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Discovering the derma segment
In spite of the treatments available, the dermatology segment
has left much to explore. Sushmi Dey does an update on the drugs, effects
and the R&D in the segment.
 Derma
has long being regarded a cosmetic segment. However, in opposition to the myth,
dermatology is a branch of medicine which deals with skin and its appendages
including hair, nails and sweat glands. Moreover, this also represents a significant
therapeutic area, a fact confirmed by increasing growth rates.
There are several diseases in dermatology segment which are related to skin,
hair and glands. However, the common ailments in dermatology are acne, atopic
dermatitis, warts, seborrhoeic dermatitis/cradle cap, nappy rash/ diaper dermatitis,
tinea/ringworm, allergic contact dermatitis /eczema, psoriasis, fungal infections,
urticaria, vitiligo, hyperpigmentation, lichen planus. Fungal infections, herpes,
vitiligo, seborrhea, seborrheic dermatitis, bacterial infections are also some
of the common diseases that give rise to various skin disorders.
And the medication….
One of the most popular skin grievance could be acne and so are the drugs to
cure it. "In modern allopathic medicine, acne is usually managed by a dermatologist
and it responds well within a few weeks' medication. The medication may include
local medication in form of lotion, creams, vitamin A derivatives or antibiotics
and other formulations. Oral medicines include antibiotics and vitamin A derivatives,"
says Dr Manish Joshi, Head-Medico Technical Department, Ozone Group. According
to Saxena, Isotretinoin is very effective in treatment of acne. "Isotretinoin
belongs to a family of medicines called retinoids, which are similar to vitamin
A. It alters DNA transcription, which decrease the size and output of sebaceous
glands," informs Dr Anuj Saxena, MD, Elder Health Care.
Similarly, for atopic dermatitis, allopathic medicines offer use of mosturisers
in the form of topical steroids and use of emollients to treat the disease.
"Steriod molecule is transported to the cell nucleus where it interacts
with DNA. This interaction causes to the cell to make proteins called lipo cortius
which then turn off the production of a chemical called arachidonic acid. Without
arachidonic acid many chemicals that cause inflammation in the skin and in the
rest of the body are not produced thus reducing inflammation. These powerful
inflammatory chemicals include prostaglandins, leukotriences and platelet activating
factors," asserts Saxena. Steriod free treatment is another way to treat
atopic dermatitis. This includes tacrolimus and pimecrolimus which are topical
immunomodulators which change some of the functions of the immune system that
specifically cause rash or atopic dermatitis.
Psoriasis, a challenge
As far as psoriasis is concerned, there is no definitive available medication.
"Though there are expanding ranges of effective allopathic treatments,
there is no definite cure for psoriasis. There are a large number compounds
which diminish or eliminate the rash. Cortisone based creams are effective and
easy to use but after prolonged use they become less effective and can cause
thinning of the skin. Tar based preparations also are effective and safe in
treating psoriasis," informs Joshi. Agrees Sudarshan Arora, President,
NCE Research, Lupin. "There are many therapeutic options available for
treatment of moderate to severe chronic stable plaque type of psoriasis. However,
existing treatments available are either incompletely effective or associated
with serious toxic effects. Thus, there is an urgent need for more efficacious
and safer drugs," says Arora.
Topical cortico steriods like Betamethasone, Beclomethasone, Mometasone, Clobetasol,
Hydrocor-tisone can be used to treat psoriasis. However, the mechanism of the
anti-inflammatory activity of the topical steroids, in general, is unclear.
"Corticosteroids are thought to act by the induction of phospholipase A2
inhibitory proteins, collectively called lipocortins. It is postulated that
these proteins control the biosynthesis of potent mediators of inflammation
such as prostaglandins and leukotrienes by inhibiting the release of their common
precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids
by phospholipase A2," avers Saxena.
Dermal infections
Fungal infections are treated by imidazoles like clotrimazole, econazole and
miconazole. These drugs inhibit a broad spectrum of fungi and act by causing
leakage of cellular contents which destroy fungi. For Herpes, which is caused
due to herpes virus and considered one of the most difficult viruses to control,
acyclovir is used.
