Abstract

Hair loss is a common problem in men and women occurring mainly due to nutritional deficiencies, and, the correct diagnosis of hair disorders is complex. Nutritional deficiency may impact both hair structure and hair growth equally in males and females. Vitamin A, E, C, B6, B12, biotin, and folic acid play a crucial role in hair health. Hair loss is often associated with poor scalp health and related complaints like greying of hair, dandruff, dry and damaged hair. Hair loss also associates with low self-esteem. There is a great need for nutritional supplements correcting the need for vitamins to maintain hair health. The aim of the study to evaluate clinical benefits of Power gummies: hairand nail vitamins contains a balanced blend of required vitamins with minerals like zinc and iodine in hair and nail health.

Introduction & Background Information

Hair is considered to be a sign of beauty and youthfulness in society. It is normal to lose about 50-100 hair strands a day. It goes unnoticeable as there are about 100,000 hairs on the head and such a small loss is usually not considered. But there is a problem when the new hair is not replaced by the hair that has been fallen out and the balance of hair loss and hair growth is not maintained. This condition is termed as hair loss. Hair loss can develop gradually over years or can happen abruptly and can be temporary or permanent. [1,2] Depending upon the causative factor, hair loss may be non-scarring or alopecia. When the scalp appears normal with plenty of empty hair follicles is called non-scarring hair loss.[3] While, when the damage to the hair follicles is permanent it is termed as cicatricle alopecia.[4] The causal factors of hair loss are a family history of balding, physical or chemical damage, hormonal changes, significant weight loss, certain medical conditions, stress, and poor nutrition and deficiencies.[5] Vitamin A, Vitamin D, Vitamin C, Vitamin B6, Vitamin B12, Vitamin E, Biotin, Folic Acid, etc. plays a major role in developing healthy and strong hair and also promotes hair growth. The deficiencies of these nutrients often lead to hair loss, brittle nails. Various measures are available to balance the nutrition level by exogenous administration of several supplements. Various medical treatments are available to prevent hair loss like antiandrogenic medications, Minoxidil, finasteride, etc.[6,7] Long-term use of such drugs can lead to complications associated with them and short term use may produce a transient benefit. The currently available dietary supplements which are in conventional dosage forms are found with poor consumer compliance and thus treatment adherence. This in turn can decease the outcomes and improvement in hair growth.

Thus, with an intention of developing a novel product to treat alopecia (hair loss), Aesthetic Nutrition Pvt. Ltd. has come up with Power gummies- an innovative, attractive, palatable, effective and safe solution in chewable gummies to deal with hair and nail related complications in males and females.

The present study deals with the evaluation of the safety and efficacy of Power Gummies in male and female subjects with hair and nail-related complications.

Materials & Methods

Materials
Power gummies containing multivitamins like biotin, vitamin A, vitamin D, vitamin C, etc., which helps in hair fall reduction, strengthening of hair with an overall improvement in hair and scalp condition.[8]

Methods
After getting approval from the ethics committee, the study was registered on the CTRI website, the registration number is CTRI/2020/10/028698[Registered on 28/10/2020]. Patients were enrolled in the study only after registration of study on the CTRI website.

The primary objective of the study was to evaluate the efficacy of power gummies by assessing change in the number of terminal hair and vellus hair in the target area of the scalp by Photrichograms, the reduction in the shedding range of the hair in the “60-second hair comb test”, the folliscopic measurement of hair density and hair diameter, and, nail growth and satisfaction scale on nail health. All the parameters were evaluated from baseline to day 90 i.e. the end of the study on each monthly visit.

The secondary objectives of the study were to evaluate the efficacy of power gummies by assessing the improvement in the “Hair Assessment Questionnaire” (Brittleness, thinning, dryness, and damaged hair), to monitor the improvement in the “Modified hair wash test” (Brittleness and hair loss after washing), to observe the “Improvement in quality of hair” (Shininess, roughness, tangling nature, breaking force), to monitor the VAS- Visual analog scale scalp related complaints like itching, dandruff or irritation (Scalp health), to evaluate premature graying of hair by graying severity score (Premature graying), to determine the tolerability of study drug by assessing adverse events, serious adverse events during the study period, and, the global evaluation of overall improvement in scalp and hair.

