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1 Original STUDY Polyherbal Formulation (Hairzone Solution) in the Management of Diffuse Hair Loss: Post Marketing Safety and Efficacy Study J Prasad*, Suprabha Hegde** Abstract Hair loss is a common and distressing problem, affecting men and women of all the ages and ranging from a small bare patch to a more diffuse and obvious pattern. The purpose of this study is to evaluate the safety and efficacy of Hairzone solution in diffuse hair loss. Twenty-eight cases were included in the study according to the subject selection criteria. All the patients were advised to gently massage the solution into the scalp part by part, covering the whole area of the scalp and to rinse it in the morning. The response to therapy was evaluated at monthly intervals for a period of six months. The changes in various parameters from baseline values and the values at each visit for six months were evaluated statistically using Graph Pad Prism Version 4.03 for windows, Graph Pad Software, San Diego, California, United States. The criteria for evaluation were signs and symptoms such as reduction in hairfall by 1-minute combing test, reduction in associated symptoms like itching and overall impression. The study clearly demonstrated the beneficial effects of Hairzone solution in diffuse hair loss as evident by reduced hair fall by 1-minute combing test, in addition to decrease in itching. Hair loss was reduced in 21 of 28 patients. Further safety of the product was also substantiated by clinical parameters. Therefore, it can be concluded that Hairzone solution is safe and effective in the management of diffuse hair loss. Keywords: Hairzone solution, diffuse hair loss Scalp hair grows in cycles, with each hair follicle undergoing cycles in its lifetime. 1 Diffuse hair shedding is the result of a disruption of one phase of the hair cycle, 2,3 i.e., anagen (active hair growth), catagen (involution) or telogen (resting). The anagen phase can last 2-8 years. 4 The catagen phase lasts 4-6 weeks, and the telogen phase lasts 2-3 months. The exogen phase (the release of dead hair) coincides with the end of the telogen phase. Most people have about 100,000 scalp hairs; normally 10-15% of these are in the telogen phase. 5 Shedding of telogen hairs per day is normal. 4 Anagen hair loss is never normal. The most common cause of diffuse hair loss is androgenetic alopecia (male-pattern alopecia). In men, androgenetic alopecia causes typical temporal recession (thinning of the hair around the temples) and thinning at the vertex (Hamilton patterns). In women, *Consultant Dermatologist BNR Skin Clinic, Near Garuda Mall, Bangalore **Research Associate, R&D Center The Himalaya Drug Company, Makali, Bangalore Address for correspondence Dr Suprabha Hegde Research Associate, R&D Center The Himalaya Drug Company, Makali, Bangalore a more diffuse alopecia is generally seen (Ludwig pattern). Other causes of diffuse hair loss include telogen effluvium, severe iron deficiency and protein deficiencies. These conditions cause thinning of hair over the whole scalp, in contrast to the frontovertical loss seen in androgenetic alopecia. They can also exacerbate the hair thinning of androgenetic alopecia. Both hypothyroidism and hyperthyroidism can cause diffuse telogen hair loss that is usually reversible once the euthyroid state is restored. 5,6 Chronic systemic disorders can cause telogen hair shedding. Telogen hair loss has also been reported in autoimmune diseases and in chronic infections. 7,8 Poor protein intake, essential fatty acid deficiency and malabsorption are few other factors that cause diffuse hair loss. When assessing diffuse hair loss, it is important to examine the scalp closely to exclude an inflammatory scalp disease or scarring alopecia. Assessment should also include: Detailed medical history, complete blood count, comprehensive metabolic panel, thyroid function tests, iron and ferritin levels, and zinc level to identify any underlying systemic disease, thyroid disease and nutritional deficiency. The hair shafts should be examined for length, diameter and breakage. Broken 387

