crowfeet wrinkle feet_study.pdf · 6. participant agrees to continue to use of regular products...

1 BrighTexBio-Photonics, LLC

Your Artificial Intelligence Company

CROWFEET WRINKLE 3D Facial Contours & Under Eye Dark Circles

STUDY TEMPLATE



ABSTRACT

The primary objective of this clinical study is to assess the efficacy of a test product to

change the characteristics of the skin around the eyes 30 minutes post-application and after

four weeks and eight weeks of use.

Participant’s captures are taken using Clarity Research 3D System digital photography

atBaseline, Immediately (Approximately 30 minutes Post - Application) Week 4 and Week 8.

Measurements for the Participants will be recorded at Baseline(Visit 1), Week 4and Week

8after using the test product and it was concluded that there was a statistically significant

improvement from Baseline to Week 8 in Dark Circles (Increase in the Lstar value) which ranges

from 80.0% to 83.3%, Deep Wrinkles Average Length(mm) and Fine Wrinkles Surface Area

(%)under Wrinkles 2D which ranges from 50.0% to 60.0%, Surface Area (%) and Total Volume

under Wrinkles 3D which ranges from 46.7% to 66.7% and 3D Facial Contours (Total Raw

Volume) which ranges from 50.0% to 56.7%.



Section 1: OBJECTIVE

The primary objective of this clinical study is to assess the efficacy of a test product to change

the characteristics of the skin around the eyes 30 minutes post-application, crowfeet area after

four weeks and eight weeks of use.

A secondary objective of this clinical study is to obtain consumer perception of the product

through the use of a questionnaire following eight weeks of use.

Section 2: STUDY DESIGN

Approximately 30 female Participants are enrolled in this clinical study to assess the efficacy of

a test material immediately post-application, following four weeks and eight weeks of use and

to obtain the consumer perceptions of the test material following eight weeks of use. Study

evaluations will include Clarity Research 3D System imaging and consumer perception

questionnaires.

A study schedule appears below.

Study Procedures and

Evaluations

Screening(Day

– 7 + 2 Days Baseline

Immediately

(Approximately

30 Minutes

Post –

Application)

Week 4 Week 8

Informed Consent

Obtained

Inclusion and Exclusion

Criteria Verified

Clarity Research 3D

System Imaging

Test Material

Application in the



Laboratory

Test Materials, Daily

Diary, and Use

InstructionsDistributed

Test Material and Daily

Diary Collected

Consumer Perception

Questionnaire

Section 3: STUDY POPULATION

Each study's protocol has guidelines for who can or cannot (inclusion and exclusion criteria)

participate in the study. These guidelines, called eligibility criteria, describe characteristics that

must be shared by all Participants as part of the informed consent. The criteria differ

from study to study. They may include age, gender, medical history, and current health status.

A total of 30 Participants will be enrolled in the study. Participantsare recruited from the

Research centre panellist database.

3.1 INCLUSION CRITERIA

A Participant may be eligible for study participation if all of the following criteria are met: 1. Participant is female between 30 and 65 years of age;

2. Participant exhibits mild to moderate fine lines and wrinkles in the crow’s feet area;

3. Participant exhibits mild to moderate under eye puffiness;

4. Participant exhibits mild to moderate under eye dark circles due to circulation;

5. Participant agrees not to introduce any new cosmetic or toiletry products during the study;

6. Participant agrees to continue to use of regular products that are not eye serums or eye

creams, that do not contain anti-aging properties or are used anywhere except the test area

(crow’s feet and under eyes);

7. Participant agrees to refrain from use of her current eye serum or eye cream and to use

only the provided test material on the eye area and for the duration of the study;

8. Participant is dependable and able to follow directions as outlined in the protocol;



9. Participant is willing to participate in all study evaluations;

10. Participant is in generally good health and has a current Panelist Profile Form on file at LAB;

11. Participant agrees to sign a Photography Release Form, providing consent for the captureof

digital images for use in relation to this clinical study;

12. Participant has completed a HIPAA Authorization Form in conformance with 45 CFR Parts

160 and 164;

13. Participant understands and is willing to sign an Informed Consent Form in conformance

with 21 CFR Part 50: “Protection of Human Participants.”

3.2 EXCLUSION CRITERIA

A Participant is not eligible for study participation if any of the following criteria are met:

1. Participant is pregnant, nursing, planning a pregnancy, or not using adequate birth control;

2. Participant has received treatment with sympathomimetics,antihistamines,

vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical

corticosteroids within one week prior to initiation of the study;

3. Participant has a history of acute or chronic dermatologic, medical, and/or physical

conditions which would preclude application of the test material and/or could influence the

outcome of the study;

4. Participant is currently taking certain medications which, in the opinion of the Principal

Investigator, may interfere with the study;

5. Participant has known allergies to skin treatment products or cosmetics, toiletries, and/or

topical drugs.

3.3 PARTICIPANT TERMINATION AND WITHDRAWAL

A Participant may be discontinued from study participation at any time if the Principal

Investigator or designated medical staff feels that it is not in the Participant’s best interest to

continue.

