CEGABA (carboxyethyl gamma-aminobutyric acid), a molecule derived from polyamines, causes an increase in the proliferation of Hybridomas in vitro.

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1 HAIRZON MAIN CHARACTERISTICS INCI: Aqua (Water), Dexapanthenol, Copper, Cegaba, Sodium Hyaluronate,HPMC, Gingko Biloba, Biotine, Caffein, Sodium Benzoate, Sodium Hidroxide, ATP, Leucine, Valine, Arginine, Levoglutamide. Physico-chemical specifications Brown clear liquid with characteristic odor. PH: 7±1 Presentation: amber glass vial Volume: 2 ml Main regenerative antifall properties. CEGABA 10 % (Carboxyethyl gamma-aminobutiryc acid) In studies conducted by Dr. Fusi, The result has been comparatively higher than that from Minoxydil. See Annex 1 CAFEINE: See Annex 2 PEPTIDOS DE COBRE (Copper Peptide). See annex 3 ANNEX 1 CEGABA Study. CEGABA as a growth factor. (Professor Fussi) The CEGABA activity as a promoter of cell growth has been demonstrated in several studies carried out first by Curti and Fussi, and later by G.Forni and J. Guardiola. A study published in the Journal of Immunological Methods by Cerino A, de Amici M, Fussi FF, AStaldi Ricotti GC, about CEGABA as a growth factor for hybridomas, achieved the following conclusions. CEGABA (carboxyethyl gamma-aminobutyric acid), a molecule derived from polyamines, causes an increase in the proliferation of Hybridomas in vitro. Compared to other growth factors, the effects and mechanism of action of CEGABA and CR- ECGS (endothelial cell growth supplement) on Hybridomas growth are of a similar nature. info@dermica.ch Page 1

2 However, both factors are less effective than HECS in inducing growth of hybridoma through every step of hybridoma production, including: recovery after the merger, donation and proliferation. This shows that they can act as growth factors in a general and less specific way than in the case of HECS. This in vitro study, shows the stimulation capability of cell growth and the prolongation of long term survival induced by CEGABA, that it is nevertheless not affected by other problems caused by polyamines such as the high concentrations required to achieve significant cell growth rates. Thanks to its activity as a Growth factor, CEGABA is able to stop and reverse the hair fall. (Scientifically tested). CEGABA has a direct effect on the production of cells in culture, thus it is thought that its mechanism of action directly affects to cells of the dermal papillae or germinal matrix. Through a series of non-hormonal mechanisms it prolongs and activates the hair growth phase, it strengthens the hair follicles making them more resistant and it reduces the amount of sebum and dandruff on the scalp. This makes the hair lasts longer, grows ever stronger and thicker and prevents the death of the follicles. It can be applied in different types of alopecia since its mechanism of action involves the stimulation of cell growth. In addition it is also indicated for women andit does not cause any secondary or side effects. FIRST SERIES OF STUDIES ABOUT EFFICACY OF TREATMENT WITH CEGABA. 1. PROCEDURE The tests were conducted in subjects from different social and cultural background. During the preliminary interviews those subjects who seemed to be too worried about their hair characteristics were rejected. Some of the subjects where explained the scientific basis of this study, while the rest were not given any technical explanations. 2. MATERIALS A cosmetic formula with the following ingredients was used: CEGABA (1gr.) Ethanol 7,5 cc. Propileneglicol 1cc Parfume Dye Water info@dermica.ch Page 2

