Study Summary

Title

An Eight-Week Clinical Study to Determine the Effectiveness of One (1) Hair Care Product

Protocol Number

3920YS0215

Sponsor

YaySave!

Methodology

Monadic (clinical evaluation), Controlled (Repeated Grooming Assay)

Objective

To evaluate the efficacy of a hair care product to improvethe appearance and condition of hair and scalp. 

Number of Subjects

30 to complete, target enrollment 34

Target Population

Male and Female subjects, age 30-70 years old

Duration

8 weeks (Baseline, Week 4 and Week 8) + optional 4-Week extension (Week 12)

Claims

Claim

Support

Reduces hair loss due to breakage

Repeated Grooming Assay

Improves strength of hair

Adds body and shine to hair

Subjective Questionnaire

Clinical Grading

Increases volume and thickness

Promotes healthy scalp

Reduces split ends

Provides deep hydration (to scalp)

Corneometer

Subjective Questionnaire

Study Products

Name

Formula Number

Pura d'or Hair Loss Prevention Therapy Shampoo

851615006006

Statistical Methodology

Descriptive statistics reported, change from Baseline (monadic: Paired T-test; mean at time point compared to baseline, p≤0.05, mean percent change compared to baseline. All final statistical analyses will be performed on the PP population.

Study Schedule

Initiation

Baseline (D0)

July 31, 2015

 

Begin Product Use (D3)

August 3, 2015

Interim

Week 4

August 28, 2015

Completion

Week 8

September 25, 2015

Option

Week 12

October 23, 2015

Schedule of Deliverables

Intermediate Topline

Week 4

September 14, 2015

Final Topline

Week 8

(Week 12 optional)

October 9, 2015

(November 6, 2015)

Photographs

5 Weeks after study completion

8-Week Study: October 30, 2015

12-Week Study: December 1, 2015

Draft Final Report:  

5 Weeks after study completion

8-Week Study: October 30, 2015

12-Week Study: December 1, 2015

Summary

This was an eight-week, monadic evaluation of the effects of one test product on the condition and appearance of hair and scalp.  A study panel of 32 subjects was enrolled in the study and 31 completed eight weeks of participation.  The study also included a single use controlled instrumental evaluation of the product performed on hair tresses to evaluate strength. 

Under the conditions of this study, use of Pura d'or Hair Loss Prevention Therapy Shampoo #851615006006led to significant improvements in hair and scalp appearance and in hair strength, as evidenced by results from expert clinical grading, hair strength testing and subjective questionnaire results.  See Section 20.0 Conclusion for further detail.


Quality Assurance Statement

 

This report accurately reflects the data derived from the procedures and materials tested in this study.  The conclusions are based on an interpretation of the data and have been reviewed by the Principal Investigator(s) and by personnel from International Research Services, Inc. responsible for assuring its accuracy.

 

 

Quality Assurance:

 

Kimberly A. Hammon

Director of Quality Assurance

E-mail: khammon@irsi.org

 

 

 

 

Principal Investigator:

 

Robert J. Frumento

IRSI VP Clinical and Corporate Operations

E-Mail:  rfrumento@irsi.org

 

 

 

 

 

 

IRSI President, CEO:

 

Stephen R. Schwartz

IRSI President, CEO

E-Mail:  sschwartz@irsi.org

 

 

 

 

 

 

 

 

Table of Contents

1.0 Introduction

2.0 Objectives

3.0 Study Design

4.0 Product

5.0 Population

6.0 Methods

7.0 Procedure

8.0 Concomitant Medications and Products

9.0 Adverse Events

10.0 Institutional Review Board

11.0 Informed Consent

12.0 Discontinuation of Study

13.0 Changes to the Protocol

14.0 Monitoring

15.0 Recording of Data

16.0 Quality Control and Quality Assurance

17.0 Ethics

18.0 Statistical Methods

19.0 Results

20.0 Conclusion

 

Appendices

Appendix I

Protocol

Appendix II

Protocol Amendment

Appendix III

Data Listing and Statistical Report

 

 

 

List of Abbreviations

 

AE

Adverse Event

BL

Baseline

C

Collect

CRFs

Case Report Forms

D

Dispense

D0

Day 0 (Baseline)

D1, 2, 3

Day 1, 2, 3

FDA

Federal Drug Administration

ICF

Informed Consent Form

ICH

International Conference on Harmonization

IRSI

International Research Services, Inc.

