Double-Blind Study of PriaPlex® for Androgenetic Alopecia

Researchers recently completed a six-month, randomized, double-blind placebo controlled study designed to evaluate the efficacy of PriaPlex® for male pattern baldness (Androgenetic Alopecia, or AA). Researchers enrolled 40 patients (31 male, 9 female) diagnosed with male pattern baldness. At the end of six months, 32 patients had completed the full trial, and 8 had dropped out due to non-compliance issues (5 in the placebo group and 3 in the treatment group).

The study found that 9 of the 17 treatment subjects taking PriaPlex (52.9%) experienced significant hair growth, as measured by dermatoscopy and clinical photographs independently scored by dermatologists blind to the treatment conditions (Fig. 1). By comparison, only 2 of the 15 subjects (13%) receiving the placebo showed any signs of hair growth.

PriaPlexDermatoscopy2-1

The primary goal of this short, six-month study was to determine the efficacy of the formula in the intention-to-treat population — i.e., men and women with androgenetic alopecia. The significance of these results, after only six-months of treatment, become especially apparent when compared to similar measurements after treatment with Finasteride for 1 year (44%), 2 years (61%) and 5 years (48%) of use (Fig. 2).

PriaPlexGraph1

 One of the most interesting outcomes of the study was that each of the subjects receiving PriaPlex reported that their previous abnormal hair loss halted during the trial. In other words, PriaPlex completely stopped age-related hair loss in 100% of the cases.

Summary
By age 35, two-thirds of American men will have some degree of appreciable hair loss and by age 50 approximately 85% of men have significantly thinning hair. About 25% of men who suffer from male pattern baldness begin the painful process before they reach 21. Contrary to societal belief, most men who suffer from male pattern baldness are extremely unhappy with their situation and would do anything to change it. And hair loss isn’t an exclusively male issue — approximately 50% of all women over the age of 50 experience a similar condition referred to as female androgenetic alopecia.

In this short six-month trial, 100% of both male and female subjects taking PriaPlex for androgenetic alopecia experienced a total cessation of abnormal hair loss, and 53% experienced significant new hair growth. In addition to stopping the progression of age-related hair loss, PriaPlex was shown to support restoration of healthier, thicker hair in existing follicles.

Additional studies are underway to determine a fuller clinical picture of longer periods of continuous use of PriaPlex.

Clinical Protocols
Patients between 20 to 45 years old of both sexes with androgenetic alopecia were enrolled in the clinical trial. Exclusion criteria included hormone imbalances, metabolic diseases, cancers, unknown etiology of alopecia, infection, irritation or pain in the scalp. The pilot study, lasting 6 months, was a randomized, double-blind, placebo-controlled study involving 40 patients. 20 patients in the treatment group received 6 caplets of PriaPlex® daily (3 grams), and 20 patients received placebo. Male patients were diagnosed with alopecia based on the Norwood-Hamilton scale, and female patients were diagnosed with alopecia based on the Ludwig scale. Dermatoscopy and clinical macrophotographs were recorded monthly and independently scored by three dermatologists blind to treatment condition. Each patient was monitored with full lab clinical tests to measure TSH, DHEAs, testosterone, estrogen, kidney and liver function tests, and complete blood count. Clinical endpoints include Norwood-Hamilton and Ludwig scale, Fatigue Symptom Inventory, self-reporting hair loss, and color of hair. Adverse events were also monitored (none reported). Chi-square test was 0.01 <p <0.025 which showed statistical significant difference between the treatment and placebo group. Statistical data analysis includes use of student t-test and Wilcoxon rank-sum test, along with the Kolmogorov–Smirnov test (K–S test) for the testing for normality of the distribution.