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. 

 

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

 

 

 

List of Abbreviations

 

 

Definitions

 

 

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

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

2. Subjects with self-perceived thinning hair and/or hair loss
3. Subjects will be able to read, understand and willing to sign an ICF, including HIPAA and state requirements, complete a brief personal/medical history
4. 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:

3. Subjects participating in any other clinical studies
4. 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.
5. Subjects who are unreliable or unlikely to be available for the duration of the study
6. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.
7. Immunocompromised subjects
8. 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
9. Individuals unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function
10. 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

 

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.

 

 

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

 

Table 2.0 Demographics

 

 

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

 

 

 

Table 4.0 Instrumental Evaluation – Monadic, Comparison to Baseline

 

 

 

Table 5.0 Hair Loss Evaluation – Monadic, Comparison to Baseline

 

 

 

 

Table 6.0 Anti-Breakage/Strength Testing – Product Comparison

 

 

 

 

Table 7.0 Subjective Questionnaire – Consumer Perception

 

 

Table 7.0 Subjective Questionnaire – Consumer Perception

 

 

 

 

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.