N

Number of Subjects

NI

No Improvement

PI

Principal Investigator

PP

Per protocol

SAE

Serious Adverse Event

SOP

Standard Operating Procedure

Sponsor

YaySave!

Tx

Time point x (i.e. Week 2, Week 4)

Wx

Study visit at Week X; “W2” = Week 2

 

Definitions

Monadic

Refers to type of testing methodology in this document in which only a single sample is evaluated.  The effects of the sample are evaluated and compared to Baseline measures.

Controlled

Refers to type of testing methodology in this document in which a sample is compared to a control.  The effects of the sample are evaluated and compared to the control product.

Study Product

The investigative product (Shampoo) provided by the Sponsor to evaluate during this clinical study.

Control Product

A known product of similar nature (shampoo) to the Study Product (shampoo), used as a comparator in Controlled evaluation.

Hair Tress

Sample of human hair used in a laboratory setting to evaluate hair products.

 

 

 

1.0 Introduction

This document is a report for a human research study.  This study was conducted according to International Research Services, Inc. research policies and Standard Operating Procedures, U.S. and international standards of Good Clinical Practice (FDA and ICH guidelines) and applicable government regulations.

2.0 Objectives

2.1 Primary Objective

To evaluate the effectiveness of a hair care product in the improvement of hair and scalp condition and appearance after repeated use.

3.0 Study Design

This was an eight-week monadic evaluation of one hair care product’s ability to improve hair and scalp condition and appearance.  All subjects used product at home for eight weeks, returning to the clinic for evaluation after four and eight weeks of repeated use.  Subjects underwent expert clinical visual grading of hair and scalp, instrumental assessments and photography at study visits.  Additionally, subjects tracked hair loss prior to each visit and indicated their perception of the product and its effects via subjective questionnaire completion.  Thirty-one (31) subjects completed study participation. The study also included a single use controlled instrumental evaluation of the product performed on hair tresses to evaluate strength. 

Study visits occurred at Baseline, Week 4 and Week 8.  A detailed outline of study visits appears in Section 7.6 of the protocol (see Appendix I).

3.1 Claims:

Assessment and questionnaire data will be analyzed with particular regard to the following desired key product effects:

1.       Reduces hair loss due to breakage, as determined by  Repeated Grooming Assay results.

2.       Improves strength of hair, as determined by Repeated Grooming Assay results.

3.       Adds body and shine to hair, as determined by expert clinical grading and subjective questionnaire results.

4.       Increases volume and thickness, as determined by expert clinical grading and subjective questionnaire results.

5.       Promotes healthy scalp, as determined by expert clinical grading and subjective questionnaire results.

6.       Reduces split ends, as determined by expert clinical grading and subjective questionnaire results.

7.       Provides deep hydration (to scalp), as determined by Corneometer and subjective questionnaire results.

4.0 Product

All products were provided by the Sponsor and were labeled with appropriate codes and proper use instructions.  Supportive product(s) were provided by IRSI.  Upon receipt, product was logged in and stored in a secure area.  Within one month of issuance of the final signed report, unless otherwise instructed in writing, all test products, used and unused, will be destroyed and disposed of in accordance with IRSI’s SOP.

 

4.1 Product Descriptions

Name

Designation

Formula Number

Date Received

Quantity Received

Study Products

 

 

Pura d'or Hair Loss Prevention Therapy Shampoo

Shampoo

851615006006

3-26-15

70

9-15-15

32

4.2 Product Use Instructions

Sponsor-provided use instructions listed below were explained to subjects and were provided to each subject in their printed Study Instructions (See Appendix I of the Study Protocol which is attached as Appendix I of this Report).

 

Test Product Instructions:

Wet hair, lather in product, leaving on the scalp and hair for 2 minutes. Rinse thoroughly.

Use test product at least three times per week.

Subjects were instructed to use 5 pumps of the product.

Test product use will begin three days after the Baseline visit, after Baseline hair collection is complete per Section 6.4.  For days 0, 1, 2 subjects will continue use of their usual hair care products.

 

5.0 Population

5.1 Sample Size

The sample size of n=30 was requested by the Sponsor.

A total number of 32 subjects were enrolled in the study and 31 completed eight weeks of study participation.