Inclusion Criteria
Male/ Female subject’s in generally good health and in the age group 18-40 years were included in the study. Subjects willing to give written informed consent and agree to come for a regular follow-up visit. Subjects falling under Grade I-1 to II-1 or frontal of Savin's pictorial grading of female pattern hair loss or under Grade2 to 4A of hair loss severity grade evaluated as per Norwood scale were considered to be included in trials. Subjects willing to abide by and comply with the study protocol and those who have not participated in a similar investigation in the past two weeks were considered in the trials. Subjects with hair complaints of hair fall and hair damage and the ones who were not on crash dieting were included in the study. Subjects who agree not to change the brand of currently used hair color, dye, treatment, etc., if any during the study term, and those who were willing to refrain from any type of hair treatment like head massage, oil application (on the scalp), perming, etc. during the study duration were included. Subjects with dry, damaged, brittle, thin hair, and/or with premature greying of hair by greying severity score between Score 1 (assigned to under 10% grey hair/cm2) to Score 2 (10%–30% grey hair/cm2 ), and the ones with scalp related complaints like itching, dandruff or irritation.

Exclusion Criteria
Subjects who were undergoing hair growth treatment within 3 months before screening into the study were excluded. Subjects having any active scalp disease which may interfere in the study or on treatment for active acne were not considered for the study. Subjects with history or active phase of malignancy and chemotherapy, history of alcoholism, and/ or psychiatric disorder including trichotillomania were excluded. Subjects of the vulnerable population like pregnant, lactating or nursing mothers were excluded from the study. Any subjects from the investigator's viewpoint proved to be unfit for the study were excluded.

Study methodology
After the Ethics committee’s approval, the clinical study was registered on the CTRI website. Subjects of age between 18 to 40 years of age were screened for eligibility criteria. A total of 60 subjects were enrolled in this study and were allocated in two arms with 2 subgroups in each arm. On the screening visit, written informed consent was obtained from subjects as confirmation of participation. Demographic details were recorded. Clinical examination was conducted, medical history and vitals were recorded. They were screened for inclusion and exclusion criteria. During the screening visit and entire study, the subjects were advised to refrain from antioxidant agents, vitamins, anti-inflammatory drugs, hormones, Nutraceuticals, Ayurvedic, Siddha, Unani, herbal /homeopathic medicines for the maintenance of health. A screening window of 7 days was kept. For nail assessment, after subjects were assigned to groups, they were marked at lunula and observed for 30 days without treatment so effectively 30 days after lunula marking will be baseline visit. Power Gummies treatment was started at baseline day and visit 1 (Day 30 after treatment), visit 2 (Day 60 after treatment) and visit 3 (Day 90 after treatment) was followed for nail and hair assessment. On baseline visit, subjects were recruited based on compliance with the inclusion criteria. They were randomized to respective groups by computer-generated randomization. At baseline and every follow-up visit, they were provided with 70 gummies for use and were advised to consume a dose of 1 gummy twice a day after a meal. They were advised to continue their concomitant medication and a record of the same was kept in the CRF. All the subjects were using a mild shampoo and conditioner for personal care. Compliance of Investigational product was assessed and if consecutively 3 doses were missed or more than 6 days doses were missed during the study period, they were treated as dropouts. They were advised to continue the diet and exercise regimen during the entire study period. After the baseline visit, they were called for follow-up at respective sites after every month for up to 3 months. On every visit, clinical examination was conducted and a trichogram was generated for analysis of their head and scalp. Questions related to scalp hair and nail health were asked and nail examination was also conducted on the baseline, every follow-up visit, and also on the 3rd visit (i.e. day 90). After completion of 3 months of study treatment, an assessment of overall improvement was done. They were closely monitored for adverse effects during the entire study period.

Observation & Results

Study groups and allocation
The study was divided into two groups being Group 1- Female aged between 18-40 years’ sub stratified in age 18-24 and 25-40 years, Group 2- Male aged between 18- 40 years’ sub stratified in age 18-24 and 25-40 years. A total of 60 subjects were included in the study equally divided into groups.

Demographics and Baseline Characteristics
Female and male subjects had mean (SD) ages of 27.86 (6.79) years and 28.32 (6.47) years, respectively, which were not significantly different. There were 2 subjects (One male and one female subject) which got dropped out of the study as could not follow up. Both the groups did not demonstrate any significant differences in lifestyle attributes or baseline mental attitude qualities.

Changes in Hair Density
In the present study, the hair density was measured with a phototrichogram in a 1 sq. cm area. The hair density (sq. cm) in females at baseline, Day 30, Day 60, and Day 90 was 337.59, 338.11, 344.17, and, 408.79 respectively. The hair density (sq. cm) in males at baseline, Day 30, Day 60, and Day 90 was 279.10, 280.61, 288.97, and, 347.42 respectively. There was a significant increase in hair density in female (21%) and male (24.4%) subjects after treatment with Power Gummies for 90 days. The results are depicted in Graph 1 and the subject’s image in Figure 1.