All Participants are free to withdraw from participation at any time, for any reason, specified or

unspecified, and without prejudice. Reasonable attempts will be made by the Principal

Investigator or designee to provide a reason for Participant withdrawals. The reason for the



Participant’s withdrawal from the study will be specified in the Participant’s source documents

and included in the final report.

Section 4: TEST METHOD

4.1 PARTICIPANT IDENTIFICATION

All Participants will be initially identified by a permanent Clarity Research Laboratory

identification number. Once the Participant meets qualification criteria, a study Participant

number will be assigned. This permanent Participant number will be assigned in sequence as

Participants are enrolled in the study. 4.2 SCREENING

Participants will report to the testing facility. Informed consent will be obtained. Inclusion and

exclusion criteria will be verified. Participants will begin a 7-day (±2 days) conditioning phase

and will refrain from applying their usual eye serum/eye cream and any facial moisturizers.

4.3 BASELINE

Participants will return to the testing facility with clean faces, free from makeup. Participants

will acclimate to ambient laboratory conditions for approximately 15 minutes. Clarity Research

3D System imaging will be captured. Participants will apply the test material for the first time in

the laboratory under the supervision of Clarity Research Laboratory study staff. Approximately

30 minutes after application, Clarity Research 3D System imaging will be captured. Participants

will receive the test material, use instructions, and a daily diary to record use of the test

material. Participants will continue to use regular products that are not eye serums or eye

creams, that do not contain anti-aging properties or are used anywhere except the test area

(crow’s feet and under eyes).

4.4 WEEK 4



3D System imaging will be captured.



4.5 WEEK 8



3D System imaging will be captured. Participants will complete a consumer perception

questionnaire. Daily diaries will be reviewed for study compliance and collected. Unused test

materials will be collected.

Section 5: STUDY EVALUATIONS

5.1 CLARITY RESEARCH 3D SYSTEM

The Clarity Research 3D System features the latest technology in 2D and 3D skin modeling,

boasting 3 cameras, each with 25 megapixels and SLR image capture in 16- bit. The Automated

image recognition includes artificial intelligence for facial and skin area recognition, high

precision facial detection, automation for facial zoning and zoning by area of interest, and data

tracking by region of interest. The Clarity Research 3D System captures 6 types of skin images,

including diffuse white light, melanin, hemoglobin, texture, 3D macro structure, and 3D micro

structure. The system also allows for simultaneous front, left and right profile capture with no

repositioning requirements.

The Clarity Research 3D system is capable of detecting over 50 facial regions for analysis of fine

lines, texture, skin tone evenness and discoloration, and contouring. The system is alsoable to

perform 3D reconstruction of the skin topography and facial contour, facial volume analysis,

and facial fine lines / deep wrinkle surface analysis and to analyze acne scars and lesions,

redness scoring, subsurface pigment detection, pore detection, and visible spot detection.

Images will be obtained with eyes open and eyes closed.

The following parameters will be assessed at Baseline, Week 4 and Week 8:

•Under eye puffiness

•Under eye dark circles

•Fine lines and wrinkles in the crows' feet area

The following parameters will be assessed immediately post-application (approximately

30minutes):Under eye puffiness



5.2 SKIN FEATURE TO BE STUDIED

5.1.1 3D Facial Contours

This defines the degree of convexities and concavities on the facial region.

Measured Parameters:Total Raw Volume

i. Total Raw Volume:The total raw volume measured in under eye region. Decrease in Volume

indicates decrease in under eye puffiness.

Sample Result Images:

T0 T1

T2 T3

Participant 25 Results

1668.1621661.997

1660.967

1650.200

1640164516501655166016651670

Baseline Immediately (Approximately 30

Minutes) Post-Application

Week 4 Week 8

Rang

es

Time Points

Total Raw Volume



3D Overall Total Raw Volume:

Test Results and Statistical Summary

5.1.2 Crowfeet Wrinkles 2D

Structural changes in specific parts of the dermis and the subcutaneous tissue producing a fold,

ridge or crease on the skin is considered as a wrinkle.

Wrinkles feature is sub-categorized into three types Fine Lines, Emerging Lines and Deep Lines

based on the severity.

Clarity™ Research 3D System-Total Raw Volume

Parameter Treatment Visit Number of Participants

showed improvement

% of Participants showed

improvement

Total Raw

Volume Test Product

Immediately Post

Application 16 53.3%

Week 4 15 50.0%

Week 8 17 56.7%

1394.7981395.278

1394.3721394.010

139313941394139513951396

Baseline Immediately (Approximately 30

Minutes) Post-Application

Week 4 Week 8

Rang

es

Time Points

Overall 3D Total Raw Volume



Measured Parameters:Average Severity (Crow’s Feet), Wrinkle Object Count, Deep Wrinkles

Surface Area (%), Deep Wrinkles Average Severity, Deep Wrinkles Average Length (mm), Fine

Wrinkles Surface Area (%), Fine Wrinkles Average Severity


T0 T1

T2



i. Deep Wrinkles Average Length (mm): Average length of the deep wrinkles in milli

meter

Overall Deep Wrinkles Average Length (mm):


