International Research Services, Inc.	Clinical Research Report
A FOUR-WEEK, MONADIC, OPEN-LABEL STUDY OF ONE HAIR CARE PRODUCT REGIMEN
Protocol Number:	3762REV1013
Sponsor:	Reviv3 Procare 1601 Dove Street, Suite #450 Newport Beach, CA 92660
Issued To:	Thomas Curzio President & Co-founder Phone:  909.944.9068 E-Mail:  [email protected]		Debbie Zimmerman Senior Vice President, Account Director Davis Elen Advertising 865 South Figueroa Street Los Angeles, CA 90017 Phone:  213.688.7236 Fax: 213.688.7225 E-Mail:[email protected]
Date of Issue:	January 30, 2013
Study Site:	International Research Services, Inc. 222 Grace Church Street Port Chester, NY 10573 Phone: 914.937.6500 Fax:  914.937.8067   Stephen R. Schwartz IRSI President, CEO E-Mail:  [email protected]
Principal Investigator:	Robert J. Frumento IRSI VP Clinical and Corporate Operations E-Mail:  [email protected]
Study Coordinator:	Cathy Audia Study Coordinator E-Mail:  [email protected]
Study Schedule	Initiation (Visit 1)	Baseline			11/19/2013
	Completion (Visit 2)	Week 4			12/20/2013
Products:	Reviv3 Procare 3-Part System Shampoo (cleanser) Conditioner (moisturizer) Spray Treatment			C/T = ES43-041A C/T = ES44-032A C/T = ES44-032D

 

Study Summary
Title	A Four-Week, Monadic, Open-Label Study of One Hair Care Product Regimen
Protocol Number	3762REV1013
Sponsor	Reviv3 Procare
Methodology	Monadic, open label
Objective	To determine the efficacy of a three-product hair care regimen to improve scalp condition as well as the appearance and strength of hair when used by a panel of male and female subjects for four weeks.
Number of Subjects	30 to complete, target enrollment 33
Target Population	30 Female and male subjects (approximately 50% each), multi-ethnic panel, in good general health, age 25-65 years, with widow’s peak hair line or receding hairline, and Fitzpatrick Skin Types I-V.
Duration	4 week treatment
Study Products	Name		Formula Number
	Reviv3 Procare 3-Part System Shampoo (cleanser) Conditioner (moisturizer) Spray Treatment		C/T = ES43-041A C/T = ES44-032A C/T = ES44-032D
Statistical Methodology	Descriptive statistics, monadic analysis using paired t-test to compare to baseline, All final statistical analyses will be performed on the PP population, significance set at p≤0.05.
Study Schedule	Initiation:	Baseline		November 19, 2013
	Completion:	Week 4		December 20, 2013
	Final Topline:	Week 4		January 3, 2014
	Photographs:			January 24, 2014
	Draft Final Report:			January 24, 2014
Summary	This was a monadic, open label evaluation of the attributes one hair care regimen and its effects after four weeks of use.  A study panel of 34 subjects was enrolled and 33 completed study participation.  Each subject applied the test product to their hair and scalp according to Sponsor instructions for the entire four-week study period and underwent visual, instrumental assessments and photography at the Baseline and Week 4 visits.  A subjective questionnaire was also completed by all subjects at their Week 4 visit. Under the conditions of this study, Reviv-3 Procare 3-Part System was shown to improve certain aspects of scalp and hair condition and the appearance of hair under normal use conditions.  Consumer perception of product was positive regarding the product regimen’s ability to improve scalp and hair cleanliness, improve hair texture and body, and to reduce hair shedding.  81.8% Of subjects indicated that they would use the product again, and 78.8% would recommend it to a friend or family member.  See #20.0, Discussion, and 21.0, 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: [email protected]	Signature and Date:
Principal Investigator:	Robert J. Frumento IRSI VP Clinical and Corporate Operations E-Mail:  [email protected]	Signature and Date:
IRSI President, CEO:	Stephen R. Schwartz IRSI President, CEO E-Mail:  [email protected]	Signature and Date:

 

