Abstract

Objective: The present questionnaire-based study aimed to investigate the clinical experience and treatment patterns of Sebamed® anti-hair-loss shampoo usage among patients with complaints of hair loss in real-world Indian settings.

Materials and methods: An observational real-world, case- and questionnaire-based survey was conducted at 47 sites in Indian healthcare centres having medical records of patients with hair loss who had received Sebamed® anti-hair-loss shampoo therapy.

Results: Emotional stress (38.4%), pollution (34.2%) and dietary insufficiency (33.7%) were common risk factors associated with hair fall, followed by sunlight exposure (26.7%), recent childbirth (12.2%), seasonal variations (11.5%) and high fever (6.6%). The patients with complaints of hairfall, majority of them had anti-hypertensive (32.3%) and hormonal therapy (28.5%) as concomitant medications. The majority of patients had excessive hair shedding. Hair-shedding score: (66.9%), while the remaining patients had normal hair shedding Hair-shedding score (33.1%) [1-9]. A total of 146 patients had other anti-hair loss therapy before the initiation of Sebamed® anti-hair loss shampoo. The majority of Healthcare Professionals (HCPs) expressed strong agreement that using Sebamed® anti-hair loss shampoo for 16 weeks led to improved hair growth, thickness, hair fall count and density in patients experiencing normal hair shedding and excessive hair shedding. The overall global assessment for tolerability was good to excellent for a majority of the patients (96.4%).

Conclusion: The Sebamed® anti-hair fall shampoo presents a viable and secure option for managing hair thinning and promoting hair growth.

Keywords: Emotional Stress; Hair Thinning; Shedding Score; Tolerability

Introduction

Hair loss is a widespread biological problem that affects people all over the globe, including India [1]. It is a common dermatological condition that can be caused by various factors, including genetic predisposition, pharmacotherapy, pathological state, nutritional deficiencies and environmental conditions [2-5]. Clinically imperceptible hair loss can impact one’s appearance, attractiveness and personal image, especially in women [6]. It is a traumatic experience correlated with a decreased quality of life [7,8].

Androgenic Alopecia (AGA) or male-pattern baldness, is the main cause of hair loss in both men and women. In contrast, a history of medical conditions such as hypothyroidism and nutritional deficiency and oral contraceptive usage are more common causes of hair loss in women [1,9]. The AGA affects approximately 80% of men with hair loss and 40% of women patients aged below 70 years [11-13]. The incidence of female AGA is gradually rising among young women, which can lead to major physiological consequences. Women may experience a loss of hair density, thinning and broadening of the scalp, particularly in the central region of the scalp [14]. In men with AGA, the hair follicles’ stem cells are retained, but the number of more actively growing progenitor cells decreases [15].

Various treatment strategies with different pharmacological effects to render hair-loss rescue includes topical corticosteroids, immunotherapeutic agents, minoxidil, cyclosporine-A, systemic or local phototherapy, anthralin, interferon-α, photodynamic therapy and acupuncture [16-18]. As per the National Center for Complementary and Integrative Health survey report, more than 30% of adults use non-conventional treatments for hair loss [19]. Hair loss has long been treated with both topical and oral treatments, including vitamins, amino acids and minerals based on natural ingredients.

With the advancement in research approaches, several new aetiologies of hair loss are being discovered. The proper combination of topical cosmetics with a multi-targeted approach could be a potential therapeutic strategy to improve hair regrowth. Moreover, the use of herbal extracts and supplements has increased tremendously because of their fewer adverse effects with better patient compliance [20].

Sebamed® anti-hair loss shampoo is an alkali and soap-free anti hair fall shampoo that contains caffeine and ginkgo biloba extract. It stimulates the blood circulation of the scalp for the optimal nourishment of the hair root to strengthen the hair and its growth. The key features include regeneration of dry, dull and lifeless hair, relieving dry scalp and supporting healthy scalp; regenerating and revitalising hair follicles; relieving scalp tension; repairing cuticles and hair follicles, thus regulating hair loss; relieving itchy scalp; restoring hair, leaving it smooth, silky and healthy; restoring hair elasticity; making hair shiny and lustrous; and increasing hair thickness and volume [21].

Real-world experience to understand the efficacy of Sebamed® anti-hair-loss shampoo in restoring hair loss is required to establish the efficiency of the product. Therefore, the present questionnaire-based study aimed to investigate the clinical experience and treatment pattern of Sebamed® anti-hair-loss shampoo usage in patients with a complaint of hair loss in real-world Indian settings.

Methods and Materials

Study Design

An observational real-world case and the questionnaire-based survey was conducted at 47 sites in Indian healthcare centres (between March 2022 and February 2023) having medical records of patients with hair loss who had received therapy with Sebamed® anti-hair loss shampoo. A standard questionnaire about the usage of Sebamed® anti-hair loss shampoo in patients with a complaint of hair fall in Indian settings was prepared, discussed and validated by the experts.

