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Keywords: alopecia, male alopecia, androgenetic alopecia, serenoa repens, hair lotion, nutraceutical, topical lotion, hair loss, scientific study
MULTICENTER SCIENTIFIC STUDY PERFORMED WITH A NUTRACEUTICAL AND A LOTION IN PATIENTS WITH MALE ANDROGENETIC ALOPECIA
MULTI-CENTER SCIENTIFIC STUDY ON THE EFFECT OF A NUTRACEUTICAL AND A LOTION IN MALE ANDROGENETIC ALOPECIA
Mariuccia Bucci, Luisa Bartalini, Maria Grazia Mannino, Carla Senesi, Franco Faccenda, Francesca D'Anna, Alessia Pini, Antonio Pistone, Maria Guarino, Giuseppe Scarcella, Massimiliano Cametti, and Andrea Romani
Introduction: male androgenetic alopecia
Androgenetic alopecia is a common problem in men, occurring on average between the ages of 35 and 45. This disease has a genetic origin and is caused by the activity of dihydrotestosterone (DHT), which binds to androgen receptors at the follicular level and induces their progressive weakening, until the follicle atrophies, resulting in miniaturization and hair loss. This type of alopecia is expressed by the typical Ludwig’s pattern, which begins at the top of the head and then extends toward the forehead going to join the receding area of the hairline. The presence of the condition is due to the physiological action of testosterone, and the conjunction with apical hair loss often results in a situation of “crown” baldness, in which the hair present in the parietal position and on the nape of the neck is spared from the onset of the problem because it is less sensitive to androgen hormones.
For the treatment of Androgenetic Alopecia it is necessary to go against the action exerted by DHT at the follicular level, so as to prevent follicle fibrosis and its atrophy.
It is also necessary to go to reduce the inflammatory component always present in this pathology: this can be done either with low-dose pharmaceutical compounds for topical use, usually containing cortisone or other corticosteroids, or with the use of specific nutraceuticals and targeted nutraceuticals taken systemically. Topical lotions containing naturally occurring anti-inflammatories can also be used.
The joint action of a nutraceutical and a lotion will be evaluated in this study in order to assess their effects in patients with AGA.
Objective of the study
To evaluate the efficacy of a nutraceutical(Restax® 30softgel+30cps) and a hair lotion(Restax Men’s Lotion 100mL) administered over a 6-month period in the treatment of patients presenting with symptoms of mild or moderate male androgenetic alopecia. The reduction of hair loss, their possible increase in density and diameter was evaluated, the evaluation will be done by means of a form filled out by the physician at time 0 and after 6 months of treatment. In addition, as a secondary end-point, the study aims to evaluate the tolerability of these products for use in chronic therapies.
Materials and methods
Each patient was asked to take 1 capsule of Restax supplement daily during dinner and to apply the lotion every other day for a minimum of 3 times per week, applying 15 sprays to the affected areas, in damp or dry hair that was not necessarily washed before each application. The researcher, after examination and patient history, completed the questionnaire at T0 and T6, assessing clinical symptoms such as pull test result and the presence of trichodynia and itching using a scale of 0 to 3 where 0 indicated the absence of the symptom (and for the pull test 0 indicated negative outcome) and 3 indicated a very strong presence of the symptom (or a loss of a lot of hair during the pull test). The researcher then made dermatoscopic observations of the patient’s scalp, rating the patient’s trichological status on a scale of 0 to 3, with 3 indicating very good satisfaction with the patient’s trichological status (regarding the density of hair per unit area and for its diameter) and 0 poor satisfaction. The researcher asked the patient about his degree of satisfaction with his current condition, with 3 indicating perfect satisfaction and 0 indicating poor satisfaction.
Criteria for inclusion and exclusion
A total of 101 male volunteers, aged 18 to 79 years, with a diagnosis of androgenetic alopecia were selected.
Exclusion criteria for the purposes of the study represented the presence of psychiatric conditions in the volunteer, the presence of precancerous skin and systemic malignant conditions or severe systemic conditions such as diabetes or cirrhosis, and finally being on treatment for Androgenetic Alopecia with topical or systemic pharmacological formulations such as finasteride and minoxidil.
Features of RestaX 30+30 and RestaX Men's Lotion
Nutraceutical Restax 30+30 Contains:
Serenoa Repens Extract 320 mg:
Contains free fatty acids, with chain between C12 and C16, and beta Sitosterol as active ingredients, also reduces 5-alpha reductase activity by binding to the enzyme and inactivating it. Beta-sitosterol is chemically very similar to cholesterol and can therefore compete with it to bind to P450scc, which catalyzes its oxidation to pregnenolone, the precursor to testosterone, potentially slowing the conversion of Testosterone to DHT through this secondary mechanism as well.
Astaxanthin 2mg: plant-derived carotenoid extracted from the green alga Haematococcus pluvialis, is known for its high antioxidant and anti-inflammatory power.
