Innovative Hair Growth Stimulant Developed:

Cosmo Oil and Dr. Ito to Jointly Pursue Commercialization

Cosmo Oil Co., Ltd. (Head Office: Shibaura, Minato-ku, Tokyo; President: Yaichi Kimura), and Dr. Yoshiyasu Ito (Part-time lecturer at Department of Dermatology, National Defense Medical College, and Director of Daikanyama Derm-Plastic Clinic), announces that they have agreed to jointly pursue commercialization and business development of a hair growth stimulant containing 5-aminolevulinic acid (ALA) as an active ingredient. Details are as follows.

1. Development

A hair growth stimulant containing 5-aminolevulinic acid (ALA) and iron

2. Sample case

(Photo provided by Dr. Ito)

3. Process of development

Cosmo Oil has established the industrial production method of ALA, the principal component of the above stimulant, and owns many related patents. Recognizing its effectiveness, the company has also applied for the patent for the hair growth stimulant effects of ALA (Patent No. 36644809), but the related R&D has been suspended due to optical disorders that occur at the time of application at high dosages.

Dr. Ito is the developer of the photo dynamic therapy (PDT) for acne vulgaris (acne) using ALA. He found out that some of his patients with serious cases of ache reported less hair loss and growth of vellus hairs after PDT. Dr. Ito therefore focused on the potential of ALA as a hair growth stimulant, and discovered that, by combining ALA with iron, the effectiveness of the hair growth stimulant can be reinforced, and optical disorders due to high-concentration application can be avoided (Patent Application No. 2004-134709).

In commercializing the hair growth stimulant, the combining of technologies and patents of the two parties is required. Therefore, Cosmo Oil and Dr. Ito agreed to jointly pursue its commercialization and business development.

4. Future plans

Cosmo Oil plans to seek a wide range of possibilities for the business, including partnership with the developer; application to hair growth stimulant products (categorized as medicines) and hair restoration tonics (categorized as quasi-drugs, cosmetics, etc.); and expansion into the hair growth salon business.

<Reference> Review of the mechanism of action

ALA, which is administered as an ingredient in the hair growth stimulant, is selectively incorporated into the hair root (photo), and binds with compounded iron to be converted to cytochrome, heme, or heme enzyme. Among them, cytochrome synthesized in mitochondria that are often referred to as the “powerhouse of the cell” is an important compound to generate biological energy. Direct activation of hair root cells by administering ALA and iron is believed to provide innovative hair growth stimulation.

Conventional hair growth stimulants indirectly nourish hair root cells by removing scalp sebum or improving poor circulation. This agent is estimated to work more directly on hair root cells by directly injecting cytochrome into hair root cells. In fact, studies with mice confirmed ALA had more beneficial effects than other hair growth stimulants (see graph). In addition, the effects can be expected, regardless of gender, due to its mechanism of action.

Studies on the concomitant use of ALA and iron preparation

Cosmo Oil had discovered that ALA has more beneficial effects for hair growth than the positive control, croton oil, in the hair growth studies of ALA using mice, but discontinued its development due to optical disorders caused by application at high dosages.

Dr. Ito improved the effects by concomitant use of ALA and various irons in the mouse studies and solved the problems caused by excessive application. In addition, he performed tests at his clinic on volunteers from whom he obtained informed consent, and confirmed marked effects regardless of gender. Characteristics were reactions such as stopping of hair loss in the early stages of the trial use and growing of vellus hairs. Two-thirds of the subjects reported satisfaction after one month’s use (see graph).

ALA

ALA is a natural amino acid contained in all animals and plants. Cosmo Oil has previously discovered plant growth promoting effects in ALA, and succeeded in developing ALA-containing highly-functional fertilizer (Pentakeep V) in collaboration with Seiwa Co., Ltd., enjoying reputation mainly in the field of protected horticulture. Other known effects are improving anemia in baby pigs, promoting growth of livestock, and preventing disease damages in farmed fishes. Cosmo Oil has established a fermentation method to produce ALA, which used to be traded at a high price due to the difficulties in its chemical synthesis, and is promoting its application and development. Also, a manufacturing system in compliance with GMP, which is required for pharmaceutical usage, has been established and obtained approval from the US FDA (DMF).

Presentations on ALA are to be provided on May 19th at the International Bio Expo (Tokyo Big Sight) and on hair growth on June 12th at the 15th Conference of the Japan Photodynamic Association ALA Symposium (Iwata Grand Hotel).