Table of Contents

1.0        Introduction. 6

2.0        Objectives. 6

3.0        Study Design. 6

4.0        Product 7

5.0        Population. 7

6.0        Methods. 8

7.0        Procedure. 9

8.0        Concomitant Medications and Products. 9

9.0        Adverse Events. 9

10.0      Institutional Review Board. 10

11.0      Informed Consent 10

12.0      Discontinuation of Study. 10

13.0      Changes to the Protocol 10

14.0      Monitoring. 10

15.0      Recording of Data. 10

16.0      Quality Control and Quality Assurance. 10

17.0      Ethics. 11

18.0      Statistical Methods. 11

19.0      Results. 11

Table 3.0 Expert Clinical Grader Evaluation – Monadic, comparison to Baseline  13

20.0      Discussion. 22

21.0      Conclusion. 22

 

Appendices

Appendix I	Protocol and Deviations
Appendix II	Statistical Report
Appendix III	AE Forms

 

 

List of Abbreviations

 

 

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

1.0    

2.0    

2.1   Primary Objective

To assess the ability of one hair care regimen, including three products, to improve scalp and hair condition.

2.2   Secondary Objective

To assess the ability of one hair care regimen, including three products, to improve the appearance of hair under normal use conditions.

3.0  Study Design

This was a four week, monadic, open-label study of one hair care product regimen comprised of three products. The intended subject cohort was no less than 30 adult males and females, comprised of approximately 50% of each.  All subjects received the test regimen for application per Sponsor-supplied instructions during the four week study period.  At study visits, subjects underwent instrumental assessments of their scalp and hair, visual grading of certain attributes of their scalp and hair and photography.  They also responded to subjective questionnaires regarding the test product regimen and its effects.  Visual analogue scales (VAS) or ordinal scales were used for all visual grading.  Instrumental assessments included Moisture Meter, Vapo Meter, SIAscope, Cutometer, pH Meter and Dia-stron Assay (TRI Princeton).  Visits took place at Baseline (BL) and Week 4.

3.0    

3.1   Claims

Data was collected and analyzed with specific regard to the following proposed product claims:

1.    Improves hydration of scalp, as assessed by Moisture Meter, subjective questionnaire.

2.    Reduces water loss of scalp, as assessed by Vapo Meter.

3.    Improves firmness/elasticity of scalp, as assessed by Cutometer.

4.    Improves scalp hemoglobin (i.e. oxygenation) and collagen, as assessed by SIA scope.

5.    Improves cleanliness of scalp, as assessed by subjective questionnaire.

6.    Improves the appearance of hair shine, radiance, fullness (volume), luster and softness, as assessed by visual grading and subjective questionnaire.

7.    Reduces the appearance of dry/flaky scalp, as assessed by subjective questionnaire.

8.    Maintains vibrancy of and evens/blends hair color (color-treated hair), as assessed by subjective questionnaire.

9.    Improves hair strength, reduces breakage, as assessed by TRI assay.

10. Reduces hair frizz, as assessed by visual grading and subjective questionnaire.

11. Helps to remove dirt/oil from hair, as assessed by subjective questionnaire.

12. Improves scalp skin pH, as assessed by pH meter.

13. Reduction of hair loss in shower or hair brush, as assessed by subjective questionnaire.

4.0  Product

All products were provided by the Sponsor and were labeled with appropriate codes and proper use instructions.  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.

4.0    

4.1   Product Descriptions

Name	Designation	Formula Number	Date Received	Quantity Received	Quantity Unused
Study Product
Reviv3 Procare 3-Part System:
Shampoo (Cleanser)	NA	C/T = ES43-041A	11/18/13	44 sets	9
Conditioner (Moisturizer)	NA	C/T = ES44-032A			9
Spray Treatment	NA	C/T = ES44-032D			9

4.2   Product Use Instructions

Sponsor-provided use instructions were verbally explained to subjects and were provided to each subject in their printed Study Instructions ((See Appendix I Protocol, Appendix I)). 

Shampoo Directions:

Apply shampoo to wet hair and lather. Allow to remain on hair and scalp for 1 minute, rinse well. Repeat if needed, avoid contact with eyes, and follow with conditioner. Use daily.

