Skin AgingNCT04733755

Beauty Image Efficacy Study

A study testing Beauty Image in people with Skin Aging, run by Pharmanex at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective is to evaluate the effects of oral supplement of a blend containing collagen peptides, phosphatidylserine, Saussurea involucrata and lutein (Beauty Image) on the improvement of skin aging in terms of hydration, gloss, melanin content, roughness and wrinkling, and anti-UV performance. Read more about this study

Who is it for?: Ages 28 to 55 years
Conditions the study is for: Skin Aging
What is being tested?: Beauty Image
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteChina
Study dates: 1 May 2018to 1 Sep 2018
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 28 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Facial skin with problems of dull, uneven, inelastic, dryness and wrinkle/fine line (At least fit to two problems)
In general good health and good mental state;
Willing to read, understand and able to sign the Informed Consent Form;
Willing to comply with all study protocol requirements.

Who cannot join

Intention to become pregnant, pregnant, lactating or within 6 months of delivery;
Participation in any clinical test or cosmetic product test on skin within 30 days;
Existence of neurodermatitis, pityriasis, seborrheic dermatitis or psoriasis capitis on test area;
Use of any anti-inflammatory drugs in the past 2 months;
A history of skin diseases such as psoriasis, eczema, psoriasis, skin cancer, etc.;
IDDM: Insulin dependent diabetic patients;

Show all 11Show fewer

Current treatment for asthma or other chronic respiratory diseases;
Undergoing anticancer chemotherapy in the past 6 months;
Existence of any other health problems or chronic diseases;
Use of retinoids, alpha hydroxyl acid, ortho-hydroxybenzoic acid, hydroquinone nearly within 3 months; or use of prescriptions (such as antibiotics, retinoids, alpha hydroxyl acid or steroids), oral contraceptives (Use of same contraceptives for 6 months excepted);
Existence of the following conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, diabetes, vascular disease, hepatitis, eczema, psoriasis.

Trial locations and contacts

1 site in 1 country.

China1 site

Nu Skin (China) Daily-use & Health Products CO., LTD
Shanghai, Shanghai Municipality

Other trials in China

About this study

Conditions: Skin Aging
Being tested: Beauty Image, Placebo Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Beauty ImageDietary supplement
1.97g/package; 2 packages one day for 8 weeks
Placebo ControlDietary supplement
Placebo Control; 1.97g/package; 2 packages one day for 8 weeks