5.2 Inclusion Criteria

1.       Males and Females in good general health, and between ages of 30 and 70 years old, inclusive at enrollment

  1. Subjects with self-perceived  thinning hair and/or hair loss
  2. Subjects will be able to read, understand and willing to sign an ICF, including HIPAA and state requirements, complete a brief personal/medical history
  3. Subjects are willing and able to follow all study directions, attend study visits as scheduled and must be willing to accept the restrictions of the study including but not limited to:

a. Subjects agree to refrain from hair coloring or undergoing any chemical hair treatment(s) for the duration of the study

b. Subjects agree to wash their hair with the test product at least three times per week for the duration of the study

c. Subjects agree to refrain from using any other hair care products, (shampoos, dry shampoos, conditioners, leave in conditioners).

d. Subjects agree to refrain from introducing any new styling products or methods (tools) for the duration of the study.

5.3 Exclusion Criteria

  1. Subjects with over-processed, severely damaged hair.
  2. Subjects with scalp diseases/ infections including fungal infection, psoriasis, ring worm, head lice or severe dry/cracked skin on the scalp.

 

General exclusion criteria:

  1. Subjects participating in any other clinical studies
  2. Subjects having an acute or chronic disease or medical condition, including dermatological problems, which could put the subject at risk in the opinion of the Principal Investigator or compromise study outcomes.  Typical uncontrolled chronic or serious diseases and conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes, morbid obesity, renal impairment, mental illness, drug/alcohol addiction.
  3. Subjects who are unreliable or unlikely to be available for the duration of the study
  4. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.
  5. Immunocompromised subjects
  6. Woman known to be pregnant, lactating or planning to become pregnant within six months.  Subjects who become pregnant during the study must inform the Principal Investigator immediately
  7. Individuals unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function
  8. Employees of IRSI or other testing firms/ laboratories, cosmetic or raw goods manufacturers or suppliers

6.0 Methods

This study was performed in accordance to IRSI final signed clinical study protocol number 3920YS0215 version 2.3 dated July 23, 2015.  A detailed description of study methods is outlined in the attached clinical study protocol (See Appendix I).

 

7.0 Procedure

The three-visit clinical study included one visit for consenting, screening and qualification procedures and Baseline pre-application evaluations, another visit at Week 4 and a final visit at Week 8.  A detailed description of procedures is outlined in the attached clinical study protocol (See Appendix I).

7.1 Procedure Summary Table

Procedures

Baseline

Week 4

Week 8

Study Initiation and Qualification

Informed Consent and Medical History

X

 

 

Inclusion/Exclusion Criteria reviewed

X

 

 

Dispense/ Collect Products

D

 

C

Consumer Perception

Subjective Questionnaire

 

X

X

Clinical Grading

- Hair Body (volume, stiffness, springiness)

- Hair Shine

- Split ends

-Healthy scalp appearance

X

X

X

Instrumentation

Corneometer (scalp)

X

X

X

Photography

Digital Clinical Photography

n=10 sub-group (3 views: Top of head, R profile and Back view)

X

X

X

Hair Loss Measurement

For three days after BL and three days prior to each subsequent visit hair collected by subject and returned to clinic in plastic bag for weight

X

X

X

Repeated Grooming Assay

Hair Strength/ Anti-Breakage

To be completed on hair tresses during study duration.

 

8.0 Concomitant Medications and Products

The use of any hair care products other than those provided, including shampoos, conditioners, dry shampoos, hair oils and powders was prohibited for the duration of the study period starting on Day 3 when test product use began.  For days 0, 1 and 2, subjects were to use their usual hair care products.

If a subject felt that use of a conditioner was required at any point during the study, the subject was instructed to contact the Study Coordinator for instruction on how to proceed.  The subject was permitted to use their own conditioner, but was to record the use on diary each time it was used; the name and brand of the product was also recorded.

Subjects were not allowed to chemically alter their hair in any way during the study, including dying hair, chemically straightening or perming hair.  Subjects were not permitted to introduce any new hair styling products for the duration of the study.  Subjects must have used their styling product / method (tools) for at least two weeks prior to Baseline in order for it to be considered their “usual” products.  Hot styling tools were permitted for use.  Haircuts were allowed.

9.0 Adverse Events

No adverse events were reported during the conduct of this study. 

10.0 Institutional Review Board

IRB review and approval of this study was not requested by the Sponsor.

11.0 Informed Consent

The informed consent process was completed prior to an individual’s involvement in any study related activity.  The process was documented using a written informed consent form (ICF) conforming to FDA 21 CFR 50.25 (See Appendix I Protocol, Section 11.0 and Appendix IV).

