Personal care continues to get more personal with topical treatments designed to deliver substances to treat medical conditions. For example, Australian biotech company Acrux announced the results of an 8-month clinical trial conducted in the United States, demonstrating that its Testosterone MD-Lotion, when applied to the armpit of men with low testosterone, was able to effectively and safely restore testosterone levels to the normal range, with no adverse side effects.
According to a report by Medical News Today, the completion of the phase 2 trial, carried out across nine different centers in the United States, paves the way for the phase 3 trial--the final step needed prior to marketing approval from the US Food and Drug Administration (FDA) and other regulatory bodies in Europe and Australia.
"The delivery mechanism is a significant advance over conventional treatments such as gels, patches and injections, " said Richard Treagus, PhD, CEO of Acrux, in the report. "The fast-drying lotion is applied directly into the patient's armpit using a 'no-touch' applicator, in much the same way as a deodorant."
Market research in the United States amongst both patients and prescribers that use current testosterone replacement products, including gels and injections, showed a strong preference by the patients for daily application of the lotion over the existing products, reported the company. The new product will apply a precise dose of quick-drying lotion to the armpit once daily. The company has an international patent pending that covers the application to the armpit of a number of drugs, including testosterone, combined with a skin-penetration enhancer and a volatile liquid.
The leading gel currently is applied by hand daily as a 5-gram dose to the shoulders, upper arms and/or abdomen. It takes longer to dry and patients are advised to wear protective clothing after application to reduce the risk of transferring testosterone to others. In contrast, market research highlighted that the men considered the roll-on lotion would form part of a normal grooming routine and it could be discreetly applied, much like a deodorant.
Testosterone deficiency in men or hypogonadism is associated with a number of symptoms including lethargy, depression, reduced libido and decrease in muscle mass and bone density. It is estimated that over 20% of the US male population over 50 years of age suffer from testosterone deficiency. Approximately 10% of hypogonadal men currently receive testosterone replacement therapy, reports the company.