Study groups in NCT04733755
Study group	Role	What they receive
Beauty Image	Experimental	Not described Receives: Dietary Supplement: Beauty Image
Placebo Control	Placebo comparator	Not described Receives: Dietary Supplement: Placebo Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in facial photo from baseline at week 4 and week 8
Facial Photo Capture by VISIA-CR CR (CANFIELD, America). The instrument captured all-face skin under different light sources about the Standard 1, Standard 2, UV light, Parallel-polarized light and Cross-polarized light source with left, front and right sides design.
Measured: Baseline, Week 4 and Week 8
Change in skin roughness from baseline at week 4 and week 8
Skin Roughness: VisioScan VC98 (Courage \& Khazaka, Germany). The instrument consists of a special b/w video sensor chip with very high resolution, an objective and a ring shaped UVA-light source in a small, easy-to-handle, ergonomically designed plastic casing. The parameter of SEr (skin roughness) was analyzed in this study.
Measured: Baseline, Week 4 and Week 8
Change in skin wrinkle from baseline at week 4 and week 8
Skin Wrinkle: VisioScan VC98 (Courage \& Khazaka, Germany) The instrument consists of a special b/w video sensor chip with very high resolution, an objective and a ring shaped UVA-light source in a small, easy-to-handle, ergonomically designed plastic casing. The parameter of SEw (wrinkles) was analyzed in this study.
Measured: Baseline, Week 4 and Week 8.
Change in skin color from baseline at week 4 and week 8
Skin Color of L, a, b and ITA: Spectrophotometer CM2600d (Konica Minolta, Japan) The Minolta spectrophotometer (Konica Minolta, CM2600d) is generally used to measure and carry out quality control of the color of an object. This instrument allows measurement in the modes of specular component included (SCI) and specular component excluded (SCE). As indicated by the description, SCI includes the specular reflection while SCE excludes the specular reflection from measured surface. The parameters of L, a, b value under SCE light source were recorded and the ITA value were calculated in this study.
Measured: Baseline, Week 4 and Week 8
Change in melanin content from baseline at week 4 and week 8
Melanin Content: Mexameter MX18 (Courage \& Khazaka, Germany) The measurement is based on absorption/reflection. The probe of the Mexameter® MX 18 emits 3 specific light wavelengths. A receiver measures the light reflected by the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated. The melanin is measured by specific wavelengths chosen to correspond to different absorption rates by the pigments. For the erythema measurement specific wavelengths are also used, corresponding to the spectral absorption peak of haemoglobin and to avoid other color influences.
Measured: Baseline, Week 4 and Week 8
Change in skin gloss from baseline at week 4 and week 8
Skin Gloss: Glossymeter GL200 (Courage \& Khazaka, Germany) The probe sends out white LED light, arranged circularly to uniformly illuminate the skin. The emitted light is scattered in all directions, some parts travel through the layers and some is scattered out of the skin. The light reflected from the skin is measured in the probe. The raw data of the probe are corrected with a special color matrix to adapt them closely to standard values and are expressed accordingly.
Measured: Baseline, Week 4 and Week 8.
Change in skin hydration from baseline at week 4 and week 8
Skin Hydration: Corneometer CM825 (Courage \& Khazaka, Germany) It measures moisture content of the skin via capacitance measurements. The measurable capacitance is proportional to the water content of stratum corneum, given that other physical and physiological variables affecting skin electrical properties are carefully controlled.
Measured: Baseline, Week 4 and Week 8.
Change in transepidermal water Loss from baseline at week 4 and week 8
Transepidermal Water Loss (TEWL): Vapometer (Delfin Technologies, Finland) It's equipped with a closed cylindrical chamber. When it is in contact with the skin, the relative humidity (RH %) in the chamber increases, based on which transepidermal water loss (TEWL) is calculated. Lower TEWL means better skin barrier function. Vapometer measurement will be done at the tested areas on face skin.
Measured: Baseline, Week 4 and Week 8.
Change in skin elasticity from baseline at week 4 and week 8
Skin Elasticity: Cutometer dual MPA580 (Courage \& Khazaka, Germany) The Cutometer® is destined to measure elasticity of the upper skin layer using negative pressure which deforms the skin mechanically.
Measured: Baseline, Week 4 and Week 8.
Change in anti-ultraviolet from baseline at week 4 and week 8
Evaluation of Anti-ultraviolet
- Skin Carotenoid level was measured by NUSKIN S3 Biophotonic Scanner, this instrument measured on hand (the part of the hand between the thumb and the index finger).
- The size and redness of sunburns were measured at 24hours after UV exposure with fixed light source and distance on back skin.
Measured: Baseline, Week 4 and Week 8.
Change in dermatologist grading of skin tone dullness from baseline at week 4 and week 8
The skin parameter of skin tone dullness was assessed through '0 to 5' scales
Measured: Baseline, Week 4 and Week 8.
Change in dermatologist grading of skin tone unevenness from baseline at week 4 and week 8
The skin parameter of skin tone unevenness was assessed through '0 to 5' scales
Measured: Baseline, Week 4 and Week 8.
Change in dermatologist grading of skin dryness from baseline at week 4 and week 8
The skin parameter of skin dryness was assessed through '0 to 5' scales
Measured: Baseline, Week 4 and Week 8.
Change in dermatologist grading of skin inelastic from baseline at week 4 and week 8
The skin parameter of skin inelastic was assessed through '0 to 5' scales
Measured: Baseline, Week 4 and Week 8.
Change in dermatologist grading of wrinkle/fine line from baseline at week 4 and week 8
The skin parameter of wrinkle/fine line was assessed through '0 to 5' scales
Measured: Baseline, Week 4 and Week 8.
Change in dermatologist grading of skin roughness from baseline at week 4 and week 8
The skin parameter of skin roughness was assessed through '0 to 5' scales
Measured: Baseline, Week 4 and Week 8.
Self Assessment
A self assessment questionnaire about skin conditions improvement was answered by each subject
Measured: Baseline, Week 1, Week 2, Week 4 and Week 8.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20181 Sep 2018