After review, two copies of the ICF were signed and dated by the individual and the Principal Investigator or his designee administering the consent.  One original copy was retained by IRSI and the other was given to the individual. 

12.0 Discontinuation of Study

Per protocol, the Sponsor had the option to end the study at eight weeks, or continue on to twelve weeks.  The Sponsor chose to end the study after eight weeks.

13.0 Changes to the Protocol

13.1 Protocol Amendments

One amendment was made to the final study protocol. The signed Protocol Amendment is included in Appendix II. 

  1. The TRI Assay used to assess hair strength was changed from the Diastron Assay to measure “tensile strength” to a Repeated Grooming Assay to evaluate “anti-breakage / hair strength” as well as the claim “reduces hair loss due to breakage”.

13.2 Protocol Deviations

No protocol deviations occurred during the study. 

14.0 Monitoring

The Sponsor did not monitor any portion of this clinical study.

15.0 Recording of Data

All data and information, except electronically recorded data, was recorded on specific paper case report forms (CRFs) as described in the clinical study protocol (See Appendix I Protocol, Appendix III).

16.0 Quality Control and Quality Assurance

This clinical study has been audited by the IRSI Quality Assurance / Quality Control auditor.  The auditor verified study for accuracy, consistency and proper documentation in accordance to IRSI SOPs and practices.   Additionally, accuracy of results reported in the body of this report with respect to the results reported in the data listings and statistical report (See Appendix III).

 

The data listings and database used for statistical analysis was verified against the CRFs. The data listings were verified against the CRFs for 100% of the data, in a randomly selected set of the subjects (25% of the total number of subjects). The statistical report was validated for accuracy and completeness, as well as verifying the correctness of all subject numbers (n) and the analyses performed according to the Statistical Analysis Plan as described in Section 18 of the clinical study protocol.

17.0 Ethics

The study was conducted in accordance with FDA GCP regulations and ICH guidelines in as much as they apply to cosmetic research with the following noted:  This was not an IND / NDA clinical trial. IRSI does not assume any Sponsor obligations as stipulated in FDA GCP and ICH documents. This study is not intended for submission to the FDA.

18.0 Statistical Methods

The planned statistical analysis was performed as outlined in the study protocol for each type of data to be acquired. (See Protocol, Section 18.0) 

The per-protocol (PP) population is defined as the subset of subjects that who complied with the protocol sufficiently to ensure that their data will be likely to exhibit the effects of the treatment.  To be considered a PP subject, a subject could not miss more than one study visit (excluding Baseline and the final visit - Week 8) or be found to be non-compliant with the study protocol at the discretion of the Principal Investigator (PI). 

The PP population was used for statistical analysis at each time point. Statistical significance was set at p≤0.05.

Data Type

Statistical Method

Data Reported

Demographics

Descriptive Statistics

Mean and standard deviation

Min and Max

Frequency (number and percent)

Clinical Grading for Efficacy, Instrumental Evaluation, Hair Loss Evaluation

Descriptive Statistics

Paired T-test (monadic),

Mean and standard deviation

Mean percent improvement from Baseline

Percent of subjects improving

P-value vs. Baseline

Subjective Questionnaire

Descriptive Statistics

Frequency tables (n and %) of each response

Percent of subjects responding favorably.

Repeated Grooming Assay

NA

Analyzed and reported by TRI

 

 

 

19.0 Results

19.1 Tables

Enrollment and demographic information is reported below in Tables 1.0-2.0.  Expert visual grading results are included in Table 3.0, instrumental results are included in Table 4.0, hair loss evaluation results are in Table 5.0, anti-breakage results are in Table 6.0 and subjective questionnaire results are included in Table 7.0.

Table 1.0 Enrollment

Status

n

 

Enrolled

32

 

Discontinued

1

Subject #9 discontinued at Week 4.

Completed Baseline time point

32

 

Completed Week 4 time point

30

Subject #9 and #27 missed the Week 4 visit.

