Impact of a Topical Cosmetic Product Intended to Promote the Health and Appearance of Women’s Hair

NCT06060834.

Hair loss can be a major source of psychological distress, impacting individual’s quality of life [1,2]. While there are many different types of hair loss, the most common in women is female pattern hair loss, also referred to as androgenetic alopecia, which affects 20% of adult women in the United States [2,3]. 

The global market for hair loss treatments is a multi-billion dollar industry [4]. In 2023, the alopecia market was $8.77 billion, with the interest in female alopecia treatments in particular projected to increase over the next few years (“Alopecia Market Size, Share & Growth Analysis Report, 2030,” n.d.). Women spend significant amounts of money annually on products and treatments specifically focused on hair growth including injections, transplants, and stem cells [3]. In a survey of 100 individuals experiencing chronic alopecia, two-thirds reported buying at least one over the counter product for hair growth [5]. Only two drugs have received FDA approval for treating androgenetic alopecia, Minoxidil and Finasteride, both of which have known side effects, motivating many individuals to seek out natural products [6]. Additionally, Finasteride does not work for all female pattern hair loss [7]. 

Aside from potential concern for adverse effects, individuals seek out complementary and alternative medicine options such as natural hair products for a variety of reasons, including availability, affordability, and their ability to be used in combination for a more robust biochemical action [8]. While some herbal/botanical components can help maintain the anagen (growth) phase in hair, others may be used to inhibit apoptosis in the catagen (regression) phase [9]. Various herbs and botanicals have been identified as having properties that are beneficial to hair health and combatting hair loss [10,11]. Although many herbal, botanical, and natural product lack the scientific evidence backed by human clinical trials [8], there have been numerous oral and topical natural products clinically studied that have been shown to be efficacious for alopecia [8,12,13].               

This present pilot study used an open-label design and enrolled 14 women with hair dissatisfaction to investigate the impact of a daily topical botanical product applied to women’s hair on perceived hair quality and overall well-being over a 30-day period. Hair density was measured via photo-analyses of scalp images with the mobile application, MyHairCounts, and hair loss was assessed with the 60-second hair comb test. We hypothesized that hair quality would be improved over time, based on subjective/perceived and objective measures.

• Subjects 

Fourteen women between 35 and 70 years of age who were not lactating, pregnant, or trying to become pregnant and who had regular/stable menstrual cycles or who were post-menopausal were recruited to participate. All subjects provided informed consent prior to completing the open label, pilot study. Subjects were non-smokers with self-reported limp or visibly thin hair and experiencing mild to moderate hair thinning. They did not have any known health conditions that would affect their hair health. Individuals with a clinically significant medical history (including alopecia), baldness, or significant loss of hair were not included. In addition, individuals must not have used medications or supplements for hair loss during the three months prior to the study and had no history of allergic/sensitive reactions to test product components. All procedures were approved by the University of Memphis Institutional Review Board for Human Subjects Research (protocol PRO-FY2024-1), and the study was registered through clinicaltrials.gov (NCT06060834). 

• Study material 

The patent-pending product formulated by Mirparm LLC (Woodland, CA) contains 11 ingredients (cayenne pepper, coconut water, kelp, lemon juice, Oxynex LM [Merck KGaA], potassium sorbate, red palm oil, rose water, saw palmetto, and vitamin C) that have a well-established history of use in various cosmetic and personal care products, with some having established benefits for supporting hair health. 

The product was applied daily using a supplied eye dropper. Subjects were instructed to apply 3 droppers once daily after shampooing. If the subject was not shampooing, subjects were instructed to apply to wet hair and then rinse. The product was to be applied directly to scalp (middle and each side) and the product was then massaged into the scalp for 30 seconds prior to rinsing out. The product was refrigerated prior to distribution to the subjects. Subjects were informed to store the product at room temperature. 

• Study procedures 

During the initial visit to the laboratory, subjects completed the informed consent form, health history and medication/dietary supplement history. The health history and medication/dietary supplement questionnaire were reviewed by the investigators for any contraindicators. Subjects were escorted to a private restroom within the lab where they self-collected a urine sample for a urine pregnancy test to be completed (assuming pre-menopausal). Subjects’ heart rate and blood pressure, height, weight, waist, and hip circumference were measured and are reported in table 1. 

Table 1: Baseline subject characteristics (N=14).

Note: Women had self-reported limp or visibly thin hair and experienced mild to moderate hair thinning, were not taking medications or supplements, and did not have health conditions that would affect hair health; individuals with clinically significant medical history (including alopecia), baldness or significant loss of hair were not included. 