First posted2 Feb 2021
Study start1 May 2018
Primary completion1 Aug 2018
Study completion1 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Skin AgingStudies 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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04733755
Sponsor's protocol ID: C180201
Status last verified: Jan 2021
First submitted: 27 Jan 2021
Last updated: 2 Feb 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationEarly Phase 1
Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks
Aging
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
Skin Aging, Dry Skin
Not yet recruiting
Evaluation of MD60002 Device for Facial Skin Aging
Facial Wrinkles, Skin Aging
RecruitingPhase 3
Safety and Effectiveness of NOA HYDRATION Injectable Gel for the Improvement of Skin Quality Including Attributes Such as Skin Smoothness
Skin Quality
Active, not recruiting
Effects of a Multi-Targeted Oral Supplement on Skin, Hair, Sleep, Energy, Cognition, Libido and Epigenetic Biological Clock Age
Skin Ageing, Healthy Ageing

All Skin Aging trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Beauty Image Efficacy Study
ClinicalTrials.gov ID: NCT04733755
Acronym / sponsor ID: C180201
Conditions: Skin Aging
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: PharmanexIndustry (pharma, biotech, devices)
Study start: 1 May 2018 (actual)
Primary completion: 1 Aug 2018 (actual)
Study completion: 1 Sep 2018 (actual)
First posted: 2 Feb 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Beauty Image	Experimental	Dietary Supplement: Beauty Image
Placebo Control	Placebo comparator	Dietary Supplement: Placebo Control

Who may qualify

Ages: 28 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Facial skin with problems of dull, uneven, inelastic, dryness and wrinkle/fine line (At least fit to two problems)
In general good health and good mental state;
Willing to read, understand and able to sign the Informed Consent Form;
Willing to comply with all study protocol requirements.

Key exclusion criteria (11 listed)

Intention to become pregnant, pregnant, lactating or within 6 months of delivery;
Participation in any clinical test or cosmetic product test on skin within 30 days;
Existence of neurodermatitis, pityriasis, seborrheic dermatitis or psoriasis capitis on test area;
Use of any anti-inflammatory drugs in the past 2 months;
A history of skin diseases such as psoriasis, eczema, psoriasis, 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 Image1.97g/package; 2 packages one day for 8 weeks	Dietary supplement	Beauty Image
Placebo ControlPlacebo Control; 1.97g/package; 2 packages one day for 8 weeks	Dietary supplement	Placebo Control