Conditioner Directions:

After shampooing, distribute a generous amount of conditioner onto scalp and throughout the hair, leave in on 1-3 minutes, rinse well. Follow with treatment. Use daily.

Spray Treatment Directions:

On towel-dried hair, apply treatment to entire scalp by spraying close to scalp skin, distribute through hair and scalp with fingertips or a wide toothcomb, do not rinse. Use daily. May cause temporary redness on the skin, this is normal.

5.0  Population

5.0    

5.1   Sample Size

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

·        34 subjects were enrolled in the study and 33 completed.

·        Entrance criteria for the study were as follows.

5.2   Inclusion Criteria

1. Males and Females (approximately 50% of each), in good general health.

2. Between ages of 25 and 65 years old, inclusive at enrollment

3. Multi-ethnic panel (Asian, Caucasian and Hispanic only), with at least one subject of each ethnicity.

4. At least five subjects with dyed hair (self-applied or professional)

5. Able to read, understand and willing to follow study instructions, complete a brief personal/medical history and sign an informed consent document

6. Subjects with widow’s peak or receding hairline (must have sufficient hairless scalp area to apply measurement probes).

7. Willing to forego use of all hair products other than study products, including shampoos, conditioners, styling products, cleansers and medicated creams, during the washout and study periods.  Subjects are allowed to style their hair as they normally would without the use of products.

8. Subjects with Fitzpatrick Skin type I–V

9. Willing to arrive at the testing center for scheduled study visits having not used any hair styling products on the day of each visit

10. Willing to forego all swimming during study period

5.3   Exclusion Criteria

1.    Subjects currently using any hair thickening or hair growth treatments (ex. Rogaine)

2.    Subjects who are participating in any other clinical studies

3.    Females who started Hormone Replacement Therapy within the last three months preceding the screening visit

4.    Females under oral contraception for less than three months before the screening visit or who has changed her contraceptive method within the three months before the screening visit or plans to modify her contraception treatment within the duration of the study

5.    Subjects who are required to spend excessive time in the sun (i.e. lifeguards and other outdoor workers, vacationers)

 

General exclusion criteria:

6.       Subjects having an underlying disease, surgical or medical condition, which could put him/her at risk in the opinion of the Principal Investigator (PI): uncontrolled chronic or serious diseases which would normally prevent participation in any clinical trial, such as a cancer, AIDS, diabetes, obesity, renal impairment, mental illness

7.       Drug addicts, alcoholics

8.       Subjects who have known allergies to any personal care products (self-reported)

9.       Immunocompromised subjects

10.   Females known to be pregnant, nursing or planning to become pregnant within six months.  Subjects who become pregnant during the study must inform the Principal Investigator immediately

11.   Individuals unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function

12.   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 3762REV1013 version 3.0 dated November 15, 2013.  A detailed description of study methods is outlined in the attached clinical study protocol (See Appendix I).

7.0  Procedure

This was a two-visit clinical study, Baseline and Week 4.  Procedures occurred at each visit as detailed in 7.1 below.  A detailed description of procedures is outlined in the attached clinical study protocol (See Appendix I).

6.0    

7.0    

7.1   Procedure Summary Table

Procedure		Baseline	WEEK 4
Consent and medical history		X
Inclusion/Exclusion criteria reviewed		X
Dispense (D) / Collect (C) Products Diary		D	C
Diary review, product weights			X
Expert Grader Assessments for Efficacy	Hair shine density Hair volume Hair shine/radiance/luster Hair softness Hair frizz	X	X
Instrumental	Moisture Meter (hydration) VapoMeter (TEWL) Cutometer pH Meter SIAscope (hemoglobin, collagen)	X	X
Photography	Digital photography (specify if sub-group, list analysis if applicable )	X	X
Subjective Questionnaire			X
Dia-stron  Assay (TRI Princeton, hair strength)		NA in-vitro

 

8.0  Concomitant Medications and Products

The use of any topical hair/skin treatment products (other than those assigned during the study) on the hair or scalp, respectively, was prohibited during the study.  This included, but was not limited to shampoos, conditioners, styling products, cleansers and medicated creams.  Continued use of all other personal care products and cosmetics regularly being used by subjects at time of enrollment into the study was allowed.  However, use of any new personal care products and cosmetics was prohibited until study completion. 

