1 Hair loss prevention and hair regeneration study Report of the findings of the clinical trial to evaluate the effectiveness of VR6 hair treatment Study conducted by: Centro de Tecnología Capilar, SL Report written by: Dr. Javier Morán It works
2 2 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY Table of contents 1. Hair problems 3 2. Stages of hair growth 4 3. Study data Objective 3.2 Subjects 3.3 Material 3.4 Methods 4. Findings of the study Evolution of hair in pictures 4.2 Studies of hair growth and reduced hair loss 4.3 Hair density 4.4 Micro-photographs representative of hair density 4.5 Bulb photographs 5. Conclusions 14 Report no.: 0247/14 Conducted by: Centro de Tecnología Capilar (Barcelona) Monitored by: Quantum Experimental (Murcia) Supervised by: San Antonio Catholic University (UCAM, Murcia) Directors of the study: Eni Gómez (CTC) and Javier Morán (UCAM) Clinical coordinator: Isabel Vasallo (Quantum) Head of product evaluation: Marta Lladós (CTC) Specialists: Danna Millán and María Jesús Rodríguez (CTC) Promoter of the study: CNCE Innovación, S.L. Product: VR6 Definitive Hair (capsules and foam) Start of study: 20 October 2013 End of study: 30 April 2014 Delivery of the findings: 22 May 2014 Design and layout: Publitesa Comunicació All rights reserved. Total or partial reproduction is prohibited without the corresponding permission.
3 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY 3 1. Hair problems The incidence of hair problems has increased in recent decades. The stress of everyday life, along with nutritional deficiencies caused by unbalanced diets and other factors (such as hormonal ones, for example), has increased the incidence of hair problems in the general population and particularly in women. Hair has great psychosocial importance for human beings, so its loss may not just pose an aesthetic problem, but also lead to selfesteem issues. VR6 capsules 100% natural dietary supplement Hair loss is often trivialized, but it may have profound effects on the well-being and quality of life of patients affected by it. In fact, when such people do not receive from their doctor what they consider to be appropriate treatment, they usually end up trying remedies that are not proven effective but are nevertheless for sale. Changes in hair may be due to morphological modifications to the hair shaft or alterations to the bulb related to the biological cycle. Hair growth occurs cyclically and asynchronously. Therefore, around 85% of hair is in the growth stage, while 2% is at rest and 13% is in the loss stage. There are several factors that may damage hair structure and development. These factors include the continuous use of products with compositions aggressive to hair, nutritional deficiencies and hereditary, endocrine and autoimmune issues. Any of these factors may cause widespread hair loss, a loss of shine and silkiness, a reduction of hair thickness, greater ease of breaking and an increased tendency towards diffuse alopecia. VR6 Foam Hair regenerator for 1 month VR6 Foam Hair regenerator for 3 months
4 4 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY 2. Stages of hair growth It is important to remember that the anagen stage is when hair grows and the telogen stage is when hair falls out. Considering these assumptions, products will have positive results if they increase hair during the anagen stage and reduce its loss during the telogen stage. The anagen stage is when the hair follicle actively grows and there is constant mitosis of the cells in the matrix. This stage lasts between 2 and 6 years in the scalp depending on different variables like an individual s age, diet and health status. The catagen stage is a brief, two-week transition between the anagen and telogen stages. Cell division that led to hair growth stops and the bulb is choked off. The telogen stage is when hair falls out. It lasts approximately three months. Dead hair remains in the follicle until a new hair grows and dislodges it, causing it to fall out. Hair grows around 0.35 mm per day, which comes out to around cm each year. There are around 350 follicles per cm 2 on the scalp.
5 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY 5 3. Study data 3.1 Objective There are currently no treatments that have proven effective in the prevention and treatment of these types of hair problems associated with hormone deficiencies or stress, so it would be interesting to develop specific products. Given this situation, the aim of this study is to verify the effects of the dietary supplement (VR6 capsules) developed from natural products on hair thickness and strength and the decrease of hair loss in a sample of men and women that presented hair problems with increased hair loss. The main objectives were to investigate whether or not the daily administration of a dietary supplement (with or without anti-hair loss foam) reduces hair loss in the three groups of the study and to see if hair regeneration occurs in any of them. 3.3 Material VR6 capsules contain a hair-activating dietary supplement that provides concentrated plants and nutrients presumably related to improvements of factors that alter proper hair growth. The innovative formula of this 100% natural supplement contains a combination of different active ingredients such as zinc, biotin, vitamin B6 and L-Cysteine. 3.2 Subjects Sixty-two volunteers aged between 18 and 60 participated in the study. Patients of a hair clinic located in Barcelona, they were recruited by its staff. All participants in the study had to present diagnosed hair problems, defined as a loss of hair thickness or volume or an increase in hair loss below what is considered alopecia (the loss of over 200 hairs per day). The groups subject to the study included: Group 1 (VR6 capsules), with 22 volunteers (10 men and 12 women); Group 2 (placebo), with 20 volunteers (5 men and 15 women) and Group 3 (VR6 capsules plus VR6 anti-hair loss foam), with 20 volunteers (7 men and 13 women). Each volunteer involved in the study was assigned a number according to their order of entry into the study, which belonged to one of the three groups. At no time did either the researchers or the participants find out to which group they belonged. The study spanned 180 days (6 months), with tests conducted at the first study visit (T0), at 90 days (T90) and at 180 days (T180). VR6 foam acts through seven key mechanisms that can reprogram the lifecycle of hair and deactivate the factors that cause its premature loss. Through this procedure, the hair root gradually receives better nutrition and becomes stronger, ensuring hair growth and regeneration. One of the main ingredients is Anagain, which reprograms the lifecycle of hair, activates and prolongs the anagen stage and shortens the telogen stage.
6 6 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY 3.4 Methods 1. General photograph of the scalp In the visits held at T0, T90 and T180, various photographs were taken of the upper part of the scalp. The images showed the receding hairlines and the vertex (crown) of all the volunteers. The aim was to check whether the VR6 products under study manage to increase hair density to the point that it is noticeable at first glance. 2. Observation and photographs via a micro-camera. The micro-camera calculates the number of hairs per unit of surface area or hair density. When images obtained at the beginning and end of the study are compared, the effectiveness of the VR6 product under study may be evaluated. 3. Trichogram. This consists of plucking a certain number of hairs from the scalp in order to determine the current stage of the hair growth cycle, as well as the initial and final appearance of the hair bulbs. The trichogram is a snapshot of the status of the hair roots and bulbs, and therefore of the scalp at any given time. Depending on the results, it reveals whether the hair renews normally or if there is any alteration in the hair cycles 4. Hair density. This is defined as the number of hairs present in a unit of surface area (cm2, generally). The increase in hair density at the end of the study is highly valuable evidence for demonstrating the effectiveness of the dietary supplement (VR6 capsules). The number of hairs present per unit of surface area is calculated from the images of the scalp taken with the TrichoScan micro-camera at the beginning (T0), middle (T90) and end of the study (T180). 5. Photograph of the bulbs. The photograph of the bulbs of the hairs plucked out to perform the trichogram helps to confirm the results of the trichogram and to visualize the hair bulbs at the beginning and end of the study, as well as to check its effectiveness in their appearance and development. 6. Combing test. This determines the number of hairs shed during hairstyling in standard conditions. After using the products under study, the number of hairs lost when combing is intended to be less than at first. 7. Wash test. This determines the number of hairs lost while washing the hair in standard conditions. After using the products under study, the number of hairs lost when washing is intended to be less than at first. 8. Volunteer assessment survey. The volunteers evaluate the perceived effectiveness of the products at the midway point (T90) and end of the study (T180). The assessment is collected in the surveys created for this purpose.
7 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY 7 4. Findings of the study 4.1 Evolution of hair in pictures The results of some of the volunteers of the different groups may be seen in the photographs below. Group 1 (VR6 capsules) T0 T90 T180 Group 2 (placebo) T0 T90 T180 Group 3 (VR6 capsules + anti-hair loss foam) T0 T90 T180
8 8 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY 4.2 Studies of hair growth and reduced hair loss Below are different graphs linked to hair growth and loss along with an explanation of the pertinent findings. _Relationship between the anagen and telogen stages Average ratio between the anagen and telogen stages of the groups in the study (VR6 capsules, placebo and VR6 capsules + foam) measured at the beginning of the study (T0), after 90 days (T90) and after 180 days (T180). This analyzes the relationship between the number of hairs in both stages. These are the most important points to consider in the graph above: A significant boost in the anagen/telogen ratio in the VR6 capsule group and in the group also using the foam. After 180 days of the study, the results between the VR6 capsules + foam and placebo groups differed significantly, with higher values obtained by the group using the VR6 capsules and foam. The placebo group experienced no increase in the anagen/telogen ratio. Average 3,5 3 2,5 2 0 days 90 days 180 days The daily use of VR6 capsules has a positive effect on the proportion of hairs in the anagen stage and in the telogen stage. VR6 capsules + foam VR6 capsules placebo _Percentage of hairs in the anagen stage Average percentage of hairs in the anagen stage of the study groups (VR6 capsules, placebo and VR6 capsules + foam) measured at the beginning of the study (T0), after 90 days and after 180 days (T180). Average % These are the most important points to consider in the graph above: Both the group that received VR6 capsules and the group that received VR6 capsules + foam presented an increase in the percentage of hairs in the growth stage based on the time that the study lasted. The individuals in the placebo group showed no change over time in the percentage of hairs in the anagen stage. The effect of the VR6 capsules is positive from the outset. And by using the VR6 capsules and the foam, the effect is seen after 90 days days 90 days 180 days VR6 capsules are effective in fostering hair regeneration after 90 days of use. VR6 capsules + foam VR6 capsules placebo
9 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY 9 _Percentage of hairs in the telogen stage Average percentage of hairs in the telogen stage of the study groups (VR6 capsules, placebo and VR6 capsules + foam) measured at the beginning of the study (T0), after 90 days and after 180 days (T180). Average % days 90 days 180 days These are the most important points to consider in the graph above: The individuals that received the placebo showed no variation over the course of 180 days of use, with the number of hairs in the final stage of the growth cycle remaining nearly constant. The individuals that took the VR6 capsules presented a statistically significant drop in the percentage of hairs in the telogen stage after 90 and 180 days. Less hairs in the telogen stage were observed in the group of people that took the VR6 capsules and foam between 90 and 180 days. VR6 capsules + foam VR6 capsules placebo In addition to enhancing hair growth, the VR6 product reduces hair loss after 90 days of use.
10 10 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY _Increase in the percentage of hairs in the anagen stage Average increase in the percentage of hairs in the anagen stage of the study groups (VR6 capsules, placebo and VR6 capsules + foam) after 90 and 180 days of use (T90 and T180, respectively). _Reduction in the percentage of hairs in the telogen stage Average reduction in the percentage of hairs in the telogen stage of the study groups (VR6 capsules, placebo and VR6 capsules + foam) after 90 and 180 days of use (T90 and T180, respectively). Increase % Reduction % days 180 days 90 days 180 days VR6 capsules + foam VR6 capsules placebo VR6 capsules + foam VR6 capsules placebo These are the most important points to consider in the graph above: After 90 days of use, the group that took the VR6 capsules showed an increase in the percentage of hairs in the anagen or growth stage (2.01%) and a reduction in the percentage of hairs in the telogen or loss stage (-2.40%). The percentage of reduction in the group that only took the VR6 capsules was double that of the group that also used the VR6 foam (-14.79% vs %, respectively). After 180 days of use, both the group that took the VR6 capsules and the group that took the VR6 capsules + foam showed an increase in the percentage of hairs in the anagen stage and a drop in the percentage of hairs in the telogen stage.
11 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY Hair density The increase in hair density was calculated for each study group during the first 90 days of use and at the end of the study (after 180 days). _Increase in hair density Average increase in the hair density (%) of the study groups (VR6 capsules, placebo and VR6 capsules + foam) after 90 and 180 days of the study (T90 and T180, respectively). These are the most important points to consider in the graph above: After 90 days of the study, there was a positive increase in hair density in the group that took the VR6 capsules + foam.. After 180 days of the study, these was a statistically significant increase in hair density compared with the results after 90 days in the group that took the VR6 capsules (11.13%) and the group that took the VR6 capsules and applied the foam (17.22%). Evolución The daily use of VR6 capsules produces a positive effect in the increase of hair density and the size of the increase depends on the duration of use days 180 days VR6 capsules + foam VR6 capsules placebo Hair density refers to the amount of hairs in a specific space. In the study, hair density was measured by cm 2.
12 12 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY 4.4 Micro-photographs representative of hair density The results of some of the volunteers of the different groups may be seen in the following photographs. Group 1 (VR6 capsules) T0 T90 T180 Group 2 (placebo) T0 T90 T180 Group 3 (VR6 capsules + anti-hair loss foam) T0 T90 T180
13 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY Bulb photographs At T0, the images selected for Group 1 (VR6 capsules) show small, scarcely developed roots in a late anagen stage, typical of hair loss processes. At T90, no significant differences are observed in the morphology of the roots or in the hair stages. However, at T180, a clear improvement in the hair s morphology, activity and size may be seen. In Group 2 (placebo), none of the images analyzed show differences regarding the beginning of the treatment. The anagen stages show no anatomical differences at T90 or at T180 when compared with T0. In Group 3 (VR6 capsules + foam), differences are detected between the start and end of the treatment. At T0, the anagen stage appears relatively inactive and tends towards the telogen stage, as occurs in hair loss processes. At T90, a slight improvement is seen compared with T0 and at T180, the hair roots have increased in size, are more developed and show greater cellular activity. Group 1 (VR6 capsules) T0 T90 T180 Group 2 (placebo) T0 T90 T180 Group 3 (VR6 capsules + anti-hair loss foam) T0 T90 T180
14 14 HAIR LOSS PREVENTION AND HAIR REGENERATION STUDY 5. Conclusions The use of VR6 capsules is effective in managing the proportion of hairs in the anagen or growth stage and hairs in the telogen or loss stage. When VR6 foam is applied, this ratio is statistically significant compared with the placebo. The daily use of VR6 capsules, either with or without foam, increases the percentage of hair in the growth stage. This increase occurs more noticeably after 90 days. The use of VR6 capsules lowers the percentage of hairs in the loss stage. For the group that also applied the VR6 foam, this reduction becomes even more visible between 90 and 180 days. After 180 days of use, there is a representative rise in the percentage of hairs in the anagen stage and a reduction in the telogen stage, both for the VR6 capsule group and the group using the VR6 capsules and foam. This increase in hair density could be seen objectively in the micro-photographs representing hair density. Wash and combing tests are the first tests performed to determine the effectiveness of a hair product. However, this study did not view them as determinative or reliable tests, since it is very difficult to standardize the conditions for measuring the results. In brief, daily use of the dietary supplement (VR6 capsules) improves the anagen/telogen ratio of hair (by increasing hairs in the anagen stage and reducing hairs in the telogen stage). This is related to the simultaneous use of the foam and the duration of use, which fosters hair regeneration and hair growth, especially after 90 days of use. This growth can be seen in the increase in hair density measured by micro-cameras. The size of this increase depends on how the foam is used and for how long. An important increase in hair density is observed in the VR6 capsules + foam group after 90 days, and in both groups that continued to take the dietary supplement after 180 days. From the study s findings, we may conclude that the use of VR6 capsules was 88.36% effective. This figure rose to 92.46% when both VR6 capsules and foam were used.
16 The first and foremost hair treatment for men and women CNCE INNOVACIÓN, S.L. Consell de Cent, , 5º 2º Barcelona (SPAIN) For further information: (+34)
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