Study on the Efficacy of juliArt Hair Growth ECHO System

Contract no.: HK109-104
Contract period: 15 January 2021 to 30 November 2022
Executing institution: Department of Applied Cosmetology (Master Program), Hungkuang University
Collaborator: MacroHI Co., Ltd
Principal investigator: Department of Applied Cosmetology (Master Program)/Center for General Education
Professor Hsiao-Fen Wang
Co-investigator: Department of Applied Cosmetology (Master Program)
Chair Professor Kuang-Hway Yih
July 2022

I. Study background and aims

After the applicant’s human study was approved by the (research ethics) committee TH-IRB-0021-0006), 18 males aged 20-45 years were recruited. The patented test method of MacroHI Co., Ltd and Scalp X scalp quantitation analysis system were used to test the efficacy of the products. The hair revitalization results of 4 products, juliArt exfoliating liquid shampoo, juliArt CISPER hair revitalizing shampoo, juliArt CISPER hair revitalizing scalp restorer, and juliArt CISPER hair revitalizing serum were assessed.

II. Materials and methods

Devices and equipment
Scalp X scalp quantitative analysis system
Experimental methods
Inclusion criteria:
1. Males aged 20 to 45 years.
2. Assessed to have androgenic alopecia by a physician (androgenic alopecia is divided into 7 stages, and patients with the first 4 stages are expected to be enrolled)
3. Subjects that were willing to sign the informed consent form.
4. The enrollment site was Hungkuang University.

Exclusion criteria:
1. Currently receiving scalp drug treatment according to medical order.
2. Irregular lifestyle habits: such as pulling all-nighters, binge drinking, smoking, and excessive exposure to sunlight.
3. Subjects who participated in efficacy studies for other products during the studies.
4. Subjects diagnosed with atopic constitution or allergic scalp by the physician.
5. Students taught by the principal investigator.
Testing site and environment:
Country: Republic of China
Climate: Subtropical
Study period: Outdoor temperature of 10℃-35℃ according to the announcement by the Central Weather Bureau of Taiwan.
City/region: Taichung City, NB108 Cosmetic Functionality Evaluation and Testing Laboratory, Hungkuang University
Experimental environment: Hungkuang University
NB108 Laboratory. The laboratory had a constant temperature and constant humidity indoor environment with relative humidity of 60 ± 5% and room temperature of 20 ± 1℃.
Device test condition and methods:
1. Brief description of proposal background and domestic and overseas technical evaluation: Referring to the test method of Olsen et al., minoxidil that was approved by the US FDA was used for the study (conclusion: more than 300 people underwent a 6-month double-blind study, with the control group using placebo and the experimental group using 5% of this product. The results showed that the product was the most effective in androgenetic alopecia in subjects aged 18-41 years). After examining the data in Taiwan, there were clear experimental conditions and specifications to be carried out for health food certification. However, there were no relevant experimental requirements and specifications for hair growth and hair care products. Therefore, the FDA-certified product experimental method could be used for this proposal. As there are many subjects in this study, a double-blind and control group (placebo) study could be simultaneously conducted. This was a prospective proposal, of which “effective” and “actual hair growth” were confirmed as the primary objectives. In addition, as the treatment period was long and the study fees required were expensive, there was no double blinding, and no control group and the number of subjects was 18 in this study design.

2. Skin and hair measurement: The patented test method of MacroHI Co., Ltd and Scalp X scalp quantitation analysis system were used to record hair density and hair shaft diameter and affected areas were photographed (Republic of China patent application, patent no.: I562757), and a camera was used to record the scalp photographs of the subjects. The test results were compared to the control group based on the data analyzed and calculated by the instrument, and the standard deviation, mean value, and improvement ratio were further calculated.

The test items are as follows:
1. Total hair density: The number of hairs in the subject’s head (3 measurement areas, left, right, and top) were measured before the product is used (self-controlled). The higher the value, the greater the total hair density.
  ※Improvement rate% = (absolute value before use-absolute value after use)/absolute value before use-
  *100% (Li, 2014)
2. Hair shaft diameter: The hairs in the subject’s head (3 measurement areas, left, right, and top) were measured before the product is used (self-controlled). The higher the value, the greater the hair shaft diameter.
  ※Improvement rate% = (absolute value before use-absolute value after use)/absolute value before use-
  *100% (Li, 2014)
3. Thin hair density ratio: The hairs in the subject’s head (3 measurement areas, left, right, and top) were measured before the product is used (self-controlled). The lower the value, the lower the thin hair density ratio.
  