9.0  Adverse Events

Two adverse events were recorded during this study.

Subject #37 experienced a moderate burning sensation on the skin of the back and chest after use of the spray product, which she described as feeling like a “bad sunburn”.  Sensation lasted approximately one hour, then resolved after subject applied moisturizer.  Subject discontinued use of spray product, but continued use of shampoo and conditioner products, uninterrupted.  The product-relatedness of this AE was judged to be “probable” by the Principal Investigator.

Subject # 6 reported a “bright red rash on shoulders, back, chest and stomach”.

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

The study was not completed on schedule as per the clinical study protocol due to an insufficient number of subjects enrolled at baseline (see 13.2 Protocol deviations below).

13.0          Changes to the Protocol

8.0      

9.0      

10.0      

11.0      

12.0      

13.0      

13.1     Protocol Amendments

No protocol amendments were executed during this study.

13.2     Protocol Deviations

Three protocol deviations were recorded during this study.

Deviation 1: (Major) Insufficient number of subjects were enrolled at baseline. An additional 6 subjects were recruited and study schedule extended.

Deviation 2: (Major) The pH meter malfunctioned at Week 4 resulting in data capture for only 17 out of 33 subjects.

Deviation 3:  (Minor) AE reported late (>5 business days) as per protocol requirements.

14.0          Monitoring

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

15.0          Recording of Data

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

16.0          Quality Control and Quality Assurance

This clinical study has been audited by the IRSI Quality Assurance / Quality Control auditor.  The auditor verified the 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 has been verified relative to the results reported in the data listings and statistical report (See Appendix II).

 

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 statistical analysis performed is outlined below for each type of data acquired. 

The per protocol (PP) population is defined as the subset of subjects who complied with the protocol sufficiently to ensure that their data would be likely to exhibit the effects of the treatment.  To be considered a PP subject, a subject could not miss any study visit or be found non-compliant with the study protocol, at the discretion of the Principal Investigator. 

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 Frequency (number and percent)
Clinical Grading Assessments for Efficacy Instrumental Assessments	Descriptive Statistics Paired T-test (monadic)	Mean and standard deviation Mean difference from Baseline Mean percent improvement from Baseline Percent of subjects improving P-value vs. Baseline
Subjective Questionnaire	Descriptive Statistics	Frequency tables (n and %) of each response Frequency table of open ended responses

19.0          Results

14.0      

15.0      

16.0      

17.0      

18.0      

19.0      

19.1     Tables

Enrollment and demographic information is reported below in Tables 1.0-2.0.  Visual and instrumental assessment results are included in Tables 3.0-4.0 and 6.0-10.0 and in Figures 1-5.  Subjective questionnaire results are detailed in Table 5.0.

20.0          Table 1.0 Enrollment

Status	n
Enrolled	34
Discontinued	1
Completed Time Point	33

 

21.0          Table 2.0 Demographics

Variable	n	Mean ± SD	Min	Max
Age (years)	33	56.09 ± 6.18	34	65
Height (inches)	33	66.63 ± 4.03	60.0	75.0
Weight (pounds)	33	190.21 ± 59.18	110	380
			n	Percent
Sex	33	Male	16	48.5%
		Female	17	51.5%
			n	Percent
Race	33	Caucasian	26	78.8%
		Asian	5	15.2%
		Hispanic	2	6.1%
			n	Percent
Fitzpatrick Skin Type	33	Skin Type I	1	3.0%
		Skin Type II	4	12.1%
		Skin Type III	13	39.4%
		Skin Type IV	15	45.5%
			n	Percent
Dyed Hair	33	Yes	15	45.5%
		No	18	54.5%

 