3 3. FRECUENCY AND MANAGEMENT OF TREATMENT A daily friction in males, and controls every 15 days. A weekly friction in women and controls every month. 4. RANGE AND CLASSIFICATION OF TESTS It was not considered appropriate to include in the study, patients with well-known and specific scalp disease, but only subject with the following features: a) Subjects with incipient alopecia (18 to 30 years) even with an intense daily fall b) Subjects with a marked baldness (45 to 60 years) to verify the possible activity of hair strengthening and consolidation of the existing hair. e) Subjects with hormonal unbalance such as menopause, which could be responsible for the fall and thinning hair (women aged 50 to 60 years) 5. RESULTS We obtained very good results in the group of men from 18 to 30 years where 4 out of 5, showed a remarkable response to the treatment (irrespective of the high percentage of subjects who did not attend the controls). In the female group excellent results were also obtained; in this case, and in all cases except for four women who did not attend the controls, as first result we obtained a stop in the hair loss (objective data) and also all of them commented on having noticed an increase in capillary volume and a thickening of the hair, 'which was confirmed by their hairdressers. In two cases there was considerable growth of new hair in the temple area, which was easily verifiable since both subjects had undergone a process of dyeing or bleaching hair. Results were less evident in the group of men aged 45 to 60 years. Only 5 subjects in a group of 9 (one of them did not attend the control) commented having noticed a strengthening of the hair and 3 of them proved these effects with objective data. The other four subjects indicated a reduction in hair loss as much as strengthening in the hair impression. It should be noted that this group was the most difficult to control objectively. In none of the cases intolerance or allergic reactions appeared. info@dermica.ch Page 3

4 SECOND SERIES OF STUDIES ABOUT EFFICACY OF TREATMENT WITH CEGABA. The study was conducted on 10 subjects who followed a topical therapy consisting of a hydroalcoholic lotion with CEBAGA in proportions of 1.1 to 3%. In the wash it was also used CEGABA by a percentage of 1.1%. The results of the study are: 1) Stimulation of the follicle 2) Reduction of hair loss 3) Normal Formation of anatomical structure of the hair After topical therapy followed with CEGABA, in lotion and washes form, no secondary effects were appreciated. info@dermica.ch Page 4

5 THIRD SERIES OF STUDIES ABOUT EFFICACY OF TREATMENT WITH CEGABA. 1. SUMMARY The study carried out in 40 subjects treated with CEGABA compared with minoxidil formulation, the capacity of both products of strengthening hair and improving the condition of the scalp in 100% of cases was demonstrated. Regarding hair loss, CEGABA formula stopped it in 93% of cases, whereas MINOXIDIL was effective in only 57% of cases. This is probably due, among other things, to the fact that Minoxidil works more slowly than CEGABA. So we should wait for the tests after 360 days of treatment to be completely reliable. The objective evaluation of new hair growth was very difficult to carry out as all subjects (both CEGABA as minoxidil) were very satisfied and commented on having noticed hair growth. We report, therefore, only as positive cases those in which there were observed where an unequivocal growth of new hair. Both products provided similar positive results (28.5% MINOXIDIL and 29% CEGABA). Note that almost all the cases that have reacted positively to the CEGABA, have expressed their effects on the third control whereas those with MINOXIDIL noticed only at the fourth or fifth control. However, it may be possible that long-term results with Minoxodil could be higher on a perceptual basis. On the other hand, the disadvantage with MINOXIDIL occurs when tangible results start, which becomes to disappoint participating subjects. In fact, 31 subjects under treatment with CEGABA attended the control while just 5 with MINOXIDIL, who were 17 to the second control and 14 to the third. 2. RANGE AND CLASSIFICATION FOR TESTS 40 individuals were chosen for each product divided into the following subgroups: 10 men aged 30 and older with problems of hair loss and alopecia 10 men from 18 to 30 years with problems of hair loss and alopecia 10 women from 17 to 50 years with hair loss problems and hair fragility 10 women over 40 with hair thinning and scarcity of it. 3. MANAGEMENT AND FREQUENCY OF TREATMENT Head must be rubbed every other day with 5 to 10 cc according to hair volume and controls must be performed every 30 days. 31 subjects underwent the final control of CEGABA and 34 the MINOXIDIL one. info@dermica.ch Page 5

6 4. RESULTS Hair strengthening MINOXIDIL: In the first control (after 30 days of treatment) 4 individuals showed some improvement while 21 did not notice any results. In the second control (60 days) other 5 subjects noticed an improvement while 8 remained without seeing any results. In the third control (90 days) 14 subjects appreciated the improvement. In the final control (6 months) 14 subjects were satisfied. In the first control (30 days) 30 subjects noticed a marked improvement in the general conditions of the scalp and hair, with a reduction of seborrhea and dandruff and a better grip of the scalp hair. In the second control (60 days) all subjects (31) noticed the improvement. In the final control, (6 months), 31 were satisfied HAIR LOSS DETENTION MINOXIDIL: In the first control 1of the subjects appreciated a stop in hair loss. The other 24 subjects did not appreciate any results. In the second control another 3 subjects reported a decrease in the fall and another 13 remained without seeing results. In the third control another 4 noticed that hair loss stopped and 6 of them continued without seeing any results. In the final control 8 subjects from the 14 considered solved the problem of the fall. The remaining 6 reported an overall improvement. CEBAGA In the first control 27 subjects reported that their hair loss had stopped. In the second control another 2 subjects appreciated this stop. In the final control 29subjects declared the problem of hair falling solved and another 2 reported having experienced a hair strengthening. info@dermica.ch Page 6

