Skin Deep - A Dermatology Blog

Requirements for research in cosmetic dermatology

noreply@blogger.com (Bell) — Sat, 21 Nov 2009 07:16:00 +0000

Research in Cosmetic Dermatology: Reconciling medicine with business: (Part II / IV)

The complete article is available as a printable pdf file from the Munich Personal RePEc Archive (MPRA) below:

http://mpra.ub.uni-muenchen.de/16515/

The term research has a different meaning in cosmeceutical industry. Some big organisations use the term for product or service improvement. Optimization of existing technology for specific needs (not necessarily different indications) is a common practice in cosmeceutical industry. Each organization conducts its on research for optimizing the technology. As this is often conducted without a proper understanding of clinical research paradigms, certain errors of judgment are frequently encountered.

THE NEED TO COMPARE
It is always worthwhile to compare new technologies to already available ones in terms of efficacy and adverse effects. For example several depigmenting agents are known with varying levels of efficacy. When a new and more expensive product combination is introduced, it is important to compare it with individual components used alone to justify the cost of the combination. However the decision of whether to adopt a new technology should not be based entirely on the results of comparison. But the comparison will give clear indications about the likely success and the potential problems during introduction and has substantial marketing value.

THE NEED TO RANDOMIZE
Randomization is given due importance in pharma trials. But many cosmeceutical researchers rely on a 'study group cohort 'rather than random sample. The active ingredient, vehicle or even contaminants in a cosmeceutical can cause an allergic or irritant reaction in a small percentage of users.(8) Manufacturers try to assess the risk during the trial period. If the trials are conducted on the same group always, the group undergoes a natural selection process as those who develop a reaction are unlikely to report for further trials. The results on this 'thick skinned' cohort cannot be reliably extended to the general population.

THE NEED FOR BLINDING
Blinding is another important concept often ignored in cosmeceutical research. Sometimes blinding can be difficult or impossible to implement especially for those trials involving machines. Hence most of the studies are plagued by researcher as well as subject bias. This bias gets confounded several times when the researchers also become part of the study group, a practice common in cosmeceutical research. Individual service providers often comment that they have tried the product or service on themselves and found it to be safe and effective. Having an independent blinded observer who does majority of assessment can significantly reduce the bias. But bias cannot be completely removed from study design in cosmeseutical research and should be kept in mind during final evaluation.

THE NEED FOR OBJECTIVE ASSESSMENT
The assessment is often subjective in cosmeceutical research. The unavoidable biases along with subjective assessment methods make the studies less credible. It is important to make full use of new, objective assessment techniques involving computer assisted image analysis and optical spectroscopy. Computer assisted image analysis is the computational extraction of meaningful information from digital images by pattern recognition and digital geometry.(9) Optical spectroscopy involves study of scattering and reflectance pattern of the skin for an objective assessment of appearance. (10)

THE NEED TO USE MOLECULAR AND CELL BIOLOGY TECHNIQUES
The chance of success for a cosmeceutical is likely to be higher if it has a strong basis in molecular and cell biology. Ingredients developed on the basis of its effect on well characterized molecular targets are more likely to be successful. The new generation growth factors and aquaporin modulators are typical examples.(11) The recent developments like in vitro human skin helps in assessing the efficacy and adverse effects of cosmeceuticals in a more objective and safe way.(12)

THE NEED TO CONSIDER SKIN AND LIFE-STYLE VARIATIONS
The importance of skin type in the choice of cosmeceuticals is well known. Certain lasers are considered not safe on darker skin as the chances of developing adverse effects are more.(13) The environment and life style can also have a significant effect on skin biophysical characteristics. Hence it is important to account for these confounding factors in study designs especially for those cosmeceuticals promoted as suitable for all skin types.

THE NEED FOR LONG TERM FOLLOW-UP
Since cosmeceuticals are not strictly regulated, products are introduced based on studies conducted for a few days or weeks or at most a few months. Since a watchdog like FDA is not present, certain technologies are introduced into the market without enough studies to back the safety claims of manufacturers. Often the user is not even aware of this fact. Permanent dermal fillers are a typical example.(14) It is known that foreign bodies can elicit a tissue reaction after prolonged periods of exposure. Hence short term safety of dermal fillers does not guarantee its long term safety after several injections. Long term follow-up studies are lacking for many dermal filler materials. The same applies to other techniques like laser as well.