Table 3.0 Expert 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
Hair Thickness	Baseline	33	6.71 ± 2.31
	Week 4	33	5.17 ± 2.26	14.55%	75.8%	<0.001*
Hair Density	Baseline	33	6.73 ± 2.30
	Week 4	33	5.37 ± 2.29	13.76%	72.7%	<0.001*
Hair Volume	Baseline	33	6.87 ± 2.03
	Week 4	33	5.62 ± 2.43	13.97%	69.7%	0.004
Hair Shine/ Radiance/ Luster	Baseline	33	6.54 ± 2.07
	Week 4	33	5.90 ± 1.91	NI	57.6%	0.148
Hair Softness	Baseline	33	3.88 ± 2.57
	Week 4	33	3.25 ± 1.98	NI	57.6%	0.193
Hair Frizz	Baseline	33	6.60 ± 2.36
	Week 4	33	7.05 ± 2.35	NI	36.4%	0.344

NI= No improvement

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

 

22.0          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
pH Meter		Baseline	17	5.84 ± 3.50
		Week 4	17	6.55 ± 1.72	81.51%		0.508
Moisture Meter:  Hydration		Baseline	27^	36.80 ± 24.63
		Week 4	27^	31.83 ± 17.20	18.17%	40.7%	0.243
Vapo Meter: TEWL		Baseline	27^	18.06 ± 9.59
		Week 4	27^	16.45 ± 9.03	NI	63.0%	0.378
Cutometer	Firmness R0 (Uf)	Baseline	31^	0.06 ± 0.03
		Week 4	31^	0.11 ± 0.03	NI	12.9%	<0.001**
	Elasticity R5 (Ur/Ue)	Baseline	32^	0.63 ± 0.50
		Week 4	32^	0.56 ± 0.30	35.61%	56.3%	0.460
SIAScope:	Hemoglobin	Baseline	33	87.46 ± 15.88
		Week 4	33	117.46 ± 15.88	25.43%	97.0%	<0.001*
	Collagen	Baseline	33	168.25 ± 16.49
		Week 4	33	177.71 ± 24.61	6.22%	69.7%	0.042*

NI= No improvement

^Outliers were removed from analysis.

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

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

23.0          Table 5.0 Consumer Perception – Subjective Questionnaire

Question	Week 4
	n		Response n (%)
			Strongly Agree	Agree				Neutral		Disagree		Strongly Disagree	Responding Favorably
1. Does your scalp feel less dry than usual?	33		1 (3.0%)	12 (36.4%)				15 (45.5%)		5 (15.2%)		0 (0.0%)	13 (39.3%)
2. Does your scalp move more freely when you massage it?	33		1 (3.0%)	13 (39.4%)				17 (51.5%)		2 (6.1%)		0 (0.0%)	14 (42.4%)
3. Does your scalp appear to be cleaner?	33		4 (12.1%)	21 (63.6%)				6 (18.2%)		2 (6.1%)		0 (0.0%)	25 (75.7%)
4. Did you notice an improvement in your hairs’ volume?	33		5 (15.2%)	9 (27.3%)				14 (42.4%)		5 (15.2%)		0 (0.0%)	14 (42.4%)
5. Did you notice an improvement in the shine of your hair?	33		2 (6.1%)	14 (42.4%)				11 (33.3%)		6 (18.2%)		0 (0.0%)	16 (48.4%)
6. Did you notice an improvement in the texture of your hair?	33		7 (21.2%)	15 (45.5%)				7 (21.2%)		4 (12.1%)		0 (0.0%)	22 (66.6%)
7. Did you notice an improvement in your hairs’ body?	33		10 (30.3%)	10 (30.3%)				10 (30.3%)		3 (9.1%)		0 (0.0%)	20 (60.6%)
8. Is your scalp less dry/flaky?	33		3 (9.1%)	13 (39.4%)				13 (39.4%)		4 (12.1%)		0 (0.0%)	16 (48.4%)
9. If your hair is colored, did your color remain bright and vibrant?	15^		1 (6.7%)	7 (46.7%)				5 (33.3%)		2 (13.3%)		0 (0.0%)	8 (53.3%)
10. Did the Products reduce hair frizz?	33		1 (3.0%)	14 (42.4%)				13 (39.4%)		4 (12.1%)		1 (3.0%)	15 (45.4%)
11. Were dirt, oil and styling products effectively removed leaving hair clean?	33		4 (12.1%)	23 (69.7%)				5 (15.2%)		1 (3.0%)		0 (0.0%)	27 (81.8%)
12. Did the products reduce the amount of hair shedding? Less hair in shower or hairbrush	33		3 (9.1%)	16 (48.5%)				12 (36.4%)		4 (6.1%)		0 (0.0%)	19 (57.5%)
			Yes		No
13. Have you used a similar product of another brand?		33	5 (15.2%)		28 (84.8%)
			Excellent			Good			Satisfactory		Unsatisfactory
14. How would you rate your experience of using our products?		33	10 (30.3%)			14 (42.4%)			6 (18.2%)		3 (9.1%)

