Multicenter randomized clinical trial of a nutraceutical and a lotion in male patients with androgenetic alopecia

Tricoblog

Multicenter randomized clinical trial of a nutraceutical and a lotion in male patients with androgenetic alopecia

Paolo Gigli, Antonella Parlangeli, Cristian Giani, Gino Favero, Francesco Rinaldi, Maria Grazia Cusmai, Mauro Mazzeo, Elda De Leo, Lucia Villa, Donata Franchini, Antonia Liotino, Emanuela Barberio and Andrea Marliani.

1. Introduction

Androgenetic alopecia is a common problem in men, occurring on average between the ages of 35 and 45 years. 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 joining with the receding hairline area. Such retreat is due to the physiological action of testosterone, and conjunction with apical (vertex) hair loss often results in a situation of “crown” baldness, in which 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 Male Androgenetic Alopecia Androgenetica, a multifactorial approach is necessary: first, it is necessary to counteract the action exerted by DHT at the follicular level, so as to prevent follicle fibrosis and its atrophy; second, it is necessary to act by going to reduce the inflammatory component always present in this pathology. This can be achieved either with low-dose pharmaceutical actives for topical use, usually containing cortisone or other corticosteroids, or with the use of specific, targeted nutraceuticals taken systemically. In addition to these products taken by os, topical lotions containing anti-inflammatory agents of natural origin can 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.

2. Study Target

To evaluate the efficacy of a nutraceutical (Restax® Flogo 30cps) administered for a period of 3 months, (Restax® 30softgel+30cps) administered for an additional 3 months, and a hair lotion (Trivis AGA Men’s Lotion 100mL) administered for a period of 6 months in the treatment of patients presenting with symptoms of mild to moderate male androgenetic alopecia. Assessing the reduction of hair loss, their possible increase in density and diameter, the evaluation will be done by means of a form filled out by the doctor at time 0 and after 6 months of treatment. In addition, as a secondary end-point, the study aims to assess the tolerability of these products for use in chronic therapies.

3. Materials anf Method

Each patient was asked during the first 3 months to take 1 capsule of Restax Flogo 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, to damp or dry hair not necessarily washed before each application. For the next 3 months until study completion, the Restax Flogo supplement was replaced with Restax 30+30, of which the patient would take one capsule and one soft gel daily during dinner.

The researcher after examination and history of the patient then filled out the questionnaire at T0 and T6, assessing clinical symptoms such as pull test result, presence of trichodynia, itching, and yellow dots around the follicles, using a scale of 0 to 5 where 0 indicated the absence of the symptom (and for the pull test 0 indicated negative result) and 5 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 overall status on a scale of 0 to 5, with 5 indicating very good satisfaction with the patient’s trichological status (regarding hair density per unit area and hair diameter) and 0 poor satisfaction. The researcher then rated the patient’s situation against the Norwood-Hamilton scale of baldness, which has reference values from 1 to 7, with 1 indicating a normal situation and 7 indicating advanced androgenetic alopecia

3.1 Inclusion and Exclusion Criteria. A total of 121 male volunteers aged 18 to 79 years who were diagnosed with androgenetic alopecia were selected.. Exclusion criteria for the purpose of the study represented the presence of psychiatric conditions in the volunteer, the presence of precancerous cutaneous and systemic malignant conditions or severe systemic conditions such as diabetes or cirrhosis, and finally, being under treatment for Androgenetic Alopecia with topical or systemic pharmacological formulations, such as finasteride and minoxidil.

3.2 Characteristics of the products tested Content of Restax nutraceutical:

Serenoa repens extract 320 mg: Containing free fatty acids with chain between C12 and C16 and Sitosterol beta as active ingredients, both reduce 5-alpha-reductase activity by binding to the enzyme and inactivating it.
Beta-sitosterol is also chemically very similar to cholesterol and can therefore compete with it to bind to P450scc, which catalyzes its oxidation to pregnenolone, the precursor of 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: Containing oligomeric proanthocyanidins, natural antioxidants. Proanthocyanidins help strengthen the elasticity and functionality of the capillary bed by promoting better blood flow to tissues.

Contents of the nutraceutical Restax Flogo 30cps:

Epilobium 350mg, Phytosterols 200mg, Proanthocyanidins 27 mg, Astaxanthin 1.3mg.
The difference from Restax is the higher content in β-sitosterol titer (140mg per cps).
Epilobium extract exerts specific anti-inflammatory action by reducing COX-2 via ellagitannins.

Contents of Trivis Men’s Lotion 100ml: Contains Dimethyl Sulfone, D-Xylose, Melatonin, Sphinganine, Pumpkin Seed Extract, 18 β-glycyrrhetinic Acid, Caffeine and Sorbitol.

Dimethyl Sulfone: enhances the release of active ingredients..
D-Xylose: humectant and heat-protective agent..
Melatonin: reduces apoptosis and stimulates growth via estrogen receptors.
Sphinganine: promotes Anagen phase and rebalances the hair cycle by inhibiting 5 alpha reductase.
Pumpkin Seed Extract: anti-androgenic and sebum-regulating action..
18 β-glycyrrhetinic acid: natural steroid with potent anti-inflammatory effect.
Caffeine: reduces the effects of DHT locally..
Sorbitol: hair cell nutrient with moisturizing action..

4. Results

The study involved 121 men (mean age 38.33 years). At the start of the study, 115 patients had a positive pull test, 112 trichodynia, 115 itching and 119 yellow dots. After 6 months of treatment, patients with positive pull-test decreased to 35, those with trichodynia to 17, with itching to 22 and with yellow dots to 25. Average overall physician rating increased from 2.802 to 3.512 (+25.34%). The mean value of the Norwood-Hamilton scale improved from 3.479 to 1.933 (-44.44%). No patients complained of any side effects.

5. Conclusions

Joint treatment with Restax Flogo and Trivis AGA Men’s Lotion (first 3 months), followed by Restax 30+30 and lotion (next 3 months), has been shown to be effective in reducing itching, trichodynia, and perifollicular inflammation, as well as strengthening hair by reducing hair loss. Patients were satisfied with the results obtained ..