A recently revealed surprise addition to Phosphagenics’ pipeline is ketoconazole, with Phase 2 trials scheduled for the final quarter of this year but no further details supplied. Ketoconazole (Nizoral) is approved as an anti-fungal in human health but is also prescribed (legally) by vets as a fungal treatment for dogs, cats and horses. It is currently available in tablet form or for topical use as a cream, gel, foam, spray or shampoo. It has additional off-label uses.
Jev was excited by the possibility of a ketoconazole hair loss treatment. Although ketoconazole shampoo is only FDA-approved for the treatment of dandruff and seborrheic dermatitis of the scalp, several studies have demonstrated its effectiveness in treating male pattern baldness. It is unclear whether this is due to anti-inflammatory effect on fungal colonisation of the scalp or anti-androgenic effect, as ketoconazole appears to act on dihydrotestosterone, the hormone associated with follicular dysfunction. (1) (2) (3) If the latter reason for its efficacy is correct, TPM would likely improve results by enabling deeper penetration of the ketoconazole into the dermal papilla cells, which are the main targets for androgen in hair follicles. (4)
Survey results and statistics suggest the existence of strong market demand for effective hair loss treatments
• The number of hair loss sufferers, world-wide, seeking professional treatment more than doubled between 2004 and 2008 (5) . • 60% of surveyed hair loss sufferers said they would rather have more hair than money or friends. (5)
• Roughly a third (30%) of surveyed hair loss sufferers said they would give up sex if it meant they would get their hair back.(5)
• The hair loss industry is estimated to be valued at $3.5 billion in the U.S. and growing as the worldwide population ages(6)
• Ketoconazole is a key ingredient in DS Laboratories’ flagship hair regrowth product, Revita. The hundreds of reviews of the product on Amazon are mixed but company revenues nevertheless boomed by 78% in 2012.(7)
Additional off-label uses of ketoconazole (in oral form) include the treatment of priapism and female hirsutism (through anti-androgenic effect), which is interesting, but unlikely to bePOH’s intended market.(8)
The principal and approved indication of ketoconazole is as an anti-fungal treatment. It works by killing the fungus or yeast or preventing its growth.
Ketoconazole cream is used to treat: athlete's foot (tinea pedis; ringworm of the foot); ringworm of the body (tinea corporis); ringworm of the groin (tinea cruris; jock itch); seborrheic dermatitis; "sun fungus" (tinea versicolor; pityriasis versicolor) and yeast infection of the skin (cutaneous candidiasis). Ketoconazole foam or gel is used to treat seborrheic dermatitis (scaly areas on your skin or scalp) and ketoconazole 1% shampoo is used to treat dandruff.(9)
Use of oral ketoconazole to treat fungal conditions systemically comes with several serious health warnings, including hepatoxicity, so topical treatment, where possible, would seem preferable. Common side effects of topical ketoconazole include stinging, swelling, irritation, or redness of the treated skin and TPM would likely reduce these.
If tinea and jock itch are not sexy markets, the figures involved certainly are. Topical ketoconazole addresses a huge market. Tinea is thought to be the second most common skin complaint in the US, with as many as 25% of the population affected. The global market for human topical antifungals is estimated to be in excess of $2.5 billion, with the US accounting for approximately half of this.(10)
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