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

^ Only subjects with dyed hair included in this analysis.

Table 5.0 Consumer Perception – Subjective Questionnaire (continued)

Question	Week 4
	n	Response n (%)
		Yes	No						Responding Favorably
15. Would you use our product again?	33	27 (81.8%)	6 (18.2%)						27 (81.8%)
16. Would you recommend our products to friends or relatives?	33	26 (78.8%)	7 (21.2%)						26 (78.8%)
		TV Advertising		Magazine Advertising			Professional Hairdresser Recommendation	Friends or Family
17. What influences your buying decision?	33	14 (42.4%)		8 (24.2%)			13 (39.4%)	15 (46.9%)
18. Optional: Additional Comments for each of the products:	7	Irritation			1 Subject
					Subject 6:  Conditioner caused bright red rash on shoulders, back, chest and stomach. I had to take off shower head and bend over to rinse off product so that it did not run over body. (See AE)
		Positive Response			4 Subjects
					Subject 37:  I am very pleased because it seems I have some new hair growth.
					Subject 24:  Conditioner has cool, tingling sensation
					Subject 26: I liked the tea tree oil in the shampoo (assuming that’s what it is) – the tingly sensation and the fresh minty scent. And the conditioner did a nice job on my hair
					Subject 36: …otherwise I saw results immediately!
		Negative Response			2 Subjects:
					Subject 23: Did not notice any change where I have thinning.
					Subject 36:  I thought the conditioner could have been a bit deeper….
		Fragrance			1 Subject – Not pleasant
					Subject 8:  Smell of hair spray not very pleasant
					2 Subjects - Medicinal
					Subject 37:  The Shampoo had a slight medicinal smell.
					Subject 24:  Medicine-like odor to the products
					1 Subject – Liked it
					Subject 26: I liked the tea tree oil in the shampoo (assuming that’s what it is) – the tingley sensation and the fresh minty scent

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

24.0          Table 6.0 Repeated Grooming (TRI Princeton Assay)

Treatment	Number	Mean	Std Dev	Std Err Mean	Sig.
Untreated	8	83.75	6.86	2.43	A
Treated	8	21.00	7.35	2.60		B

Levels not connected by same letter are significantly different.

 

Figure 1.0 Results for Anti-Breakage after 10,000 Strokes

 

Summary:

Results showed that the treatment provides a significant reduction in broken fibers in this test approximately 75% compared to the control, untreated, group.

 

 

25.0          Table 7.0 Tensile Results: Treatment vs. Modulus (TRI Princeton Assay)

Treatment	Number	Mean	Std Dev	Std Err Mean	Sig.
treated	50	3.0446e+9	176290692	24931269	A
untreated	50	3.1606e+9	222677675	31491379		B

Levels not connected by same letter are significantly different.

 

Figure 2: Results of Treatment vs. Modulus

 

26.0          Table 8.0 Tensile Results: Treatment vs. Plateau Stress (TRI Princeton Assay)

Treatment	Number	Mean	Std Dev	Std Err Mean	Sig.
treated	50	0.011178	0.000479	6.77e-5	A
untreated	50	0.012072	0.000447	6.32e-5		B

Levels not connected by same letter are significantly different.