Pinus pinaster dry bark extract 50 mg: Contains oligomeric proanthocyanidins, natural antioxidants. Proanthocyanidins are a class of polyphenols found in many varieties of botanical species, including pine bark, and possess antioxidant, hypoglycemic, and hypolipidemic properties. In addition, oligomeric proanthocyanidins help to strengthen the elasticity and functionality of the capillary bed, promoting better blood flow to tissues.
Whereas as for Restax Men’s Lotion 100mL :
Main solvent: 80% v/v water ethyl alcohol mixture, to best solubilize all product components
Dimethyl Sulfone 0.5%
It enhances the solubilization and release of all active ingredients, promoting their passage through the superficial keratin layer of the dermis.
Sphinganine 0.3%
It is a natural skin sphingolipid of fundamental importance for its biological functions. It acts physiologically on hair loss by rebalancing the hair cycle, nourishing the hair follicle and improving scalp health. Sphinganine balances the natural hair cycle and promotes the Anagen phase by slowing down the telogen phase through physiological 5-alpha reductase inhibition action.
Chasteberry 0.7%
Agnuside, contained in Agnocaste extract, is a natural progestin that acts by going to stimulate the skin-level activity of P450 aromatase. This stimulates the activity of adenylate cyclase, lengthening the ANAGEN phase. Agnocasto also regulates progesterone levels, influencing the Progesterone/Estrone ratio in favor of the former and inhibiting DHT synthesis.
Hops 0.35%
Hops extract contains phytoestrogens, which go on to physiologically increase follicular estrone levels, contributing to the activation and elongation of the ANAGEN phase. Specifically, Hops contains Hopein, the most potent phytoestrogen currently known, which exhibits enhanced ability to bind to estrogen receptors even comparing it to active ingredients with considerably higher concentrations (50-100 times), such as soy phytoestrogens. This is due to the higher bioavailability ofhopein compared to such substances.
Ribes nigrum 0.7%
Currant nigrum extract is a natural anti-inflammatory: it has the ability to block the synthesis of anti-inflammatory cytokines locally, which are often involved in the ultimate loss of the hair follicle.
Serenoa repens 0.7%
Serenoa repens extract is exclusively used in products for men, as it can cause serious side effects especially in pregnant women, being teratogenic to the fetus. In men, S.repens exerts an activity of physiological inhibition of the enzyme 5-alpha reductase, which is responsible for the reduction of Testosterone to DHT. This inhibitory activity is present for both isoforms of the enzyme, both the prostatic (type 2) and the one present in dermal cells (type 1). Consequently, lower concentrations of DHT are found at the follicular level after treatment with S.repens, and the activity of this hormone in stimulating hair loss and follicular atrophy is prevented.
Results of the study on male androgenetic alopecia
The study involved a total of 101 men ranging in age from 18 to 79 years, with a mean age of 35.38 years. At baseline conditions, 93 out of 101 patients had positive pull test results, 62 claimed to have trichodynia and 59 reported scalp itching. After 6 months of treatment, 44 patients still reported positive pull test results, 26 stated they had trichodynia and 19 stated they felt itchy scalp, with a percentage improvement (out of total patients) of 48.51% for pull test, 35.64% for trichodynia and finally 39.60% for itchy scalp. Regarding the mean ratings for the symptoms, before treatment the mean pull test result was 1.67, which is mean positive, the mean self-reported value of trichodynia was 0.96 and that of scalp itching was 0.82, both indicating mild discomfort. After 6 months of treatment, the mean value of pull test decreased to 0.49 that of trichodynia to 0.26 and itchy scalp to 0.19, with a % improvement of 71.00 for pull test, 73.20 for trichodynia and 77.10 for itchy scalp, with an overall marked reduction in symptoms.
Initially, the researcher stated an average hair diameter rating of 0.81 and an average hair number rating of 0.73 values indicating low satisfaction. At the end of the study, both values were reduced to 1.86 and 1.84 respectively, both indicating good satisfaction, with a % improvement of 60.21% for hair number and 56.38% regarding hair diameter.
Patients’ average satisfaction with their hair was 0.77 at the beginning of the study, indicating a suboptimal level of satisfaction; after 6 months, however, the average value stood at 2.21, indicating a good satisfaction, with an improvement of 65.02%.
Conclusions of the study
Male androgenetic alopecia is one of the most common conditions afflicting men, despite the fact that it is not yet recognized by the national health care system. However, this condition contributes to an issue of significant psychological impact and can affect the lives and relational ability of men who suffer from it.
Joint treatment with the nutraceutical Restax 30cps + 30 softgels and Restax Men’s Lotion, has been shown to be safe with no major side effects. It was also shown to be effective in reducing itching, trichodynia, and strengthening hair by reducing hair loss and improving hair diameter in patients with AGA. The men involved were found to be generally satisfied with the results obtained at the end of the study.
Bibliographical references
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