined by Glossymeter
timeFrame: Baseline, day 28, day 56, and day 84
measure: Skin hydration of face determined by Corneometer
timeFrame: Baseline, day 28, day 56, and day 84
measure: Face TEWL determined by Vapometer
timeFrame: Baseline, day 28, day 56, and day 84
measure: Skin elasticity of face determined by Cutometer
timeFrame: Baseline, day 28, day 56, and day 84
measure: Skin radiance and lines assessed by facial photo capture using VISIA-CR and VISIA-7
timeFrame: Baseline, day 28, day 56, and day 84
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai China-norm Quality Technical Service Co., Ltd.
state: Shanghai
Study officials:
affiliation: Shanghai China-norm Quality Technical Service Co., Ltd.
name: Wenwen Gu, PhD
role: PRINCIPAL_INVESTIGATOR
References: