ORIGINAL ARTICLE

An Open Clinical Study to Evaluate Safety and Efficacy of Hairzone Solution in the Management of Diffuse Hair Loss
Uma Agarwal*, Deepa HS**, Suprabha Hegde**

ABSTRACT
Diuse hair loss can aect both sexes at any age. The present clinical study was conducted to evaluate the safety and ecacy of Hairzone solution in 28 patients with diuse hair loss. All the patients were instructed to gently massage the solution on to the entire area of the scalp, leave it overnight and rinse it in the morning. Response to the therapy was evaluated at the end of six weeks. Changes in various parameters from baseline values to the values at the end of six weeks were evaluated by Fisher exact test. Criteria for evaluation included parameters such as moisturizing eect and reduction in hair fall and associated symptoms such as itching and dryness of scalp. Results of the present study clearly demonstrated the benecial eects of Hairzone solution in diuse hair loss, as evidenced by decrease in hair fall, improvement in scalp condition and relief from itching. There were no signicant adverse reactions, either reported or observed, during the entire study period and the overall compliance to the treatment was good. Therefore, it may be concluded that Hairzone solution is clinically eective and safe in the management of diuse hair loss. Key words: Hairzone solution, diuse hair loss, alopecia

air loss is a common and distressing problem, aecting men and women of all ages. It can range from a small bare patch to a more diuse and obvious pattern. Diuse hair loss, a type of hair loss that can occur at any age, tends to aect the whole scalp rather than specic areas of it. Although medically benign, hair loss has been shown to have notably deleterious eects on body image, selfesteem and psychologic well-being of an individual.1 Androgenetic alopecia or pattern baldness, the most widespread form of hair loss, is a common disorder aecting both men and women. It aects upto 50% of men by the age of 50 years and upto 80% of men by the age of 80 years. Androgenetic alopecia is also present in a signicant number of women. It is estimated that 20-40% of women suer from this condition, although not with the same severity as men.2 In women, hair loss typically begins in their twenties to forties and continues to progress with increasing age. A number of factors are involved in hair disorders. Genetic factors, diet, endocrine abnormalities, drug
*Skin, Hair, Allergy Cosmetology Specialist Skin-a-Health Centre, Hooghly, West Bengal **Research Associate, R&D Center The Himalaya Drug Company, Makali, Bangalore Address for correspondence Dr Suprabha Hegde R&D Center The Himalaya Drug Company Makali, Bangalore - 562 123, Karnataka E-mail: dr.suprabha@himalayahealthcare.com

intake, hair shaft abnormalities and disease conditions such as typhoid, malaria and jaundice may cause hair fall.3 Most cases of hair loss are due to changes in hair cycle. The average rate of hair growth in a normal scalp is 0.35 mm a day; however, slower growth occurs in elderly people and in patients with chronic illness.4 Scalp hair grows in an asynchronous pattern, in three cyclic phases: Anagen (growth), catagen (involution) and telogen (rest). Approximately 80% of the hair follicles are present in the anagen phase, which may be as short as 2-6 years. The remaining 10-20% of the hair follicles are present in the catagen and telogen phases. The catagen phase, which is between two and three weeks, sees an increase in the growth activity of hair follicles. The hair follicles then move on to the nal phasetelogen-which lasts for 2-3 months. In this phase, the hair follicles move into resting state. In general, 100-150 telogen hairs are shed at random everyday.5 Most people have about 1,00,000 scalp hairs and normally 10-15% of these are in the telogen phase.6 A type of hair loss, traction alopecia is commonly found in individuals with ponytails or cornrows who pull on their hair with excessive force. Trichotillomania, another type of hair loss, is caused by compulsive pulling and bending of the hairs. It tends to occur more commonly in children than in adults. In this condition, although not completely absent from
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the scalp, the hair breaks easily. Trauma conditions such as chemotherapy, childbirth, major surgery, poisoning and severe stress may cause a type of hair loss known as telogen euvium. Worrisome hair loss is often seen in women after childbirth. Alopecia areata, also known as spot baldness, is an autoimmune disorder, which can result in hair loss at one location (Alopecia areata monolocularis) to the entire body (Alopecia areata universalis). Iron deciency is a common cause of hair thinning, though frank baldness is not usually seen. Radiation to the scalp, in radiotherapy for the treatment of certain cancers, may cause baldness of the irradiated areas. Hypothyroidism can cause hair loss, typically frontal and is particularly associated with thinning of the outer third of the eyebrows. Hyperthyroidism can also cause hair loss, which is parietal rather than frontal. Temporary loss of hair can occur in areas where sebaceous cysts are present for considerable duration; normally one to several weeks in length. The diagnosis of hair disorders is complex, and diagnostic techniques include clinical examination such as scalp condition; hair loss pattern; length and diameter of hair bers; hair pulls; one-minute combing test; clipping, plucking and microscopic examination of hair bers; scrapings of scalp scales for microbial culture and scalp-punch biopsy. Other laboratory tests such as complete blood count, ferritin measurement, and thyroid screening may be helpful. Several therapies are available for hair loss, and biological response modiers (e.g., topical minoxidil) and selective antiandrogens are the most commonly used treatment options. In women, in addition to the antiandrogens, hormone replacement therapy can be used. Use of systemic corticosteroids is controversial because of prolonged treatment duration and potential side eects, which include cataract, osteopenia, osteoporosis and growth retardation.7 In the present study, Hairzone solution, containing the extracts of Butea monosperma and Butea parviora, is evaluated for its ecacy and safety in the management of diuse hair loss. Aim of the Study The aim of this study was to evaluate the safety and ecacy of Hairzone solution in diuse hair loss.
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Material and Methods The present study was an open clinical trial conducted at Skin-a-Health Centre, Hooghly, West Bengal, India. The study protocol, case report forms, regulatory documents, product information and informed consent forms were submitted to the Institutional Ethics Committee and were approved by the same. Individuals who were aged 18 years and above with diuse hair loss and who were willing to give a written informed consent were enrolled in the study. Individuals on immunosuppressive drugs, with evidence of skin infection and who had used any other topical therapy for diuse hair loss in the two weeks prior to the initiation of the study were excluded. Pregnant and lactating women and those who were not willing to give the written informed consent were also excluded from the study.
Study Procedure