Completed Week 8 time point

31

 

 

Table 2.0 Demographics

Variable

n

Mean ± SD

Min

Max

Age (years)

31

50.22 ± 10.61

31

68

Height (inches)

31

64.83 ± 3.73

59

73

Weight (pounds)

31

176.03 ± 50.83

107

329

 

n

Percent

Sex

31

Female

22

71.0%

Male

9

29.0%

 

n

Percent

Ethnicity

31

Hispanic or Latino

7

22.6%

Not Hispanic or Latino

24

77.4%

 

n

Percent

Race

31

African American or Black

2

6.5%

Asian

1

3.2%

White

23

74.2%

No Response (see Hispanic or Latino above)

5

16.1%

 


 

Table 3.0 Experts Clinical Grader Evaluation – Monadic, Comparison to Baseline

Assessment

Time Point

n

Mean ± SD

Mean Percent Improvement

From BL mean

Percent of Subjects Showing Improvement

From BL

P-Value

TX vs. BL

Springiness (bounciness)

Baseline

31

1.82 ± 0.64

 

 

 

Week 4

30

2.80 ± 0.40

78.66%

86.7%

<0.001*

Week 8

31

3.03 ± 0.34

98.11%

96.8%

<0.001*

Volume (bulk/thickness)

Baseline

31

1.91 ± 0.63

 

 

 

Week 4

30

2.70 ± 0.28

53.44%

76.7%

<0.001*

Week 8

31

3.01 ± 0.32

76.18%

96.8%

<0.001*

Stiffness

(set, not soft)

Baseline

31

1.91 ± 0.64

 

 

 

Week 4

30

2.71 ± 0.38

64.72%

83.3%

<0.001*

Week 8

31

3.29 ± 0.28

110.26%

96.8%

<0.001*

Hair Shine

Baseline

31

1.77 ± 0.61

 

 

 

Week 4

30

2.93 ± 0.36

95.05%

90.0%

<0.001*

Week 8

31

3.25 ± 0.33

117.79%

96.8%

<0.001*

Split Ends

Baseline

31

2.24 ± 0.63

 

 

 

Week 4

30

2.75 ± 0.46

31.94%

70.0%

<0.001*

Week 8

31

3.27 ± 0.31

63.76%

93.5%

<0.001*

Scalp Health

Baseline

31

2.22 ± 0.51

 

 

 

Week 4

30

3.11 ± 0.33

45.77%

93.3%

<0.001*

Week 8

31

3.56 ± 0.33

68.44%

100%

<0.001*

 

Table 3.0 Key

*Indicates a statistically significant improvement compared to baseline, p≤0.05

BL = Baseline, before treatment

TX = Post-treatment time point (Week 4 or Week 8)

SD = Standard Deviation

Grading scales.  Note half points were used as necessary by the expert grader. Increase is indicative of an improvement for all scales listed below.

Springiness (bounciness)

0 = Compressed, no spring or bounce

4 = Airy, weightless appearance, high spring, bounce

Volume (bulk/thickness)

0 = Thin, closely follows shape of skull

4 = Thick, bulky, high elevation from skull and lateral displacement

Stiffness (set, not soft)

0 = Soft, does not hold shape, not resilient

4 = Firm, holds shape, resilient

Hair Shine

0 =  Dull, matte appearance

4 = High gloss, luster

Split Ends

0 = Many split ends, severe splitting

4 = No split ends, no splitting

Scalp Health

0 = Rough, flaking, plaques, cracked and/or reddened appearance

4 = Smooth, intact, even-toned appearance

 


 

Table 4.0 Instrumental Evaluation – Monadic, Comparison to Baseline

Assessment

Time Point

n

Mean ± SD

Mean Percent Improvement

From BL mean

Percent of Subjects Showing Improvement

From BL

P-Value

TX vs. BL

Corneometer

Baseline

31

34.33 ± 21.31

 

 

 

Week 4

30

8.91 ± 14.40

NI

3.3%

<0.001**

Week 8

31

18.37 ± 13.77

NI

16.1%

<0.001**

 

Table 4.0 Key

NI = No improvement

**Indicates a statistically significant worsening compared to baseline, p≤0.05

BL = Baseline, before treatment

TX = Post-treatment time point (Week 4 or Week 8)

SD = Standard Deviation

Corneometer

Instrumental device to measure water content.