  ※Improvement rate% = (absolute value before use-absolute value after use)/absolute value before use-
  *100% (Li, 2014)
  
  Experiment design and procedure:
  1. Before the efficacy study, a patch test was first performed in which the investigational product and the blank control were applied on skin at the medial arm. The subject was observed for 24 hours to confirm that no allergy was present and subsequent tests could be carried out. Subjects would wash their heads one night before the test. On the next day, the subject would enter the NB108 laboratory and rested for 10 minutes before the experiment was carried out.
  2. Long-term efficacy experiment: The ECHO maintenance procedure of MacroHI Co., Ltd was used for home care in every subject (Figure 1), and the head was washed one night before testing. The subjects returned to the laboratory and scalp hair testing was performed in the laboratory 5 times (before use and 30, 60, 90, and 180 days after use). The patented test method of MacroHI Co., Ltd and Scalp X scalp quantitation analysis system was used to measure total hair density, hair shaft diameter, and thin hair density ratio (test area: affected scalp in the subject). The time required for each experiment was 40 minutes.
  In Figure translation: juliArt exfoliating liquid shampoo, 1-2 times a week. juliArt CISPER hair revitalizing shampoo (oily scalp), once a day. juliArt CISPER hair revitalizing scalp restorer (oily scalp), once a day. juliArt CISPER hair revitalizing serum, once a day
  
  Figure 1. ECHO maintenance procedure
  
  Exfoliating liquid shampoo
  
  CISPER Hair Revitalizing Shampoo (for oily scalp)
  
  CISPER Hair Revitalizing Scalp Restorer (for oily scalp)
  
  CIPSER Hair Revitalizing Serum
  
  Study period:
  
  The subject returned to the laboratory before use and 30, 60, 90, and 180 days after use, for a total of 5 times for measurement using the patented test method of MacroHI Co., Ltd and Scalp X scalp quantitation analysis system.
  
  Evaluation and statistical analysis:
  1. Evaluation method: Scalp X scalp quantitation analysis system was used for measurement and the units were absolute scores set in the device. Hair data was recorded.
  2. Statistical methods: Data obtained by averaging all test values were used for analysis using ANOVA and SPSS statistical software and this data was compared to the pre-test data.
  - SPSS statistical software: Abbreviation for Statistical Product and Service Solutions and is an umbrella term for software and related services for statistical analysis operation, data mining, prediction analysis, and decision support tasks that is produced by IBM company.
  1. The androgenetic alopecia grade before use and 30, 60, and 90 days after usage were assessed by the physician.
    ※Most commonly used method for androgenetic alopecia currently: For males, the Hamilton-Norwood scale was used, which is divided into 7 stages, of which stage 7 was the most severe (Kuo, Chang, Chen, Wang, 2021).

1. Results of efficacy study of juliArt ECHO scalp care

2. Scalp X scalp quantitative analysis system results

Absolute values of total hair density (right, left, top) of 18 subjects before and after use and improvement rate

Absolute values of hair shaft diameter (right, left, top) of 18 subjects before and after use, and improvement rate

Absolute values of thin hair density ratio (right, left, top) of 18 subjects before and after use, and improvement rate

3. Scalp X scalp quantitative analysis system results

Graphs on significant differences in Scalp X scalp quantitative analysis system result improvement rates

Figure 1. Graph of significant differences in total hair density improvement rate
The Scalp X scalp quantitative analysis system was used to measure total hair density and p<0.05 on 30 days after use and p<0.001 on 60, 90, and 180 days after use. The experimental results showed that there was significant positive improvement in total hair density in affected areas after 30, 60, 90, and 180 days of use.
The data showed that when (*p<0.05, **p<0.01, ***p<0.001), there were significant statistical differences between experimental groups.

Figure 2. Graph of significant differences in hair shaft diameter improvement rate

The Scalp X scalp quantitative analysis system was used to measure hair shaft diameter and there was no significant difference between 30, 60, 90, and 180 days after use and before use.