A total of 28 patients (13 men and 15 women), with a mean age of 28.18 10.45 years, were included in the study and their demographic medical histories (including local fungal infection, dandru, pediculosis, trichotillomania, stress, diet, past illness and drugs) and treatment details were recorded. The mean duration of hair loss in these patients was 15.36 12.76 months ranging from three to 28 months (Table 1). The patients underwent a thorough clinical and scalp skin examination (which included assessment of number of hairs lost in one-minute combing test and presence of alopecia patches). At entry, 15 patients presented with dandru, one with pediculosis and 18 with itching; 10 patients presented with jaundice (Table 2). All the patients were advised to gently massage the solution on to the entire area of the scalp, leave it overnight, and rinse it in the morning. Response to the therapy was evaluated at entry and at the end of six weeks. Criteria for evaluation included parameters such as moisturizing eect and reduction in hair fall
Table 1. Demographic Data of Patients on Entry (n = 28)
Parameter Age in years (mean SD) Sex ratio (M:F) Diet (veg:mixed) Duration of illness (months) Hairzone solution 28.18 10.45 13:15 20:08 15.36 12.76

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Table 2. Precipitating Factors
Factor Local factors Dandruff Pediculosis Itching Systemic factor Jaundice Number of patients 15 1 18 10

Results Results of the study showed that most patients treated with Hairzone solution responded well to the therapy. Mean hair fall reduced signicantly from 96.25 50.86 (before treatment) to 38.75 32.44 (after six weeks of treatment; p < 0.0001). Itching disappeared in all the 18 aected individuals and moisturizing eect was appreciated by 25 patients after six weeks of treatment, both with a signicance of p < 0.0001. An improvement in scalp condition, which includes clinical parameters such as pediculosis, dandru, denuded patches and epidermal changes, was observed in all the 28 enrolled patients after six weeks of treatment with a signicance of p < 0.0001 (Table 3 and Fig. 1). None of the patients reported edema, erythema, pruritus or burning sensation on rst as well as on continued application of the solution. No signicant adverse eects were either reported or observed during the entire study period and the overall compliance to the treatment was good. Discussion Diuse hair loss can aect both sexes at any age. Triggers that interrupt the normal hair cycle, such
Table 3. Evaluation of the Effect of Hairzone Solution
Parameters Mean hair fall in 1-minute comb test (mean SD) Itching (number of patients) Moisturizing effect (number of patients) Improvement in scalp condition (number of patients) At entry 96.25 50.86 18 6 weeks 38.75 32.44* 0* 25* 28*

(observed by one-minute comb test) and associated symptoms such as itching and dryness of scalp. 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 predened as Unrelated (does not follow a reasonable temporal sequence from the administration of the drug), Possible (follows a known response pattern to the suspected drug, but could have been produced by the patients 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 patients clinical state). Patients were allowed to voluntarily withdraw from the study, if they experienced any serious discomfort during the study or sustained serious clinical events requiring specic treatment. For those withdrawing from the study, eorts were made to ascertain the reason for dropout. Noncompliance (dened as failure to take less than 80% of the medication) was not regarded as treatment failure, and reasons for noncompliance were noted. All the patients completed the study as planned and their data were available for analysis.
Primary and Secondary Endpoints

The predened primary endpoint was presence or absence of symptoms of diuse hair loss, whereas the predened secondary endpoints were acute and chronic safety, which were assessed by the incidence of adverse events and patient compliance to the therapy.
Statistical Analysis

*p < 0.0001 as compared with at entry values. 120 100 80 60 40 20 0 Mean hair fall in 1-minute comb test 96.25 50.86 *p < 0.0001 as compared to at entry value

* 38.75 32.44 18 * 0 Itching

At entry At end of 6 weeks * 25 0 Moisturizing effect * 28 0 Scalp condition

Values are expressed as mean SD. Statistical analysis was performed by Fisher exact test using GraphPad Prism, Version 4.03 for Windows, GraphPad Software, San Diego, California, USA; www.graphpad.com. The changes in various parameters from baseline values to after treatment values were evaluated by paired t-test. 310

Figure 1. Clinical effect of Hairzone solution.