2 hairs can suggest trichotillomania, traction alopecia, tinea capitis or a trichodystrophy. Signs of hyperandrogenism such as acne, seborrhea and hirsutism should also be identified. Skin and nail examinations are important parts of the clinical examination. Hair pull tests can be also useful. 9 The hair pull test will be positive where the hair is thinning, but negative away from the thinning areas. Certain species of fungi fluoresce green under a Wood s lamp, and Malassezia (Pityrosporum) species, which cause seborrheic dermatitis, fluoresce orange. 10 Bacterial and fungal cultures should be obtained if pustules or scales, respectively, are present on the scalp. Light microscopy of clipped hair can reveal hair-shaft abnormalities. A 4 mm scalp biopsy is helpful in most hair-loss conditions. 9 If signs of androgen excess are present, an androgen screen is needed to exclude an androgen-secreting tumor or other endocrinopathy. 11 Anagen hair loss is usually managed with observation and support. In men, medical treatment of androgenetic alopecia includes topical minoxidil (2% or 5%) and oral finasteride. Treatment with finasteride can cause decreased libido, impotence and ejaculation disorders. 12 Finasteride may also induce depression. 13 Women can also use topical minoxidil; A hyperandrogenic state may limit the success of treatment with minoxidil. 14 In these women, spironolactone mg daily may slow the rate of hair loss. 15,16 Antiandrogens cause feminization of the male fetus; hence, all women of childbearing age should be on a reliable form of contraception. 11 Women with evidence of a hyperandrogenic state requesting combined oral contraceptives would benefit from using antiandrogenic progesterones, such as drospirenone. 17 Finasteride is ineffective in postmenopausal women with female pattern hair loss. 18 Over-the-counter topical preparations, hair extensions, and hairpieces are available for women with poor response to treatment. Hairzone solution, a polyherbal formulation is available in the market and is known to be beneficial in patients suffering from hair loss. Aim of the study To evaluate the safety and efficacy of Hairzone solution in diffuse hair loss. Material and Methods This study was an open post marketing clinical trial conducted at BNR Skin Clinic, Bangalore, between June 2010 and March The study protocol, case report forms, regulatory documents, product information and informed consent forms were approved by Independent Ethics Committee. A total of 28 patients of both sexes, in the age group of years, who were suffering from diffuse hair loss, and who were willing to give informed written consent were enrolled in the study. Patients on immunosuppressive drugs, patients applying other topical therapy for diffuse hair loss, in the last two weeks prior to the initiation of the study, patients with evidence of skin infection and pregnant and lactating women were excluded from the study. Patients who were not willing to give informed written consent were excluded from the study. Study Procedure Each patient s demographic medical history (especially local fungal infection, dandruff, pediculosis, trichotillomania, stress, diet, past illness and drugs), and treatment details were recorded. All the enrolled patients underwent a thorough clinical examination including scalp skin examination, which included the assessment of number of hairs lost in 1-minute combing test and the presence of alopecic patches. All the patients were advised to gently massage the solution into the scalp part by part, covering the whole area of the scalp and to rinse it in the morning. The response to therapy was evaluated at once a month for the period of six months. The criteria for evaluation were signs and symptoms like reduction in associated symptoms like itching, 1-minute comb test and overall impression. Response for 1-minute comb test was evaluated as number of hair fall. Itching was evaluated on an Analog scale of 0-3 (0-Nil, 1-Moderate, 