Herpes is a double stranded DNA virus which infects humans only. The virus comes
into contact with broken skin or lining of mouth, or anus. It goes into the
nuclei of the cell and tries to reproduce itself or replicate. Even though the
cells are infected most people do not get symptoms. The virus replication process
destroys the cells it has invaded causing blisters/ulcers of skin. "Acyclovir
is a synthetic purine nucleoside analogue with in-vitro and in-vivo inhibitory
activity against herpes simplex virus types. In-vitro acyclovir triphosphate
stops replication of Herpes Viral DNA," explains Saxena.
Topical steroids are also used to treat vitiligo which is a pigmentation disorder
where monocyte cells that make pigment in the skin are destroyed. Reportedly,
almost four percent of Indian population is affected by this disease. Last year,
Wockhardt entered into an in-licensing deal with LSI of UK for Vitix, a patented
product for the management of Vitiligo. "Viticolor is safe for long-term
use and claims to improve quality of life index. It is already marketed in Europe,
North America, Africa and South East Asia," the company sources say.
Whereas, sulphur, salicylic acid, selenium and zinc are helpful in treatment
of Seborrhea which is a skin conditions that covers the skin with greasy, crusty
scales which are usually behind ears, under the arms, diaper rash and on the
face and neck. Antibiotics like pencillins (Amoxycillin), ciprofloxacin, azith-romycin
and clindamycin are used in the treatment of bacterial infections.
Side-effects
Though allopathic medicines are fast and effective, they are often accompanied
with side-effects like dry skin and lips, fragile skin, itching, peeling of
skin in palm/soles, thinning hair, dry red eyes, nose bleeds, bleeding gums,
muscle pain, increases sensitivity to sun and vision problem. Acyclovir which
is used in the treatment of herpes is sometimes accompanied with side-effects
like nausea, vomiting, diarrhea, fever, headache, dizziness, seizures, tremors,
hepatitis, elevated liver function and rash. Use of antibiotics can cause side-effects
like diarrhea, nausea, vomiting, abdominal pain, indigestion and allergic rashes.
An ayurvedic touch
The ancient science of ayurveda has some promising drugs
for the treatment of many dermatological ailments. "The holistic management
of health problems in ayurved comprises the three fold scientific approach towards
diseases through diet, lifestyle and medicine," explains Joshi. Ayurveda
offers external as well as internal medicines to treat many dermatological diseases.
It proposes a number of effective medicinal plants and other natural substances
like neem (Margosa) leaves, haldi (turmeric), kali mirch (black pepper) and
manjishtha (Indian madder). According to Joshi, a good number of classical and
proprietary ayurvedic formulations based on single or more medicinal plants
are beneficial in acne treatment. "Since, orally consumed medicines have
the advantage of reaching and releasing their actives in blood, their potential
to correct the abnormalities of all vitals become more effective," adds
Joshi.
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Acne: Acne is commonly known as pimples and
is a skin condition characterised by manifestation of whiteheads, blackheads
and inflamed red pimples or zits. Acne is caused by the effects of hormones
on sebaceous glands. When skin pores are blocked resulting in disorder
of skin's sebaceous glands, it takes the shape of a pimple or red inflamed
rashes that are sometimes also filled with pus. "Acne occurs when
sebum is not able to pass through the hair follicle. Skin cells lining
the follicles shed too fast and clump together, blocking up the follicles'
opening so sebum can not pass through. The mixture of sebum and cells
allows bacteria to grow. The blockage is called plug or comedone,"
explains Joshi. The comedone or plug can be closed with white top to form
whiteheads or open having black top which is called blackhead.
Atopic dermatitis: Dermatitis is a term used
to describe type of itchy rash that occurs in certain people with sensitive
or irritable skin. According to Saxena, atopic dermatitis is eczema that
is
itchy, recurrent, chronic and occurs on both sides symmetrically. With
atopic dermatitis, skin becomes inflamed with redness,
swelling, cracking, crusting and scaling. Atopic dermatitis may be accompanied
with asthma or allergic conditions. Eczema is common in infants and young
children and may disappear before adulthood. While the causes of atopic
dermatitis are not yet known, it is believed that it happens due to the
result of a built-in defect of the skin that tends to run in families.