Participants reported to the lab on three days (day 1, day 15, day 30) having shampooed for the last time between 24 and 36 hours prior to each test visit. Testing was conducted in the morning hours and at the same time of day for each subject. Upon arrival, subjects were escorted to a private restroom within the lab where they again self-collected a urine sample to perform a pregnancy test. Blood pressure and heart rate were measured after resting for 10 minutes, and then subjects completed a brief questionnaire pertaining to their hair quality and overall well-being. They also had photos taken of their hair (top of head) by trained investigators for analysis using the “MyHairCounts” app. The app provides data specific to the following scalp variables: hair density (hairs per cm²), grayness, and dandruff. Finally, they completed the 60-second hair comb test in the laboratory using a Cleopatra 400 comb (Krest, Leominster, MA) over a pillowcase. Hairs were counted by investigators following completion of the test [14-16]. At the first visit, subjects were provided with the test product and instructions for application. At the final visit, subjects were asked to complete a product assessment questionnaire. 

• Data analysis 

A total of 14 participants were included in the analysis. Variables were measured at baseline, second visit (day 15) and third visit (day 30). A repeated measures ANOVA was conducted to assess the changes of hair counts and hair density over time, and Bonferroni correction was used for multiple comparisons adjustments. Significance was set at p < 0.05).

• Study population 

A total of 14 women completed all aspects of the study. An additional participant provided informed consent and met inclusion criteria but was unable to participate due to scheduling conflicts. The participants had a mean age of 48.9 ± 8.9 years. Descriptive data on subject population is presented in table 1. No changes to blood pressure or heart rate were observed throughout the entire study period (results not shown). 

• Outcomes 

Subject perceptions of hair characteristics and well-being: Responses specific to the perceived hair quality and well-being questionnaires at each visit are summarized in table 2. Subjects were more satisfied with their hair following 30 days of treatment. There was a significant difference between the three visits with F_(2,26) = 8.356 and p = 0.002. Pairwise comparisons found the only difference was found between the third visit and baseline visit (p = 0.01). 

Table 2: Self-reported hair quality and overall well-being.

Note: Hair responses for how the subject was currently feeling at each visit for the time, with 0 (extremely poor) to 10 (excellent) for Hair thickness, fullness, shininess, texture, strength, overall appearance, and satisfaction; 0 (never) to 10 (very often) for compliments, and split ends; 0 (very difficult) to 10 (very easy) for styling; and 0 (very slow) to 10 (very fast) on a continuous scale. Similarly, well-being responses for how the subject was currently feeling about each prompt from 0 (extremely poor) to 10 (excellent) using a continuous scale. 

In addition to overall hair quality, there was a significant difference in subject’s perceived hair thickness between the three visits with F_(2,26) = 16.898 and overall p < 0.001. By checking the pairwise comparisons, there was a significant difference between the first visit and second visit with p = 0.007 and between the first and third visit with p < 0.001, indicating subjects perceived their hair was thicker following treatment. Similarly, subjects perceived their hair was shinier after using the product for 15 and 30 days. There was a significant difference between the three visits with F_(2,26) = 8.034 and overall p = 0.002. Pairwise comparisons found there was a significant difference between the first and third visit with p = 0.02. Hair strength was also found to be significantly different between the three visits with F_(2,26) = 11.563 and p = 0.002. Significant differences were observed for pairwise comparisons between the first and third visit with p = 0.004 and the second and third visit with p = 0.01. Hair growth was also significantly different between the three visits with F_(2,26) = 13.223 and p < 0.001. There was a significant difference between the first and second visit with p = 0.005 and significant difference between the first and third visits with p = 0.003. No significant difference between the second and third visit was observed for hair thickness, shininess, strength, or speed of growth. No significant differences were detected for hair texture, fullness, appearance, split ends, ease of styling nor were there any differences reported in receiving more compliments or any of the well-being questions including confidence, self-consciousness, motivation, and perceived attractiveness (p>0.05). 

Hair density and count: Hair density and counts as determined by the mobile application MyHairCounts (Houston, TX) are summarized in table 3. There was no significant difference in hair density or counts for any of the three individual measured sites (front, back, center), nor on average (p > 0.05). 

Table 3: Hair density and counts as determined via MyHairCounts [mean (SD)]. 

Comb test: The average number of hairs lost by subjects at each visit while completing the 60-second comb test are summarized in table 4 and figure 1. A significant difference was found between the three visits with F_(2,26) = 4.547 with p = 0.02. More specifically, by checking the pairwise comparison, there was a significant difference between the first and third visit with p = 0.016, which means their hair loss in the first (baseline) visit was significantly higher than the third visit. No significant difference between the first and second, or between the second and third visits. 

Table 4: Hairs counted following comb test [mean (SD)].

 Figure 1: Scatter and box plots of hairs collected from 60 second comb test.