Inclusion Criteria

Patients of either sex, age above 18 years, who were in general good health and complaining of hair fall and damage, with no known allergies as established by medical history or who do not smoke or consume alcohol were included in this study.

Exclusion Criteria

Patients participating in similar therapeutic trials within the last three months from the commencement of treatment were also excluded from this study.

Data Collection

This study collected patient data from 47 Healthcare Professionals (HCPs) prescribing Sebamed® anti-hair loss shampoo to their patients with hair loss. The objective of this study was to evaluate the demographics of patients receiving Sebamed® anti-hair loss shampoo, risk factors, history, hair-shedding score, standardised hair loss count, hair pull test, management and assessment rating, improvement in hair growth, density, thickness, hair fall count, hair loss and hair structure. Physician global evaluation of efficacy and tolerability were also assessed.

Statistical Analysis

Statistical testing used Statistical Package for the Social Sciences (SPSS) version 23.0. Descriptive statistics were used to describe categorical variables (frequency and percentages) and continuous variables (mean and Standard Deviation [SD] or median and range [depending on the normality of data]). A comparison of qualitative variables between the groups was done using the chi-square test. A P<0.05 was considered statistically significant.

Results

The demographic and clinical characteristics are listed in Table 1. The median age of the patients was 32.0 years (range: 10.0 to 65.0). Emotional stress (38.4%), pollution (34.2%) and dietary insufficiency (33.7%) were common risk factors associated with hair fall, followed by sunlight exposure (26.7%), recent childbirth (12.2%), seasonal variations (11.5%) and high fever (6.6%). Around 36.5% of patients had iron deficiency anaemia, 26.6% of patients were known to have hypertension and 26.6% of patients had a history of diabetes. Other common medical conditions among patients included thyroid disorder (18.9%), postpartum (9.9%), contact allergic dermatitis (7.7%), metabolic disturbance (6.0%) and haemorrhage (1.7%) (Fig. 1). The majority of patients had anti-hypertensive (32.3%) and hormonal therapy (28.5%) as concomitant medications (Fig. 2). The majority of patients had excessive hair shedding [Hair-shedding score: 5-9] (66.9%), while the remaining patients had normal hair shedding [Hair-shedding score: [1-4] (33.1%). A total of 57.4% lose more than 100 strands of hair a day, while 30.4% and 12.1% of patients lose less than 100 and more than 200 strands of hair a day, respectively.

Management and assessment ratings are listed in Table 2. A total of 146 patients were on other anti-hair loss treatments before the initiation of Sebamed® anti-hair loss shampoo. Of these, the majority of patients (68.5%) were treated with minoxidil, 38.4% were given finasteride, 8.9% had spironolactone, 4.8% received corticosteroid injections, 1.4% had peptide treatments and only 0.7% were treated with platelet-rich plasma therapy.

A total of 51.7% of patients used Sebamed anti-hair loss shampoo for 8-12 weeks, while 35.6% and 12.0% of patients used Sebamed anti-hair loss shampoo for 13-16 weeks and 17-34 weeks, respectively. The majority of patients (86.7%) applied Sebamed® anti-hair loss shampoo two-to-three times weekly. Treatment with minoxidil (58.4%), micronutrient supplementation (46.9%), finasteride (25.6%), platelet-rich plasma (17.6%), hair transplant surgery (3.4%), spironolactone (2.7%), microneedling (2.3%), laser therapy (1.8%) and corticosteroids injections (0.9%) was continued with anti-hair loss shampoo. Only 2.0% of patients experienced adverse events after Sebamed® anti-hair loss shampoo treatment.

Tolerability

The overall global assessment for tolerability was rated as good to excellent for the majority of the patients (96.4%). A total of 98.5% of HCPs expressed strong agreement that using Sebamed® anti-hair loss shampoo for 16 weeks led to improved hair growth in patients (Fig. 3). The majority of HCPs expressed strong agreement that using Sebamed® anti-hair loss shampoo for 16 weeks resulted in improved hair thickness among patients (Fig. 3).

Similarly, 98.5% and 91.4% of HCPs strongly concurred that the utilisation of Sebamed® anti-hair loss shampoo resulted in improvement in hair fall count and density, respectively, among patients at week 16 (Fig. 3).

Certain HCPs agreed on the positive impact of Sebamed® anti-hair loss shampoo on hair loss reduction and improved hair structure (Fig. 3).

A total of 98.1% of HCPs agreed or strongly agreed that Sebamed® anti-hair loss shampoo is effective according to physicians’ global evaluation of efficacy (Fig. 3).

Figure 1: Medical history.

Figure 2: Concomitant medications.

Figure 3: Outcome analysis after the initiation of Sebamed® anti-hair loss shampoo a) Improvement in hair growth; b) Improvement in hair thickness; c) Improvement in hair fall count; d) Improvement in hair density; e) Effect on hair loss; f) Effect on hair structure; g) Physician global evaluation of efficacy. Neither agree nor disagree: *n=1; **n=2; #n=3; ##n=4; ***n=12; †n=13; ††n=14; ¥n=20; ¥¥n=21.