2-Good, 3-Excellent). The overall response was in turn correlated with response to the treatment as follows: Grade 0: No improvement Grade 1: Poor response <25% reduction Grade 2: Moderate response 25-49% reduction Grade 3: Good response 50-74% reduction Grade 4: Excellent response >75% reduction All the adverse events, either reported or observed by the patients, were recorded with information about severity, date of onset, duration and action taken regarding the study drug. Relation of adverse events to study medication was predefined as Unrelated (a reaction that does not follow a reasonable temporal sequence from the administration of the drug), Possible (follows a known response pattern to the suspected 388

3 drug, but could have been produced by the patient s clinical state or other modes of therapy administered to the patient), and Probable (follows a known response pattern to the suspected drug that could not be reasonably explained by the known characteristics of the patient s clinical state). Patients were allowed to voluntarily withdraw from the study, if they had experienced serious discomfort during the study or sustained serious clinical events requiring specific treatment. For patients withdrawing from the study, efforts were made to ascertain the reason for dropout. Noncompliance (defined as failure to take <80% of the medication) was not regarded as treatment failure, and reasons for noncompliance were noted. Primary and Secondary Endpoints The predefined primary efficacy endpoint was a decrease in the symptom score for diffuse hair loss. The predefined secondary safety endpoints were acute and chronic safety, as assessed by the incidence of adverse events and patient compliance to therapy. Statistical Analysis Statistical analysis was done according to intention-totreat principles. The changes in various parameters from baseline values and follow-up visits at once a month for six months were evaluated for hair loss in 1-minute comb test by repeated measures of ANOVA followed by Tukey s multiple comparison test. Itching was analyzed by repeated measures of ANOVA using Friedman test followed by Dunnett s multiple comparison test. Statistical analysis was performed using GraphPad Prism Version 4.03 for windows, GraphPad Software, San Diego, California, United States. Results The demographic details of subjects included in the study are listed in Table 1. There were eight males and 20 females in the study. Duration of illness was 2.60 ± 1.99 years. The number of hair loss in 1-minute comb test at the end of first month was ± (Table 2). It reduced with treatment to ± (p < 0.05) at the end of two months, to ± 8.38 (p < 0.05) at the end of three months, which further reduced to ± 9.34 (p < 0.001) at the end of four months, to ± Table 1. Demographic Data of Patients on Entry Number of patients 28 Male: Female Male: 8; Female: 20 Diet Vegetarian: 60 Mixed: 40 Mean age (years) ± 9.60 Weight in kg (mean ± SD) ± H/o smoking (n) 8 H/o alcohol consumption (n) 2 Duration of hair loss (years) 2.60 ± 1.99 H/o: History of. Table 2. Number of Hair Loss in 1-minute Treatment period Hair loss Significance 1st month ± nd month ± a p< rd month ± 8.38 a p < 0.001, b p < th month ± 9.34 a,b p < th month ± a,b,c p < th month 9.82 ± 9.08 a,b,c,d p < a As compared to first month, b as compared to second month, c as compared to third month, d as compared to fourth month. Statistical analysis: Repeated measures of ANOVA following Tukey s multiple comparison test. (p < 0.001) at the end of five months and which further reduced to 9.82 ± 9.08 (p < 0.001) at six months; the significance values are as compared to the values in the first month. Itching at the end of first month was 1.53 ± It reduced with treatment to 1.21 ± 0.54 at the end of two months, which again reduced to 0.95 ± 0.62 at the end of three months, to 0.58 ± 0.61 (p < 0.01) at the end of four months, to 0.47 ± 0.51 (p < 0.01) at the end of five months and further reduced to 0.47 ± 0.51 (p < 0.01) at six months; all the significance values are as compared to the first month values (Table 3). Assessment of overall response is listed in Table 4. At the end of the study, 4 (10.71%) cases reported marked improvement, 9 (35.71%) cases reported moderate improvement, 10 (35.71%) cases reported slight improvement and 5 cases reported no change (Table 4). Hair loss reduced in 21/28 patients (75%); 25% patients reported no change. The safety evaluation of the investigational product was also evaluated. It was found that there were no adverse effects on application of the product for the period of the study. 389