Subject perceptions of product: Overall, subjects found the product easy to use (7.0 +/- 1.7 out of 10) and enjoyed the smell (7.2 +/- 2.3 out of 10). The perception of product effectiveness varied among subjects (5.8 +/- 2.4) There were no adverse events/side effects reported with treatment. Results are detailed in table 5.

 Table 5: Product assessment performed by 14 women after using the product for 30 days.

Note: Product assessment answers were assessed at the final visit by each subject with 0 (not at all) to 10 (very much) for each variable on a continuous scale. 

The purpose of this study was to determine the effect of a topical botanical cosmetic product on hair quality and health. Similar to other hair loss supplements, this test product uses multiple ingredients indicated to be favorable for thinning hair to facilitate a more robust response [7,17-19], including cayenne pepper, saw palmetto, and kelp. Cayenne pepper contains capsaicin which has previously been shown to induce the anagen phase of hair growth [10,19-21]. Similar to the drug Finasteride, saw palmetto works through the inhibition of 5α-reductase [12,18,22,]. In addition, seaweeds including kelp have many beneficial properties suitable for cosmetic uses [23,24]. Research has shown that kelp treatment can improve the tensile strength of hair and may help prevent hair damage [25] and, when taken orally in combination with other herbal compounds, improves hair growth in women [26]. 

Hair density determined through photo-analyses via the MyHairCounts mobile application and a 60-second comb test were used as concrete, objective measures of the product’s effect on hair health/loss. No changes in hair count or hair density were observed with use of the test product. Considering the phase lengths of the hair cycle, the length of this pilot study was likely not sufficient enough to capture these changes of hair loss [10]. 

Although we are unable to detect changes in hair density within the short study period, hair loss during the comb test was decreased following treatment, which could have been due to less hair breakage and/or hair loss. Additionally, subjective measures—specifically, subject’s feelings towards their hair quality—were improved. Previous research has demonstrated that an individual’s feelings about their hair impacts their self-esteem and overall well-being [2]. Application of the product for 30 days resulted in subjective improvements in hair thickness, hair shininess, hair strength, overall hair satisfaction, and speed of growth—all of which may have implications to overall self-esteem. A longer-term, placebo-controlled trial is needed to extend these findings. 

In accordance with our hypothesis, using the topical product resulted in significant subjective improvements, in addition to a significant decrease in the number of hairs lost during comb tests after 30 days of treatment. These findings suggest a positive effect of treatment and provide rationale for further and longer-term investigation. As a pilot study, the number of subjects was low and the length of treatment short, which greatly limited our ability to detect more robust changes in hair quality measures. Previous hair loss research studies are typically 6 months or longer, although some benefits were observed at 2 and 3 month timepoints for multiple different herbal products [8,12]. Future studies should extend to longer timepoints (3-12 months) to determine whether this combination of botanicals can stimulate meaningful changes in hair density and decrease hair loss. Further, future studies should assess different hair types (vellum/terminal) and hair phases. 

While results appear promising, there are limitations that need to be considered. First, the study included no placebo condition. Therefore, subjects may have reported improvements in the subjective assessments based on their expectations of an effect. For the comb test, values were indeed lower for this objective assessment. However, it is possible that other factors (e.g., hormonal changes across the menstrual cycle) may have contributed to the findings. Also, subjects were considered to be middle-aged on average. We do not know if these findings can be extrapolated to younger or older women and this needs to be evaluated in future research.

Subjects perceived a significant change in hair thickness, shininess, strength, and speed of growth after 15 and 30 days of applying the botanical cosmetic test product to their scalp in this pilot study. They also reported having more satisfaction with their hair after 30 days of use. No changes to well-being measures or hair density and count were noted. However, less hair loss was measured following a comb test performed in the laboratory after 30 days of use compared to baseline. A more in-depth investigation into potential benefits is warranted based on these preliminary findings.