Measures in arbitrary units from 0 (no water at all) - 120 (on water)

Increase is indicative of an improvement in hydration of the skin

 

 

Table 5.0 Hair Loss Evaluation – Monadic, Comparison to Baseline

Assessment

Time Point

n

Mean ± SD

Mean Percent Improvement

From BL mean

Percent of Subjects Showing Improvement

From BL

P-Value

TX vs. BL

Hair Loss

Baseline

31

5.90 ± 0.73

 

 

 

Week 4

30

6.07 ± 0.46

NI

30.0%

0.321

Week 8

31

6.12 ± 0.87

NI

22.6%

0.307

 

Table 5.0 Key

NI = No improvement

BL = Baseline, before treatment

TX = Post-treatment time point (Week 4 or Week 8)

SD = Standard Deviation

Hair Loss

Evaluated by measuring (by weight in grams) hair collected by the subjects over a period of three days. 

 

 


 

Table 6.0 Anti-Breakage/Strength Testing – Product Comparison

Assessment

n

Mean ± SD

Broken Fibers

Standard Error

Mean

Percent Reduction in Breakage

Product vs. Control

PT-Value

Product vs. Control

Anti-Breakage

Control Product

8

28.63 ± 5.34

1.89

 

 

Study Product

8

18.88 ± 5.54

1.96

34.05%

0.003T

 

Table 6.0 Key

T Results show a statistically significant lower breakage for Study Product (Pura d’or) as compared to the Control (Clarifying Shampoo).

SD = Standard Deviation

Anti-Breakage

Evaluated by measuring (by count) broken hair fibers collected during Repeat Grooming Assay performed on hair tresses.

 

 

 

Table 7.0 Subjective Questionnaire – Consumer Perception

Question

n

Week 4

Percent Responding Favorably

Response n (%)

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

  1. The product improved the shine of my hair.

30

3 (10.0%)

13 (43.3%)

9 (30.0%)

3 (10.0%)

2 (6.7%)

53.3%

  1. The product improved the body of my hair.

30

4 (13.3%)

15 (50.0%)

8 (26.7%)

3 (10.0%)

0 (0.0%)

63.3%

  1. The product improved the volume of my hair.

30

4 (13.3%)

13 (43.3%)

8 (26.7%)

5 (16.7%)

0 (0.0%)

56.7%

  1. The product improved the thickness of my hair.

30

3 (10.0%)

7 (23.3%)

14 (46.7%)

5 (16.7%)

1 (3.3%)

33.3%

  1. The product improved the hydration of the skin of my scalp.

30

3 (10.0%)

6 (20.0%)

16 (53.3%)

3 (10.0%)

2 (6.7%)

30.0%

  1. The product made my scalp less dry/flaky.

30

2 (6.7%)

5 (16.7%)

19 (63.3%)

4 (13.3%)

0 (0.0%)

23.3%

  1. The product reduced my hair split ends.

30

2 (6.7%)

7 (23.3%)

16 (53.3%)

4 (13.3%)

1 (3.3%)

30.0%

  1. The product reduced my hair breakage.

30

2 (6.7%)

9 (30.0%)

15 (50.0%)

4 (13.3%)

0 (0.0%)

36.7%

  1. The product improved the strength of my hair.

30

2 (6.7%)

9 (30.0%)

17 (56.7%)

2 (6.7%)

0 (0.0%)

36.7%

  1. Overall, the product improved the healthy appearance of my hair.

30

3 (10.0%)

15 (50.0%)

7 (23.3%)

5 (16.7%)

0 (0.0%)

60.0%

  1. Overall, the product improved the healthy appearance of my scalp.

30

2 (6.7%)

8 (26.7%)

16 (53.3%)

4 (13.3%)

0 (0.0%)

33.3%

 

Table 7.0 Key

Bold/ Shaded = the majority of subjects responded favorably, >50%

n = number of subjects

n(%) = number of subjects (percent of subjects)

Responding Favorably = Responding to the question with “Strongly Agree” or “Agree”

Questions were listed in questionnaire exactly as worded above, with response options Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree, listed in that order


 

Table 7.0 Subjective Questionnaire – Consumer Perception

Question

n

Week 8

Percent Responding Favorably

Response n (%)

Strongly Agree

Agree

Neutral

Disagree

Strongly Disagree

  1. The product improved the shine of my hair.

31

3 (9.7%)

14 (45.2%)

9 (29.0%)

5 (16.1%)

0 (0.0%)

54.8%

  1. The product improved the body of my hair.

31

4 (12.9%)

16 (51.6%)

7 (22.6%)

4 (12.9%)

0 (0.0%)

64.5%

  1. The product improved the volume of my hair.

31

4 (12.9%)

15 (48.4%)

8 (25.8%)

4 (12.9%)

0 (0.0%)