4 Table 3. Effect of Hairzone Solution on Itching Treatment period Itching score Significance 1st month 1.53 ± nd month 1.21 ± 0.54 NS 3rd month 0.95 ± 0.62 NS 4th month 0.58 ± 0.61 a p < th month 0.47 ± 0.51 a p < 0.01, b p < th month 0.47 ± 0.51 a p < 0.01, b p < 0.05 a As compared to first month, b as compared to second month. Statistical analysis: repeated Measures of ANOVA using Freidman fest followed by Dunnett s multiple comparison test. Table 4. Overall Impression Overall impression Symptoms become worse 0 Discussion Response No change 5 (17.87%) Slight improvement 10 (35.71%) Moderate improvement 9 (35.71%) Marked improvement 4 (10.71%) Cured 0 Various factors contribute to hair fall/loss. Genetic predisposition and hormonal factors predominantly contribute to the above. Disease states such as typhoid, malaria, jaundice, etc. and use of chemotherapeutic agents also cause hair fall. Hormone therapy, use of α- reductase inhibitors and vasodilators like minoxidil are widely used to reduce the hair fall/loss. The synthetic drug, minoxidil is a potent vasodilator appears safe for long-term treatment. Treatments available for the various forms of alopecia have limited success with unwanted adverse effects. New technologies in cosmetic transplant surgery and hair replacement systems are available that can be completely undetectable. The present study shows that Hairzone solution is beneficial in the management of diffuse hair loss. Hairzone solution consists of potent herbs, namely Butea monosperma and Butea parviflora. B. monosperma inhibits degeneration of hair follicles, extends the anagen phase of hair growth cycle and enhances proliferation and maturation of precursor epithelial cells of the final hair strand. It prevents the massive apoptosis in the proximal hair bulb and stimulates the multiplication of hair fiber cells with the stimulation of anagenic phase, and reduce the catagenic and telogenic phase. 19 B. monosperma displays antifungal activity against Cladosporium cladosporioides; 20 it also has a significant bactericidal effect 21 and potential antiviral activities. 22 B. monosperma has astringent action, 23,24 which shrinks or constricts body tissues, usually locally after topical medicinal application. Externally, applied astringents cause mild coagulation of skin proteins, dry, harden and protect the skin. Mildly astringent solutions are used to alleviate minor skin irritations resulting from superficial cuts, allergies, insect bites or fungal infections. B. monosperma has potent free radical scavenging activity, and has proven effective in promoting the therapeutic activity of Hairzone solution. 25 B. parviflora inhibits hair follicle degeneration and extends the anagen phase of hair growth cycle. It enhances proliferation and maturation of precursor epithelial cells of the final hair strand; it also prevents the massive apoptosis in the proximal hair bulb. B. parviflora stimulates the multiplication of hair fiber cells with the stimulation of anagenic phase, and reduces the catagenic and telogenic phase. It has antimicrobial action. 