Beauty Image Efficacy Study

January 27, 2021 updated by: Pharmanex
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

28 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Beauty Image
Dietary supplement: Beauty Image
1.97g/package; 2 packages one day for 8 weeks
PLACEBO_COMPARATOR: Placebo Control
Dietary supplement: Placebo Control
Placebo Control; 1.97g/package; 2 packages one day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4 and Week 8
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.
Baseline, Week 4 and Week 8
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.
Baseline, Week 4 and Week 8.
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.
Baseline, Week 4 and Week 8
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.
Baseline, Week 4 and Week 8
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.
Baseline, Week 4 and Week 8.
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.
Baseline, Week 4 and Week 8.
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.
Baseline, Week 4 and Week 8.
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.
Baseline, Week 4 and Week 8.
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.
Baseline, Week 4 and Week 8.
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
Baseline, Week 4 and Week 8.
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
Baseline, Week 4 and Week 8.
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
Baseline, Week 4 and Week 8.
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
Baseline, Week 4 and Week 8.
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
Baseline, Week 4 and Week 8.
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
Baseline, Week 4 and Week 8.
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
Baseline, Week 1, Week 2, Week 4 and Week 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharmanex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C180201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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