Beauty Drink PowderNCT05041205
Functional Test for a Drink Powder Alone and Combined Use With a Cosmetic Apparatus
A study testing Beauty drink powder and Cosmetic apparatus in people with Beauty Drink Powder and Cosmetic Apparatus on Skin, run by Pharmanex at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Beauty Drink Powder, Cosmetic Apparatus on Skin, Skin Elasticity
- What is being tested?
- Beauty drink powder and Cosmetic apparatus
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2021to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, 200072
About this study
Official title: 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.
Read the 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
- Conditions
- Beauty Drink Powder, Cosmetic Apparatus on Skin, Skin Elasticity, Skin Dryness, Skin Moisture, Skin Evenness
- Being tested
- Beauty drink powder, Cosmetic apparatus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beauty drink powderDietary supplement
Beauty drink powder is designed as a oral beauty product to provide benefits to skin
Cosmetic apparatusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control group | Placebo comparator | placebo drink powder without active ingredients, 1 sachet per day with 50 ml water for 12 weeks Receives: Dietary Supplement: Beauty drink powder |
| Beauty drink powder group | Experimental | Beauty drink powder is the test article provide to participants, 1 sachet per day with 50 ml water for 12 weeks Receives: Dietary Supplement: Beauty drink powder |
| cosmetic apparatus group | Placebo comparator | 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. Receives: Device: Cosmetic apparatus |
| Beauty drink powder + cosmetic apparatus group | Experimental | 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. Receives: Dietary Supplement: Beauty drink powder; Device: Cosmetic apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, day 28, day 56, and day 84
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
Measured: baseline, day 28, day 56, and day 84
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
Measured: baseline, day 28, day 56, and day 84
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
Measured: baseline, day 28, day 56, and day 84
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
Measured: baseline, day 28, day 56, and day 84
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
Measured: baseline, day 28, day 56, and day 84
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
Measured: baseline, day 28, day 56, and day 84
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
Measured: baseline, day 28, day 56, and day 84
Secondary outcomes (7)
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
Measured: Baseline, day 28, day 56, and day 84
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
Measured: Baseline, day 28, day 56, and day 84
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
Measured: Baseline, day 28, day 56, and day 84
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
Measured: Baseline, day 28, day 56, and day 84
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
Measured: Baseline, day 28, day 56, and day 84
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
Measured: Baseline, day 28, day 56, and day 84
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
Measured: Baseline, day 28, day 56, and day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start22 May 2021
- Primary completion21 Jun 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beauty Drink PowderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenwen Gu, PhD, Principal investigator, Shanghai China-norm Quality Technical Service Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041205
- Sponsor's protocol ID
- C210201
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Test for a Drink Powder: a Randomized, Double-blind, Placebo-controlled Human Consumption Test
- ClinicalTrials.gov ID
- NCT05041205
- Acronym / sponsor ID
- C210201
- Conditions
- Beauty Drink Powder, Cosmetic Apparatus on Skin, Skin Elasticity, Skin Dryness, Skin Moisture, Skin Evenness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Study start
- 22 May 2021 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Placebo control group | Placebo comparator | Dietary Supplement: Beauty drink powderplacebo drink powder without active ingredients, 1 sachet per day with 50 ml water for 12 weeks |
| Beauty drink powder group | Experimental | Dietary Supplement: Beauty drink powderBeauty drink powder is the test article provide to participants, 1 sachet per day with 50 ml water for 12 weeks |
| cosmetic apparatus group | Placebo comparator | Device: Cosmetic apparatusThis 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. |
| Beauty drink powder + cosmetic apparatus group | Experimental | Dietary Supplement: Beauty drink powder, Device: Cosmetic apparatusIn 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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beauty drink powderBeauty drink powder is designed as a oral beauty product to provide benefits to skin | Dietary supplement | Beauty drink powder + cosmetic apparatus group, Beauty drink powder group, Placebo control group |
| Cosmetic apparatusThis 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. | Device | Beauty drink powder + cosmetic apparatus group, cosmetic apparatus group |
Primary outcome
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
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
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
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
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
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
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
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
7 secondary outcomes
Skin roughness and wrinkle of face determined by VisioScan VC20
Time frame: 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
Skin Glossiness of face determined by Glossymeter
Time frame: 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
Face TEWL determined by Vapometer
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenwen Gu, PhD principal investigator
Shanghai China-norm Quality Technical Service Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beauty drink powder and Cosmetic apparatus in people with Beauty Drink Powder and Cosmetic Apparatus on Skin, run by Pharmanex at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin health (evenness) (time frame: baseline, day 28, day 56, and day 84). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021; AzTrials last refreshed its copy on 30 Oct 2026.