1. Ramos PM, Miot HA (2015) Female Pattern Hair Loss: A Clinical and Pathophysiological Review. Anais Brasileiros de Dermatologia 90: 529-543.
2. Davis DS, Callender VD (2018) Review of Quality of Life Studies in Women with Alopecia. International Journal of Women’s Dermatology 4: 18-22.
3. Sadick N, Arruda S (2021) Understanding Causes of Hair Loss in Women. Dermatologic Clinics 39: 371-374.
4. Marks DH, Penzi LR, Ibler E, Manatis-Lornell A, Hagigeorges D, et al. (2019) The Medical and Psychosocial Associations of Alopecia: Recognizing Hair Loss as More Than a Cosmetic Concern. American Journal of Clinical Dermatology 20: 195-200.
5. Ingrassia JP, Buontempo MG, Alhanshali L, Akoh CC, Glick S, et al. (2023) The Financial Burden of Alopecia: A Survey Study. International Journal of Women’s Dermatology 9: 118.
6. Ashique S, Sandhu NK, Haque SN, Koley K (2020) A Systemic Review on Topical Marketed Formulations, Natural Products, and Oral Supplements to Prevent Androgenic Alopecia: A Review. Natural Products and Bioprospecting 10: 345-365.
7. Le Floc'h C, Cheniti A, Connétable S, Piccardi N, Vincenzi C, et al. (2015) Effect of a Nutritional Supplement on Hair Loss in Women. Journal of Cosmetic Dermatology 14: 76-82.
8. Herman A, Herman AP (2017) Topically Used Herbal Products for the Treatment of Hair Loss: Preclinical and Clinical Studies. Archives of Dermatological Research 309: 595-610.
9. Škulj AZ, Poljšak N, Kocevar Glavac N, Kreft S (2020) Herbal Preparations for the Treatment of Hair Loss. Archives of Dermatological Research 312: 395-406.
10. Barve K, Dighe A (2016) The Chemistry and Applications of Sustainable Natural Hair Products. SpringerBriefs in Molecular Science. Cham: Springer International Publishing, USA.
11. Rathi V, Rathi JC, Tamizharasi S, Pathak AK (2008) Phcog Rev.:Short Review Plants Used for Hair Growth Promotion: A Review. Pharmacognosy Reviews 2.
12. Hosking AM, Juhasz M, Mesinkovska NA (2018) Complementary and Alternative Treatments for Alopecia: A Comprehensive Review. Skin Appendage Disorders 5: 72-89.
13. Ezekwe N, King M, Hollinger JC (2020) The Use of Natural Ingredients in the Treatment of Alopecias with an Emphasis on Central Centrifugal Cicatricial Alopecia: A Systematic Review. The Journal of Clinical and Aesthetic Dermatology 13: 23-27.
14. Wasko CA, Mackley CL, Sperling LC, Mauger D, Miller JJ (2008) Standardizing the 60-Second Hair Count. Archives of Dermatology 144: 759-762.
15. Lewallen R, Francis S, Fisher B, Richards J, Li J, et al. (2015) Hair Care Practices and Structural Evaluation of Scalp and Hair Shaft Parameters in African American and Caucasian Women. Journal of Cosmetic Dermatology 14: 216-223.
16. Miller JJ, Fang S (2004) Results of 60-Second Timed Hair Counts in Women between the Ages of 20–60 Years. Journal of the American Academy of Dermatology 50: 93.
17. Ablon G, Kogan S (2018) A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair. J Drugs Dermatol 17: 558-565.
18. Farris PK, Rogers N, McMichael A, Kogan S (2017) A Novel Multi-Targeting Approach to Treating Hair Loss, Using Standardized Nutraceuticals. J Drugs Dermatol 16: 141-148.
19. Mao Y, Xu Z, Song J, Xie Y, Mei X, et al. (2022) Efficacy of a Mixed Preparation Containing Piperine, Capsaicin and Curcumin in the Treatment of Alopecia Areata. Journal of Cosmetic Dermatology 21: 4510-4514.
20. Lourith N, Kanlayavattanakul M (2013) Hair Loss and Herbs for Treatment. Journal of Cosmetic Dermatology 12: 210-222.
21. Harada N, Okajima K, Arai M, Kurihara H, Nakagata N (2007) Administration of Capsaicin and Isoflavone Promotes Hair Growth by Increasing Insulin-like Growth Factor-I Production in Mice and in Humans with Alopecia. Growth Hormone & IGF Research: Official Journal of the Growth Hormone Research Society and the International IGF Research Society 17: 408-415.
22. Evron E, Juhasz M, Babadjouni A, Mesinkovska NA (2020) Natural Hair Supplement: Friend or Foe? Saw Palmetto, a Systematic Review in Alopecia. Skin Appendage Disorders 6: 329-337.
23. Pereira L (2018) Seaweeds as Source of Bioactive Substances and Skin Care Therapy—Cosmeceuticals, Algotheraphy, and Thalassotherapy. Cosmetics 5: 68.
24. López-Hortas L, Flórez-Fernández N, Torres MD, Ferreira-Anta T, Casas MP, et al. (2021) Applying Seaweed Compounds in Cosmetics, Cosmeceuticals and Nutricosmetics. Marine Drugs 19: 552.
25. Kim, J-S, Jeon Y-H (2021) A Study of Effects of Laminaria japonica Extract on Improvement of Hair Damage. Journal of the Korean Applied Science and Technology 38: 986-993.
26. Ablon G, Kogan S (2021) A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair. Journal of Drugs in Dermatology 20: 55-61.