Clarity™ Research 3D System-Deep Wrinkles Average Length (mm)


showed improvement


improvement

Deep Wrinkles

Average

Severity

Test Product

Week 4 15 50.0%

Week 8 16 53.3%

22.03120.484 18.257

05

10152025

Baseline Week 4 Week 8

Rang

es

Time Points

Deep Wrinkles Average Length (mm)


21.397

21.128

20.569

20

21

21

22


Rang

es

Time Points

Overall Deep Wrinkles Average Length (mm)



ii. Fine Wrinkles Surface Area (%):Percentage of area effected by Fine Wrinkles

Overall Fine Wrinkles Surface Area (%):


Clarity™ Research 3D System-Fine Wrinkles Surface Area (%)


showed improvement


improvement

Fine Wrinkles

Surface Area

(%)

Test Product

Week 4 16 53.3%

Week 8 18 60.0%


37.170 36.561 36.341

0

10

20

30

40


Rang

es

Time Points

Overall Fine Wrinkles Surface Area (%)

42.042 34.92831.820

01020304050


Rang

es

Time Points

Wrinkles 2D - Fine Wrinkles Surface Area (%)



5.1.3 Crowfeet Wrinkles 3D

Structural changes in specific parts of the dermis and the subcutaneous tissue producing a fold,

ridge or crease on the skin is considered as a wrinkle.

Measured Parameters:Surface Area (%), Total Volume


T2 - Left T2 - Right

i. Surface Area (%):Percentage of area effected by Wrinkles recognized

32.282 31.280 25.740

0

10

20

30

40


Rang

es

Time Points

Wrinkles 3D - Surface Area (%)




Overall Surface Area (%):


ii. Total Volume:Total wrinkle volume of recognized wrinkles

Clarity™ Research 3D System-Surface Area (%)


showed improvement


improvement

Surface Area

(%) Test Product

Week 4 14 46.7%

Week 8 20 66.7%

39.470 39.243

38.399

383839394040


Rang

es

Time Points

Wrinkles 3D - Overall Surface Area (%)

387597.000366635.000

334105.500

300000320000340000360000380000400000


Rang

es

Time Points

Total Volume




Overall Total Volume:


5.1.4 Under Eye Dark Circles

The skin around the eyes displays expression and emotions that are an important part of our

individuality. Proper care of this area can provide long term benefits. Changes to the skin

around the eyes, can have functional, cosmetic and psychological ramifications.

Measured Parameter: Lstar

Lstar:As L* increases the brightness in Skin tone increases

The lightness value, L*, represents the darkest black at L*= 0, and the brightest white at L* =

100.

Clarity™ Research 3D System-Total Volume


showed improvement


improvement

Total Volume Test Product Week 4 14 46.7%

Week 8 15 50.0%

527724.200

538076.150

523284.980

515000520000525000530000535000540000


Rang

es

Time Points

Overall Total Volume




T0 T1

T2 T3

57.73758.275 58.500

57

58

58

59

59


Rang

es

Time Points

Lstar




Lstar Overall:

Improvements Observed: Increase in Lstar from Baseline to Week 8


Section 6: Product Use Instructions Use the test material once per day, in the evening. Gently squeeze the serum from the tube

onto the skin care device applicator. Massage around and under the eye area including the

crow’s feet area after cleansing and before moisturizing.

Section 7: Consumer Perception Questionnaire

Response options: Strongly Agree, Agree, Disagree, and Strongly Disagree

1. My fine lines and wrinkles in the crows’ feet area look less noticeable.

2. The test material reduced the appearance of dark under-eye circles.

Clarity™ Research 3D System-Lstar


showed improvement


improvement

L star Test Product Week 4 24 80.0%

Week 8 25 83.3%

60.963

62.04362.215

606161626263


Rang

es

Time Points

Overall Lstar



3. The ceramic-tip applicator is cooling.

4. The test material instantly reduces puffiness.

5. The test material instantly refreshes the skin.

6. The test material exfoliates dead skin cells.

7. The test material does not leave a residue.

8. Makeup goes on smoothly when applied over serum.

Section 8: CONCLUSION

Dark Circles feature showed significant improvement fromBaseline to Week 8which ranges

from 80.0% to 83.3%.

3D Facial Contours (Total Raw Volume)showed significant improvement from Baseline to Week

8 which ranges from 50.0% to 56.7%

The following parameters showed improvements inCrowfeet Wrinkles 2D: Average Severity,

Wrinkle Object Count, Deep Wrinkles Surface Area (%), Deep Wrinkles Average Severity, Deep

Wrinkles Average Length(mm), Fine Wrinkles Surface Area (%) and Fine Wrinkles Average

Severityshowed significant improvement from Baseline to Week 8 which ranges from 33.3 % to

60.0 %.

The following parameters showed improvements inCrowfeet Wrinkles3D:

Surface Area (%) and Total Volume showed significant improvement from Baseline to Week

8which ranges from 46.7% to 66.7%.

crowfeet wrinkle feet_study.pdf · 6. participant agrees to continue to use of regular products...

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