Figure 3. Graph of significant differences in thin hair density improvement rate

The Scalp X scalp quantitative analysis system was used to measure thin hair density and there was no significant difference between 30, 60, 90, and 180 days after use and before use.

Conclusion
Results of efficacy study of juliArt ECHO scalp care

In this study, the patented test method of MacroHI Co., Ltd and Scalp X scalp quantitation analysis system were used to measure the improvement in total hair density, hair shaft diameter, and thin hair density of affected areas in 18 subjects after using juliArt exfoliating liquid shampoo, juliArt CISPER hair revitalizing shampoo, juliArt CISPER hair revitalizing scalp restorer, and juliArt CISPER hair revitalizing serum.

The study results were as follows:

Total hair density
In this experiment, the Scalp X scalp quantitative analysis system was used to measure improvements. The mean improvement rates after 30, 60, 90, and 180 days were 13.48%, 20.50%, 21.94%, and 18.56%, respectively. The significant difference analysis results showed p<0.05 after 30 days and p<0.001 after 60, 90, and 180 days, proving that using juliArt exfoliating liquid shampoo, juliArt CISPER hair revitalizing shampoo, juliArt CISPER hair revitalizing scalp restorer, and juliArt CISPER hair revitalizing serum led to a significant positive improvement in total hair density.
Hair shaft diameter
In this experiment, the Scalp X scalp quantitative analysis system was used to measure improvements. The mean improvement rates after 30, 60, 90, and 180 days were 4.47%, -1.94%, 0.00%, and -1.80%, respectively. The significant difference analysis results showed that using juliArt CISPER hair revitalizing shampoo, juliArt CISPER hair revitalizing scalp restorer, and juliArt CISPER hair revitalizing serum did not lead to a statistically significant difference in hair shaft diameter.
Thin hair density
In this experiment, the Scalp X scalp quantitative analysis system was used to measure improvements. The mean improvement rates after 30, 60, 90, and 180 days were 2.78%, 12.26%, 16.64%, and 16.89%, respectively. The significant difference analysis results showed that using juliArt CISPER hair revitalizing shampoo, juliArt CISPER hair revitalizing scalp restorer, and juliArt CISPER hair revitalizing serum did not lead to a statistically significant difference in thin hair density.
Physician evaluation
Physician-assessed androgenetic alopecia grade:
A-01: alopecia grade changed from 4 to 3
A-02: alopecia grade changed from 4 to 2
A-03: alopecia grade changed from 4 to 3
A-04: alopecia grade changed from 4 to 3
A-05: alopecia grade changed from 4 to 3
A-06: alopecia grade changed from 4 to 3
A-07: alopecia grade changed from 4 to 4
A-08: alopecia grade changed from 4 to 3
A-09: alopecia grade changed from 3 to 2
A-10: alopecia grade changed from 3 to 2
A-11: alopecia grade changed from 4 to 4
A-12: alopecia grade changed from 2 to 1
A-13: alopecia grade changed from 4 to 2
A-14: alopecia grade changed from 2 to 1
A-15: alopecia grade changed from 2 to 1
A-16: alopecia grade changed from 2 to 1
A-17: alopecia grade changed from 4 to 2
A-18: alopecia grade changed from 2 to 2

Out of the 18 subjects, the physician assessed that there was improvement in androgenetic alopecia in 15 subjects. The evaluation results showed that using juliArt CISPER hair revitalizing shampoo, juliArt CISPER hair revitalizing scalp restorer, and juliArt CISPER hair revitalizing serum had led to positive improvements in 83% of subjects.

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V. References

1. Chao-Kuan Li (2014). Efficacy assessments of the facial mask materials in skin care. Master’s thesis in Department of Cosmetic Science
Chia-Nan, University of Pharmacy and Science 1-104. Bonaparte, J. P., Ellis, D., & Chung, J. (2013). The effect of probe to skin contact force on Cutometer MPA 580 measurements. J Med Eng Technol, 37(3), 208-212.
2. Kuo PF, Chang PF, Chen HZ, Wang TF (2021). Perioperative nursing experience of caring for a middle-aged adult having taken hair transplantation surgery for the second time, Tzu Chi Nursing Journal, 20(6), 130-140.