E-Articles - Health and Fitness

It may seem strange to hear about a laser being used for hair regrowth, but this type of treatment has been around for some time and was discovered accidentally by a scientist testing the effects laser radiation on mice. It

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

was in 1967 soon after the first working laser was invented that Dr Endre Mester at Semmelweis, university in Hungary was carrying our research to see if laser radiation cased cancer in mice. No cancers were found, but wha

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

surprised him was that hair grew back much more quickly on a shaved test area of the mice than on the mice in an untreated group. This effect called low level laser therapy (LLLT) also known as laser biostimulation, photob

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

omodulation and cold laser therapy is now used for the treatment of hair regrowth.

Possibly due to the then high cost of laser technology, very little research was carried out over the two decades after the first experimen

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

s were conducted. During the 1980s LLLT started becoming available as an expensive treatment through a number of exclusive hair clinics. The lasers used were large complicated fixed devices where patients had to sit under a

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

hood similar to a salon hair dryer. Treatments were performed as frequently as 2-3 times per week, this was often inconvenient for individuals who might have to travel many miles to the nearest clinic or salon. However the

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

esults achieved were very good and soon, many salons all over the Europe, Asia and later in the US began offering treatments.

This laser hair regrowth treatment has now been backed up as an effective hair loss treatment by

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

many scientific studies. In 1982 Trelles, M., and Mayayo, E, published “The Growth of Hair Under Laser Influence of the HE-NE Beam”. In this study, patients with alopecia areata responded with positive results after only 6

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

o 8 twice weekly treatments. Later studies in the 1990’s tested lasers working at different wavelengths and pulsing the laser to find the most effective laser configuration for treating hair loss. Most therapeutic lasers no

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

operate at a wavelength in the range 600-1000nm where the wavelength is related to how far the light penetrates the scalp. The best wavelength to use is still argued over but it should be sufficient to penetrate at least 5

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

6mm depth to target the hair bulbs. Many current LLLT devices operate using visible red light at a wavelength of 660nm which can penetrate down to a depth of about 8-10mm. Higher wavelength lasers at 800-900nm are also used

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

these can penetrate to a depth of about 30-40mm but these are mainly used for treating joints and muscle related problems.

More recent LLLT laser hair regrowth studies have started to reveal the reasons why and how laser

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ight therapy helps stimulate hair regrowth. These studies have shown that laser light increases the levels of a chemical compound called adenosine triphosphate (ATP) which is known to stimulate living cells including the ha

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

r follicles. LLLT also has the effect of increasing the circulation of blood to the hair root which delivers the nutrients to cells that make up the hair follicle. The increased blood flow is also thought to help flush away

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

the damaging waste products that may affect the hair growth cycle. This helps to improve the scalp environment to help stop thinning hair and promote new hair growth.

Over the last few years laser technology has advanced t

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

a stage where a laser devices can now be manufactured to a size smaller than your small finger nail and at very low cost. In 2000 a company developed and patented the first miniature LLLT laser hair regrowth device using t

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

e new laser technology. This made possible for the first time an effective LLLT hair loss treatment that was cheap and small enough be used in your own home without having to go to an expensive hair clinic. The new device c

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

mes in the form of a hair comb/brush that needs only be used for 10-15 minutes three times per week. The manufacturers claim that while users experience will vary, 45% of users will see positive results after 8 weeks of tre

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

tment with another 45% seeing benefits from 10-16 weeks onward.

In February 2007 the U.S. Food & Drug Administration (FDA) cleared the laser comb device for use in the treatment of hair regrowth. The laser comb is now one

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

f only three treatments cleared by the FDA for use in hair regrowth the others being Finasteride and Minoxidil. The laser hair regrowth device now brings new hope to the many men and women suffering from premature hair loss

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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