26 The efficacy of Hairzone solution can be attributed to the synergistic effects of both these herbs, B. monosperma and B. parviflora. Conclusion This post marketing study clearly demonstrates the beneficial effects of Hairzone solution in diffuse hair loss. There was significant reduction in hair fall after two months of treatment, which further continued to show reduction until the end of the study. Similarly, itching also reduced with treatment and there was significant relief from four months until the end of the study. Hair loss reduced in 21 out of 28 cases treated with Hairzone solution. Further safety of the product was also substantiated by clinical parameters. Therefore, it can be concluded that Hairzone solution is safe and effective in diffuse hair loss. References 1. Harrison S, Sinclair R. Telogen effluvium. Clin Exp Dermatol 2002;27(5): Headington JT. Telogen effluvium. New concepts and review. Arch Dermatol 1993;129(3): Kligman AM. Pathologic dynamics of human hair loss. I. Telogen effluvium. Arch Dermatol 1961;83: Paus R, Cotsarelis G. The biology of hair follicles. N Engl J Med 1999;341(7):

5 5. Rook A, Dawber R. Chapter 1. The comparative physiology, embryology and physiology of human hair. In: Diseases of the Hair and Scalp. Rook A, Dawber R (Eds.), Blackwell Science Publications: Oxford, UK 1982:p Sperling LC. Hair and systemic disease. Dermatol Clin 2001;19(4):711-26, ix. 7. Bergfeld WF. Chapter 9. Telogen effluvium. In: Hair and Scalp Diseases: Medical, Surgical, and Cosmetic Treatments. McMichael J, Hordin MK (Eds.), Informa Health Care: London, UK 2008:p Apache PG. Eczematous dermatitis of the scalp. In: The Science of Hair Care. Zviak C (Ed.), Marcel Dekker: New York, NY 1986:p Shapiro J. Clinical practice. Hair loss in women. N Engl J Med 2007;357(16): Elewski BE. Clinical diagnosis of common scalp disorders. J Investig Dermatol Symp Proc 2005;10(3): Olsen EA, Messenger AG, Shapiro J, Bergfeld WF, Hordinsky MK, Roberts JL, et al. Evaluation and treatment of male and female pattern hair loss. J Am Acad Dermatol 2005;52(2): Leyden J, Dunlap F, Miller B, Winters P, Lebwohl M, Hecker D, et al. Finasteride in the treatment of men with frontal male pattern hair loss. J Am Acad Dermatol 1999;40(6 Pt 1): Rahimi-Ardabili B, Pourandarjani R, Habibollahi P, Mualeki A. Finasteride induced depression: a prospective study. BMC Clin Pharmacol 2006;6: Vexiau P, Chaspoux C, Boudou P, Fiet J, Jouanique C, Hardy N, et al. Effects of minoxidil 2% vs. cyproterone acetate treatment on female androgenetic alopecia: a controlled, 12-month randomized trial. Br J Dermatol 2002;146(6): Sinclair R, Wewerinke M, Jolley D. Treatment of female pattern hair loss with oral antiandrogens. Br J Dermatol 2005;152(3): Burke BM, Cunliffe WJ. Oral spironolactone therapy for female patients with acne, hirsutism or androgenic alopecia. Br J Dermatol 1985;112(1): Raudrant D, Rabe T. Progestogens with antiandrogenic properties. Drugs 2003;63(5): Price VH, Roberts JL, Hordinsky M, Olsen EA, Savin R, Bergfeld W, et al. Lack of efficacy of finasteride in postmenopausal women with androgenetic alopecia. J Am Acad Dermatol 2000;43(5 Pt 1): Rawal R, Kolhapure SA. Evaluation of the efficacy and safety of Hair Loss Cream (PCPB Hair Cream) in the management of telogen effluvium. Indian J Clin Pract 2005;16(5): Bandara BM, Kumar NS, Samaranayake KM. An antifungal constituent from the stem bark of Butea monosperma. J Ethnopharmacol 1989;25(1): Mehta BK, Dubey A, Bokadia MM, Mehta SC. Isolation and in vitro antimicrobial efficiency of Butea monosperma seed oil on human pathogenic bacteria and phytopathogenic fungi. Acta Microbiol Hung 1983;30(1): Yadava RN, Tiwari L. A potential antiviral flavone glycoside from the seeds of Butea monosperma O. Kuntze. J Asian Nat Prod Res 2005;7(2): Chopra RN, Nayar SL, Chopra LC. B. monosperma. Glossary of Indian Medicinal Plants. National Institute of Science Communication, 4th edition, New Delhi 1996: p Asolkar LV, Kakkar KK, Chakre OJ. B. monosperma. Glossary of Indian Medicinal Plants with Active Principles (second supplement). Part I (A-K), CSIR Publication, New Delhi 1992:p Lavhale MS, Mishra SH. Evaluation of free radical scavenging activity of Butea monosperma Lam. Indian J Exp Biol 2007;45(4): Asolkar LV, Kakkar KK, Chakre OJ. B. parviflora. Glossary of Indian Medicinal Plants with Active Principles (second supplement). Part I (A-K), CSIR Publication, New Delhi 1992:p

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