 

Figure 3: Results of Treatment vs. Plateau Stress

 

27.0          Table 9.0 Tensile Results: Treatment vs. Break Extension (TRI Princeton Assay)

Treatment	Number	Mean	Std Dev	Std Err Mean	Sig.
treated	50	48.5768	4.06038	0.57422	A
untreated	50	48.6400	6.03403	0.85334	A

Levels not connected by same letter are significantly different.

 

Figure 4: Results of Treatment vs. Break Extension

28.0          Table 10.0 Tensile Results: Treatment vs. Break Stress (TRI Princeton Assay)

Treatment	Number	Mean	Std Dev	Std Err Mean	Sig.
treated	50	0.021066	0.001638	0.00023	A
untreated	50	0.021472	0.001785	0.00025	A

Levels not connected by same letter are significantly different.

 

Figure 5: Results of Treatment vs. Break Stress

 

29.0          Discussion

19.2     Enrollment and Demographics

Enrollment of 34 subjects was achieved in two enrollment groups.  The first enrolled 28 subjects on December 18th^th, 2013 and the second enrolled six subjects on December 20^th, 2013.  A total of 30 subjects between the ages of 25 and 65 years, inclusive, were required to complete study participation.  The study completed with 33 subjects with an age range of 34-65 years, with an average age of 56.09 years.  The population was comprised of 48.5% males and 51.5% females, and the population was 78.8% Caucasian, 15.2% Asian and 6.1% Hispanic.

19.3     Expert Visual Grading

Statistically significant improvements from Baseline to the Week 4 visit were seen in the mean scores for appearance of hair thickness, density and volume.  No improvement was seen during the same time period in the mean scores for appearance of hair shine/radiance/luster, softness or frizz.

19.4     Instrumental Assessment

Statistically significant improvement from Baseline to the Week 4 visit was seen in the mean SIAscope score for collagen, and hemoglobin while significant worsening was observed in mean Cutometer score for firmness during the same time period.  Though the majority of subjects experienced an improvement from Baseline to the Week 4 visit in their individual scores for Vapo Meter: trans-epidermal water loss (TEWL) and Cutometer: elasticity, the change in mean scores for these attributes was not statistically significant.  An 81.51% improvement in mean pH from Baseline to Week 4 also was not found to be statistically significant.

19.5     TRI Assay

The difference between treated and untreated hair in fiber breakage after a given amount of grooming was found to be statistically significant, with the treated hair showing a mean of 21.00 broken fibers after 10,000 strokes versus a mean of 83.75 broken fibers after 10,000 strokes in the untreated hair.  The results of the tensile test show that the treatment had a statistically significant decrease in hair modulus and plateau stress from the untreated sample (these regions are generally associated with the alpha-helical spring of the hair), but did not show a statistically significant change in break extension or break stress.  No other statistically significant results were observed.

19.6     Subjective Questionnaire

The majority of subjects responded positively (“Strongly Agree” or “Agree”) to the questions “Does your scalp appear to be cleaner?”, “Did you notice an improvement in texture of your hair?”, “Did you notice an improvement in your hair’s body?”, “Were dirt, oil, and styling products effectively removed leaving hair clean?”, and “Did products reduce the amount of hair shedding?”.  Further, 72.7% of subjects rated their experience with the test products either “good” or “excellent”, 81.8% would use the products again and 78.8% would recommend the products to a friend or relative.

30.0          Conclusion

In conclusion, under the conditions of this clinical trial, Reviv-3 Procare 3-Part System was shown to improve certain aspects of scalp and hair condition and the appearance of hair under normal use conditions including significant improvements up to 14% after four weeks of use in hair thickness, density and volume as well as a 25% improvement in hemoglobin content and 6% improvement in collagen content.  When hair fibers were tested for strength post treatment results showed that the treatment provides a significant reduction in broken fibers in this test approximately 75% compared to the control, untreated, group.  

Consumer perception of product was positive regarding the product regimen’s ability to improve scalp and hair cleanliness, improve hair texture and body, and to reduce hair shedding.  81.8% of subjects indicated that they would use the product again, and 78.8% would recommend it to a friend or family member.

 

31.0          Appendix I

 

Protocol

and  Protocol Deviations

32.0          Appendix II

 

Statistical Report