Advanced Restoration Technologies, Inc., 9035 North 15th Place, Phoenix, AZ 85020, USA. docgmarcovici@aol.com.
Chronic inflammation of the hair follicle (HF) is considered a contributing factor in the pathogenesis of androgenetic alopecia (AGA). Previously, we clinically tested liposterolic extract of Serenoa repens (LSESr) and its glycoside, beta-sitosterol, in subjects with AGA and showed a highly positive response to treatment. In this study, we sought to determine whether blockade of inflammation using a composition containing LSESr as well as two anti-inflammatory agents (carnitine and thioctic acid) could alter the expression of molecular markers of inflammation in a well-established in vitro system. Using a well-validated assay representative of HF keratinocytes, specifically, stimulation of cultured human keratinocyte cells in vitro, we measured changes in gene expression of a spectrum of well-known inflammatory markers. Lipopolysaccharide (LPS) provided an inflammatory stimulus. In particular, we found that the composition effectively suppressed LPS-activated gene expression of chemokines, including CCL17, CXCL6 and LTB(4) associated with pathways involved in inflammation and apoptosis. Our data support the hypothesis that the test compound exhibits anti-inflammatory characteristics in a well-established in vitro assay representing HF keratinocyte gene expression. These findings suggest that 5-alpha reductase inhibitors combined with blockade of inflammatory processes could represent a novel two-pronged approach in the treatment of AGA with improved efficacy over current modalities. |
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Clinical Research and Development Network, Aurora, CO, USA.
BACKGROUND: Androgenetic alopecia (AGA) is characterized by the structural miniaturization of androgen-sensitive hair follicles in susceptible individuals and is anatomically defined within a given pattern of the scalp. Biochemically, one contributing factor of this disorder is the conversion of testosterone (T) to dihydrotestosterone (DHT) via the enzyme 5-alpha reductase (5AR). This metabolism is also key to the onset and progression of benign prostatic hyperplasia (BPH). Furthermore, AGA has also been shown to be responsive to drugs and agents used to treat BPH. Of note, certain botanical compounds have previously demonstrated efficacy against BPH. Here, we report the first example of a placebo-controlled, double-blind study undertaken in order to examine the benefit of these botanical substances in the treatment of AGA. OBJECTIVES: The goal of this study was to test botanically derived 5AR inhibitors, specifically the liposterolic extract of Serenoa repens (LSESr) and beta-sitosterol, in the treatment of AGA. Subjects: Included in this study were males between the ages of 23 and 64 years of age, in good health, with mild to moderate AGA. RESULTS: The results of this pilot study showed a highly positive response to treatment. The blinded investigative staff assessment report showed that 60% of (6/10) study subjects dosed with the active study formulation were rated as improved at the final visit. CONCLUSIONS: This study establishes the effectiveness of naturally occurring 5AR inhibitors against AGA for the first time, and justifies the expansion to larger trials. |
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Androgenic Alopecia, or pattern hair loss, is an autosomally mediated chronbiologic phenomenon, affecting over 40 million American men and 20 million American women. To date, there has been no safe, efficacious method of treating and/or reversing the progression of this disorder without the potential for negative side effect.
There have been numerous proposed treatments for baldness, but only a few have provided effective treatment over a wide range of patients, and none so far have been based on naturally occurring substances. AGA which describes pattern alopecia, is considered to be a genetically based disorder and is commonly characterized by thinning and loss of hair in affected individuals within a given pattern on the scalp. This disorder progresses by causing the affected hair follicles to become smaller and correspondingly
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finer. Eventually, the fine hairs may be lost and, thus, baldness results in the affected area. Hair has been classified as being of at least two distinct types, terminal and vellus.
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This study contemplates the benefit of a naturally derived composition for AGA in order to reduce or arrest the onset of hair loss associated with the disorder. The preferred formulation employs Beta-Sitosterol, saw palmetto berry extract, lecithin, inositol, phosphatidyl choline, niacin, and biotin in orally administered dosages. The method of treatment is administering a dosage of the stated ingredients. In one embodiment, the dosages may be combined in a single soft gel capsule. The preferred quantities of each is as shown in the following preferred dosage.
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According to the capsule formulation of Table 1, a gel capsule containing 200 mg of standardized saw palmetto extract is taken twice per day such as eachmorning and each evening.
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