61.3%

  1. The product improved the thickness of my hair.

31

5 (16.1%)

8 (25.8%)

11 (35.5%)

7 (22.6%)

0 (0.0%)

41.9%

  1. The product improved the hydration of the skin of my scalp.

31

3 (9.7%)

11 (35.5%)

10 (32.3%)

6 (19.4%)

1 (3.2%)

45.2%

  1. The product made my scalp less dry/flaky.

31

3 (9.7%)

11 (35.5%)

11 (35.5%)

5 (16.1%)

1 (3.2%)

45.2%

  1. The product reduced my hair split ends.

31

4 (12.9%)

11 (35.5%)

11 (35.5%)

3 (9.7%)

2 (6.5%)

48.4%

  1. The product reduced my hair breakage.

31

2 (6.5%)

10 (32.3%)

13 (41.9%)

6 (19.4%)

0 (0.0%)

38.7%

  1. The product improved the strength of my hair.

31

3 (9.7%)

12 (38.7%)

12 (38.7%)

4 (12.9%)

0 (0.0%)

48.4%

  1. Overall, the product improved the healthy appearance of my hair.

31

4 (12.9%)

15 (48.4%)

5 (16.1%)

7 (22.6%)

0 (0.0%)

61.3%

  1. Overall, the product improved the healthy appearance of my scalp.

31

4 (12.9%)

10 (32.3%)

12 (38.7%)

4 (12.9%)

1 (3.2%)

45.2%

 

 

Table 7.0 Key

Bold/ Shaded = the majority of subjects responded favorably, >50%

n = number of subjects

n(%) = number of subjects (percent of subjects)

Responding Favorably = Responding to the question with “Strongly Agree” or “Agree”

Questions were listed in questionnaire exactly as worded above, with response options Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree, listed in that order

 

 

19.2 Discussion

19.2.1  Enrollment and Demographics

A total of 30 male and female subjects between the age of 30 and 70 years old were required to complete study participation.  The study completed with 31 male and female subjects with an age range of 31 to 68 with an average age of 50.22 years old.   The population’s reported ethnicity was 77.4% Non-Hispanic or Latino and 22.6% Hispanic/Latino, and its reported racial diversity was 74.2% White, 16.1% No Response (Hispanic/Latino), 6.5% African American and 3.2% Asian.

19.2.2  Expert Visual Grading

Comparison of mean results from Baseline to those at subsequent visits revealed statistically significant improvements in the appearance of hair springiness, volume, stiffness, shine, split ends and scalp health after four and eight weeks of use.

19.2.3  Instrumental Assessments

Statistically significant worsening (decrease) from Baseline was observed in mean Corneometer results for hairline scalp hydration after four and eight weeks of test product use.

19.2.4  Hair Loss Evaluation

Statistically significant change from Baseline was not observed in mean hair loss at either the Week 4 or Week 8 visits.

19.2.5  Anti-Breakage / Strength Testing

The Repeated Grooming Assay performed by TRI showed a statistically significant difference between hair breakage rates between the control and test product results.  These results indicate hair treated with the test product showed a significantly less amount of breakage and in turn less hair loss from tress, than hair treated with the control product, indicating an improvement in hair strength.  The test product statistically significantly outperformed the control product in regards to hair breakage rate, and showed a 34.05% reduction in hair breakage when compared to the control shampoo.

19.2.6  Subjective Questionnaire

After four and eight weeks of use, a majority of subjects (>50%) responded favorably (“Strongly Agree” or “Agree”) to “The product improved the shine of my hair”, “The product improved the body of my hair”, “The product improved the volume of my hair” and “Overall, the product improved the healthy appearance of my hair”.

20.0 Conclusion

In conclusion, under the conditions of this study, use of Pura d'or Hair Loss Prevention Therapy Shampoo #851615006006 led tosignificant improvements in hair and scalp appearance and in hair strength, as evidenced by results from expert clinical grading, anti-breakage testing and subjective questionnaire results. 

Expert clinical grading revealed statistically significant improvements in the appearance hair springiness, volume, stiffness, shine, split ends and scalp health after four and eight weeks of use. 

Anti-breakage testing showed significant less breakage in hair treated with test product versus that treated with control product.  The test product was found to reduce breakage by 34.05% after a single use.

Subjective questionnaire results revealed that the majority of subjects believed that test product use resulted in improvements in hair shine, body, volume and overall healthy appearanceafter four and eight weeks of use.