This defect causes the skin to lose water and to become dry compared to
normal skin.
Warts: Warts is a viral infection of the
skin manifested as external skin outgrowth. Warts are caused by a virus
and are considered harmless. They have a rough surface on which tiny dark
specks may be seen. They may grow on any part of the body and their appearance
depends on their location.
Psoriasis: It is a chronic skin disease characterised
by scaling, redness and inflammation. "Scaling occurs when cells
in the outer layer of the skin reproduce faster than normal and pile on
the skin surface," tells Saxena. Psoriasis occurs when skin cells
quickly rise from their origin below the surface of the skin and pile
up on the surface before they have a chance to mature. According to Arora,
it is a comparatively easier skin disease to diagnose but very difficult
to treat causing frustration to patient and clinician alike.
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The homeo story
Homeopathic medicines provide yet another effective alternative in dermatology
segment. Homeopathy consists of more than 2,000 medicines treating various ailments
including skin problems. The use of these medicines depends on the symptoms
of the disease presented by the patients. Homeopathic medicines treat physical,
emotional and mental illnesses and regard them as intimately connected. Homeopathic
medicines like Kali bromatum, Silicea, Urtica urens, Rhus toxicodendron, Graphites,
Tellurium and Sulphur are helpful in treating various skin diseases.
Homeopathy is preferred in dermatological diseases as it emphasises on cure
of diseases rather than suppression. "Homeopathic medicines build general
immunity of the body and help the body to heal itself by stimulating the body's
own healing power to fight the disease," asserts Batra.
Homeopathic medicines are also considered safe and without any side-effects
due to their minute doses. "One of the largest studies of the efficacy
of homeopathy, carried out over a six year period at the Bristol Homeopathic
Hospital, UK, looked at the clinical outcomes of over 23,000 patients suffering
from skin allergy who were not helped by conventional medicines like steroids
that is generally used for most of the skin conditions. The study found that
82 percent with skin allergy showed improvement in their complaint following
homeopathic treatment," informs Batra.
What's up?
Lupin is amongst the companies which are ardently pursuing derma research. It
has in its kitty a novel anti-psoriasis compound called Desoris which acts by
enhancing IL-10. "Two exploratory studies were conducted to evaluate the
efficacy and safety of this herbal oral formulation for the treatment in patients
with chronic stable plaque type of psoriasis," informs Arora. In the first
study (open, non-comparative), out of 22 completed patients 11 patients showed
Psoriasis Area and Severity Index (PASI) score reduction by 100 percent and
10 patients showed more than 75 percent reduction in PASI score. In the second
study (double blind, randomised and parallel), treatment "LLL 3348"
was effective in reducing PASI score by 75 percent in eight out of 26 subjects.
"Further, there were no significant adverse effects of the drug observed
during clinical, ECG, and laboratory investigations evaluations when post-treatment
means were compared with pre-treatment means," avers Arora.
Lupin has recently also announced a collaboration project with Department of
Science and Technology (DST) for the clinical development of its psoriasis projects.
The collaboration will support the extended Phase I and Phase II trials of LL-4218,
a pure compound derived from an herbal source, for the treatment of chronic
stable plaque type of psoriasis. The project is expected to be completed in
two years.
Wockhardt has also signed an in-licensing agreement in April 2007 with Advanced
Biotechnologies of US to market a patent-protected product to treat scars. The
company is also planning to introduce a patented gel called Kelocote to treat
scars in the third quarter of 2007. Reportedly, Kelocote is a silicone gel for
scars arising from accidents, burns, surgery and acne as well as skin disorders
such as dermatitis and varicella. It is also useful in treating keloids, which
are fibrous growths formed over healed wounds. A press release from the company
informs that clinical trials on Indian patients are in progress.
The sheer number of complications in the segment added to increased requirements
have propelled the need for research. With few companies and fewer products
in the therapeutic area, it has all it takes to make it a promising segment,
the growth of which can be ensured by the novelty of the products that come
in.
sushmi.dey@expressindia.com
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