Primary outcome

Change in facial photo from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8
Facial Photo Capture by VISIA-CR CR (CANFIELD, America). The instrument captured all-face skin under different light sources about the Standard 1, Standard 2, UV light, Parallel-polarized light and Cross-polarized light source with left, front and right sides design.
Change in skin roughness from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8
Skin Roughness: VisioScan VC98 (Courage \& Khazaka, Germany). The instrument consists of a special b/w video sensor chip with very high resolution, an objective and a ring shaped UVA-light source in a small, easy-to-handle, ergonomically designed plastic casing. The parameter of SEr (skin roughness) was analyzed in this study.
Change in skin wrinkle from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
Skin Wrinkle: VisioScan VC98 (Courage \& Khazaka, Germany) The instrument consists of a special b/w video sensor chip with very high resolution, an objective and a ring shaped UVA-light source in a small, easy-to-handle, ergonomically designed plastic casing. The parameter of SEw (wrinkles) was analyzed in this study.
Change in skin color from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8
Skin Color of L, a, b and ITA: Spectrophotometer CM2600d (Konica Minolta, Japan) The Minolta spectrophotometer (Konica Minolta, CM2600d) is generally used to measure and carry out quality control of the color of an object. This instrument allows measurement in the modes of specular component included (SCI) and specular component excluded (SCE). As indicated by the description, SCI includes the specular reflection while SCE excludes the specular reflection from measured surface. The parameters of L, a, b value under SCE light source were recorded and the ITA value were calculated in this study.
Change in melanin content from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8
Melanin Content: Mexameter MX18 (Courage \& Khazaka, Germany) The measurement is based on absorption/reflection. The probe of the Mexameter® MX 18 emits 3 specific light wavelengths. A receiver measures the light reflected by the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated. The melanin is measured by specific wavelengths chosen to correspond to different absorption rates by the pigments. For the erythema measurement specific wavelengths are also used, corresponding to the spectral absorption peak of haemoglobin and to avoid other color influences.
Change in skin gloss from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
Skin Gloss: Glossymeter GL200 (Courage \& Khazaka, Germany) The probe sends out white LED light, arranged circularly to uniformly illuminate the skin. The emitted light is scattered in all directions, some parts travel through the layers and some is scattered out of the skin. The light reflected from the skin is measured in the probe. The raw data of the probe are corrected with a special color matrix to adapt them closely to standard values and are expressed accordingly.
Change in skin hydration from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
Skin Hydration: Corneometer CM825 (Courage \& Khazaka, Germany) It measures moisture content of the skin via capacitance measurements. The measurable capacitance is proportional to the water content of stratum corneum, given that other physical and physiological variables affecting skin electrical properties are carefully controlled.
Change in transepidermal water Loss from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
Transepidermal Water Loss (TEWL): Vapometer (Delfin Technologies, Finland) It's equipped with a closed cylindrical chamber. When it is in contact with the skin, the relative humidity (RH %) in the chamber increases, based on which transepidermal water loss (TEWL) is calculated. Lower TEWL means better skin barrier function. Vapometer measurement will be done at the tested areas on face skin.
Change in skin elasticity from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
Skin Elasticity: Cutometer dual MPA580 (Courage \& Khazaka, Germany) The Cutometer® is destined to measure elasticity of the upper skin layer using negative pressure which deforms the skin mechanically.
Change in anti-ultraviolet from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
Evaluation of Anti-ultraviolet * Skin Carotenoid level was measured by NUSKIN S3 Biophotonic Scanner, this instrument measured on hand (the part of the hand between the thumb and the index finger). * The size and redness of sunburns were measured at 24hours after UV exposure with fixed light source and distance on back skin.
Change in dermatologist grading of skin tone dullness from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
The skin parameter of skin tone dullness was assessed through '0 to 5' scales
Change in dermatologist grading of skin tone unevenness from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
The skin parameter of skin tone unevenness was assessed through '0 to 5' scales
Change in dermatologist grading of skin dryness from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
The skin parameter of skin dryness was assessed through '0 to 5' scales
Change in dermatologist grading of skin inelastic from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
The skin parameter of skin inelastic was assessed through '0 to 5' scales
Change in dermatologist grading of wrinkle/fine line from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
The skin parameter of wrinkle/fine line was assessed through '0 to 5' scales
Change in dermatologist grading of skin roughness from baseline at week 4 and week 8
Time frame: Baseline, Week 4 and Week 8.
The skin parameter of skin roughness was assessed through '0 to 5' scales
Self Assessment
Time frame: Baseline, Week 1, Week 2, Week 4 and Week 8.
A self assessment questionnaire about skin conditions improvement was answered by each subject

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 2 Feb 2021.
Individual participant dataSharing planned: No

Related trials for Skin Aging

Enrolling by invitationEarly Phase 1
Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks
Aging
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
Skin Aging, Dry Skin
Not yet recruiting
Evaluation of MD60002 Device for Facial Skin Aging
Facial Wrinkles, Skin Aging
RecruitingPhase 3
Safety and Effectiveness of NOA HYDRATION Injectable Gel for the Improvement of Skin Quality Including Attributes Such as Skin Smoothness
Skin Quality
Active, not recruiting
Effects of a Multi-Targeted Oral Supplement on Skin, Hair, Sleep, Energy, Cognition, Libido and Epigenetic Biological Clock Age
Skin Ageing, Healthy Ageing

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Image in people with Skin Aging, 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 4 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 2 Feb 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?

Change in facial photo from baseline at week 4 and week 8 (time frame: Baseline, Week 4 and Week 8). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04733755.

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 2 Feb 2021.