E-Articles - Health and Fitness

The often heard phrase that ‘beauty is in the eye of the beholder’ can be applied to the subject of freckles. Indeed, while freckles are seen by some as a skin defect, others view t

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

hem as a rather cute feature that enhances the overall look of one’s face.

So what are freckles, what is their cause and how can they, if so desired, be prevented or removed?

The

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

Examples of combination products may in

appearance of freckles on one’s skin is the result of an uneven distribution of the pigment known as melanin. An unusually high concentration of melanin in a particular area results

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

in freckling. Also known as ephelides, freckles appear on portions of the skin that are exposed to sunlight (with existing freckles becoming more visible with increased exposure to

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

the sun’s rays), as the epidermis or outer layer of skin produces more melanin to protect the skin’s lower layers from the harmful effects of the sun’s rays.

Generally speaking, t

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

Combination pro

hose with fair skin (especially redheads) are more susceptible to freckles than those of darker pigmentation. The likelihood of developing freckles is largely dependent upon one’s g

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

enetic background.

The appearance of freckles should be taken as a warning that one may be predisposed to skin cancer. As such, those with freckles should be especially careful to

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

exposure to sunlight, and should be sure to apply a UVA and UVB sunscreen, containing avobenzone, zinc dioxide or titanium dioxide, to exposed areas when venturing out into the sun

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

for extended periods.

Other prudent steps to take to lessen the chances of freckling include wearing a hat with a wide brim, staying away from exposure to the sun during the late m

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

orning and early afternoon hours, and avoiding tanning beds.

If one already has freckles and wishes to reduce their visibility, there are a number of freckle fading creams on the m

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

rket, usually containing hydroquinone, which may be helpful. Another common approach to freckle reduction is the use of bleaching agents, which attempt to fade the areas of frecklin

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

Following aspects would a

g so their color matches that of the adjoining, non-freckled skin. This approach is often unsuccessful, as it may result in discoloring of the adjoining areas.

In recent years, a n

dd to the challenges in developing combination products:

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

umber of new treatments have presented themselves. These include freezing them with a form of liquid nitrogen, where there is a risk of scarring and there may be a significant recov

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

ery period before the skin heals. Other approaches include laser resurfacing (usually appropriate only for those whose skin has been significantly damaged) and chemical peels. The s

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

afer peels can be effective but require repeated applications, while the deeper peels while more effective require a substantial period of recovery. Another decent method is the use

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

of Retin-A, but again, a lengthy period of recovery can be expected. The other very common method in use is to mask the freckles with cosmetic products, including a mineral makeup.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Of course this does not rid one of the freckles, but merely covers them up.

For those seeking a more natural remedy, washing the face with sour milk allows the lactic acid in the

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

milk to gradually peel the skin (and the accompanying freckles). The daily application of lemon or parsley juice with one’s fingers can also cause the appearance of the freckles to

.

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

lighten and in some cases disappear altogether.

So there are a number of methods available for reducing and preventing freckling. But the most important advice one can give to thos

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

Companies that provide selfless information through particip

e who do freckle is to avoid frequent exposure to the sun, both to reduce freckling (if that is their desire) but more importantly, to minimize the chances of developing skin cancer

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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