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as physiologic or emotional stresses, nutritional deciencies and endocrine imbalances, may cause diuse hair loss. Finding the cause or trigger of the hair loss requires knowledge of the patients medical history and a thorough clinical examination. Patient education is the key in the management of diuse hair loss. Management of hair fall is an extremely complex issue. Treatments for various forms of hair loss have limited success with unwanted adverse eects. Hormone therapy, -reductase inhibitors and vasodilators like minoxidil have also been widely used to reduce hair fall.3 Several new technologies in cosmetic transplant surgery and hair replacement are currently available. Results of the present study showed that Hairzone solution, containing herbal extracts of B. monosperma and B. parviora, is eective in the management of diuse hair loss. Both B. monosperma and B. parviora inhibit hair follicular degeneration and extend the anagen phase of the hair growth cycle; they also enhance proliferation and maturation of precursor epithelial cells of the nal hair strand. Also, these herbs prevent the massive apoptosis in the proximal hair bulb and help in the multiplication of hair ber cells with the stimulation of anagenic phase, reducing the catagenic and telogenic phases.8 B. monosperma displays antifungal activity against Cladosporium cladosporioides.9 It also has a signicant bactericidal eect,10 potent antiviral activities11 and astringent action,12,13 which tends to shrink or constrict body tissues locally after topical medicinal application. The herb is also found to possess free radical scavenging activity.14 B. parviora possesses antimicrobial action.15 Therefore from the above ndings, it can be concluded that the clinical ecacy of Hairzone solution in the management of diuse hair loss is due to the synergistic actions of its potent herbs. Conclusion The present clinical study clearly demonstrated the benecial eects of Hairzone solution in diuse hair loss as evidenced by parameters such as moisturizing eect and decrease in hair fall and associated symptoms such as itching and dryness of scalp. No signicant adverse eects were either reported or observed during the entire study period and the overall compliance to the treatment was good. Therefore, it can be concluded that Hairzone solution is clinically eective and safe in the management of diuse hair loss. References
1. Girman CJ, Hartmaier S, Roberts J, Bergfeld W, Waldstreicher J. Patient-perceived importance of negative eects of androgenetic alopecia in women. J Womens Health Gend Based Med 1999;8(8):1091-5. 2. Birch MP, Lalla SC, Messenger AG. Female pattern hair loss. Clin Exp Dermatol 2002;27(5):383-88. 3. Takashima I, Montagna W. Studies of common baldness of the stump-tailed macaque (Macaca speciosa). VI. The eect of testosterone on common baldness. Arch Dermatol 1971;103(5):527-34. 4. Bergfeld WF, Mulinari-Brenner F. Shedding: how to manage a common cause of hair loss. Cleve Clin J Med 2001;68(3):256-61. 5. Price VH. Treatment of hair loss. N Engl J Med 1999;341(13):964-73. 6. Rook A, Dawber R. The comparative physiology, embryology and physiology of human hair. In: Diseases of the Hair and Scalp. Blackwell Science Publications: Oxford, UK 1982:1-7. 7. Rushton DH, Norris MJ, Dover R, Busuttil N. Causes of hair loss and the developments of hair rejuvenation. Int J Cosmet Sci 2002;24(1):17-23. 8. Rawal R, Kolhapure SA. Evaluation of the ecacy and safety of Hair Loss Cream (PCPB Hair Cream) in the management of Telogen euvium. Indian J Clin Pract 2005;16(5):19-26. 9. Bandara BM, Kumar NS, Samaranayake KM. An antifungal constituent from the stem bark of Butea monosperma. J Ethnopharmacol 1989;25(1):73-5. 10. Mehta BK, Dubey A, Bokadia MM, Mehta SC. Isolation and in vitro antimicrobial eciency of Butea monosperma seed oil on human pathogenic bacteria and phytopathogenic fungi. Acta Microbiol Hung 1983;30(1):75-7. 11. Yadava RN, Tiwari L, O Kuntze. A potential antiviral avone glycoside from the seeds of Butea monosperma D. Kuntze. J Asian Nat Prod Res 2005;7(2):185-8. 12. Chopra RN, Nayar SL, Chopra LC. Butea monosperma. Glossary of Indian Medicinal Plants. National Institute of Science Communication, New Delhi 1996;4:42. 13. Asolkar LV, Kakkar KK, Chakre OJ. Butea monosperma. Glossary of Indian Medicinal Plants with Active Principles (second supplement). CSIR Publication, New Delhi 1992;Part I(A-K):148. 14. Lavhale MS, Mishra SH. Evaluation of free radical scavenging activity of Butea monosperma Lam. Indian J Exp Biol 2007;45(4:)376-84. 15. Asolkar LV, Kakkar KK, Chakre OJ. Butea parviora. Glossary of Indian Medicinal Plants with Active Principles (second supplement). CSIR Publication, New Delhi 1992;Part I(A-K):149.

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