7 NEW HAIR GROWTH MINOXIDIL In the first, second and third control not any signs of hair growth were observed and in the fourth control a woman showed signs of growth in the temporal area. CEGABA In the third control, 10 subjects showed positive results, with hair growth in areas prone to be hairless (temples and crown). All subjects were satisfied with the treatment and noticed a strengthening of the hair. The results of the treatment depended largely on the location and extent of the alopecia as well as on the age and sex of the subjects. Women and subjects under 40 with bald areas less than 10 cm in diameter were those with the best response to treatment. Also unlike minoxidil, topical formulation with CEGABA is well tolerated and produces no adverse skin reactions such as itching, erythema, desquamation, hypertrichosis, burning,, eczema and hair loss. ANNEX 2 CAFEINA CAFFEINE Caffeine has been identified as a stimulator of human hair growth in vitro, and reduced testosterone-induced follicle growth suppression. It has been demonstrated that the addition of caffeine to a shampoo-formulation is effective in administering caffeine to the hair follicles in the scalp. Further research must be done to evaluate the efficacy and adequate dosage of caffeine in the treatment of androgen etic alopecia. A spray made with coffee beans is claimed to prevent age-related hair loss in women. ANNEX 3 COOPER PEPTIDES As it is well known, during youth hair is abundant and the hair follicles are well supplied by blood vessels. However, during aging, it is been verified that the process of follicles regeneration, abundantly irrigated before, starts to slow down. In a man, the action of the hormone dihydrotestosterone (the major responsible for male baldness pattern) represents an added obstacle to the growth of hair. It is also known that the effect of the process of miniaturization of hair follicles leads to a progressive baldness with always more superficial hair and less irrigated by blood. The direct consequence of this progressive "diminishment" of the hair bulb leads toa growth of always info@dermica.ch Page 7

8 thinner and more fragile hair and without pigmentation. What is the use of copper peptides to combat baldness? Copper peptides, patented by Loren Pickart in the 80's, thanks to its many virtues, are among the substances that contribute best to lock or revert the process of miniaturization of the follicles. According to Pickart the processes of renewal of the skin and scalp are made through hair follicles, as new skin cells emerge from the hair follicles and migrate to the skin of the regions that surround them. Pickart states that the action of copper peptides would be able to reverse the natural aging process of skin and hair follicles, characterized by fine, miniaturized hair, thinner scalp and longer telogen phases. Among the causes of accelerated aging skin and hair processes, chemical factors and / or environmental factors such as the action of chemical and cosmetic stains, excessive exposure to heat and ultraviolet rays damage the scalp other nature (scar) and autoimmune action of the body have also been also mentioned. It was noted that the action of copper peptides would revert those natural processes, leading to the generation of new blood vessels around the follicle, as well as to an increase of subcutaneous fat and melanin synthesis, beyond the damage to regenerate scalp, promoting the formation of thicker hair. These effects were first observed in the 40's during the Second World War, when it was verified as a prognosis device in the cure process of patients affected by grave burns and scars. Observation of the hair follicles apart from the burnt skin became determinant since if the follicles tended to widen the cure would be scarce and the scars would remain. Later, in 1985, Pickart found that not only did his copper peptides, the SRCPs (Skin Remodeling Copper Peptides) stimulate the healing of wounds, but they also increased the size of hair follicles in areas hit by them. Therefore it was concluded that apart from being growth stimulators in themselves, this growth driven by copper peptides represents a natural consequence of increased vitality and health of the hair follicle. Copper peptides complement the hair transplant to stimulate the conversion of fine hair in pigmented hair thicker and, through its action on the hair follicle. info@dermica.ch Page 8