Research in Cosmetic Dermatology: Reconciling medicine with business: (Part I / IV)

noreply@blogger.com (Bell) — Fri, 14 Aug 2009 12:24:00 +0000

The complete article is available as a printable pdf file from the Munich Personal RePEc Archive (MPRA) below:
http://mpra.ub.uni-muenchen.de/16515/

Cosmetic dermatology is a unique specialty where clinical medicine has a legitimate but often detested relationship with business. There are people lined up on either side of the hazy line between medicine and business, each group trying to understand the other. True clinical dermatologists consider cosmetic dermatology an imprecise and vague specialty.(1)

A cosmeceutical, is conventionally defined as a cosmetic product claimed to have drug-like properties.(2) The term cosmeceutical is a portmanteau of the words "cosmetic" and "pharmaceutical” and is not recognized by Food and Drug Administration (FDA). A cosmeceutical is not subject to FDA review and approval processes.(3) Medical devices used in cosmetic dermatology range from cautery machines to lasers. Injectable enhancement products like Botox®(4) and dermal fillers are also popular. The Division of General, Restorative and Neurological Devices (DGRND) within FDA regulates most of the medical devices and injectable dermal fillers used by dermatologists.(5) In this article the term “cosmeceutical” is used to represent cosmetic products, injectable products and medical devices (like microdermabrasion and laser machines) used in cosmetic dermatology.

The pharmaceutical research paradigms of target identification, screening, lead optimization and clinical trials from phase I to IV do not directly apply in cosmeceutical research.(6) In pharma the industry decides what is good for the patient where as in cosmetic dermatology the patient decides what is good for him/her. Hence it is not imperative that a significant placebo effect be identified and accounted for even if it arises from a dominant bias. A typical example is Laser Hair Reduction. It is very difficult to conclusively prove that it is more effective than any other hair removal method to justify its cost. But it is a billion dollar industry and is considered a ‘successful technology’ in cosmeceutical arena.(7)

This article is an attempt to reconcile research in cosmetic dermatology with business and market research. First we discuss the basic requirements for clinical research in cosmetic dermatology. Then we move on to the uncertainties faced by decision makers and the mathematical models which may be of help in solving them. Finally we briefly discuss the market research techniques used in cosmeceutical industry.

To be continued..

Notalgia Paresthetica

noreply@blogger.com (Bell) — Wed, 10 Sep 2008 03:07:00 +0000

This patient presented to me with this pigmented itchy patch over the right infra scapular region. He had a neurological disorder with paresthesia extending to right finger tips. There is a report of successful treatment of this condition with Botulinum Toxin Type A. [Arch Dermatol. 2007; 143(8):980-982.]

Pitted keratolysis

noreply@blogger.com (Bell) — Fri, 20 Jun 2008 20:32:00 +0000

Pitted keratolysis is caused by a cutaneous infection with Corynebacterium and Actinomyces. It is often associated with hyperhidrosis. It is common in this part of the world because of occlusive footwear. Twice daily application of erythromycin or clindamycin is effective.

Speckled lentiginous nevus

noreply@blogger.com (Bell) — Fri, 09 May 2008 07:34:00 +0000

Speckled lentiginous nevus is a patch of hyperpigmentation representing a localized defect in neural crest melanoblasts. Several black or brown macules are seen within a patch of brown hyperpigmentation. Some consider this a variant of Congenital melanocytic naevus.

DermaMan: A dermatology calculator for PDAs

noreply@blogger.com (Bell) — Sun, 06 Jan 2008 18:44:00 +0000

I have recently made a simple application to bring basic dermatology related calculations to hand held devices in Java. It includes modules for frequently used dermatological calculations like PASI, MASI, SCORAD and for PUVA and Botox (R) related calculations.

DermaMan is a freeware which can be downloaded from http://www.gulfdoctor.net/derm/dermaman.htm if you are accessing from a PC and http://www.gulfdoctor.net/mobile/derm.htm if you are accessing from your hand held device for over-the-air installation. All modules are packaged as a single JAR file. Specific instructions for installation depend on your device and are usually available from the manufacturer’s user-guide. General instructions are available from the web pages mentioned above.

A more detailed description of the software is in print in the ‘Resident’s corner’ section of IJDVL, March-2008 issue. Please read the disclaimer before you download the software. Use this thread for support, bug report and feature requests.

Fixed Drug Eruptions (FDE)

noreply@blogger.com (Bell) — Sun, 02 Dec 2007 13:24:00 +0000

Hands, feet, and genitalia are the most common locations for Fixed Drug Eruptions (FDE) and lesions recur in the same area when the offending drug is given.

Hansens Disease (Leprosy)

noreply@blogger.com (Bell) — Thu, 13 Sep 2007 17:15:00 +0000

First Hansen’s I have seen after coming here. The treatment was hindered by the non availability of Dapsone and clofazamine. With the emergence of latest bactericidal drugs it is not much of a problem any more.

Sclerotic patch

noreply@blogger.com (Bell) — Thu, 02 Aug 2007 18:19:00 +0000

This 35 year old Asian male patient presented with this unilateral hyperpigmented sclerotic patch over the face for 20 years. What is your diagnosis?

Periorificial crusting and acral desquamation

noreply@blogger.com (Dr. Shahbaz A.Janjua) — Sat, 02 Jun 2007 04:56:00 +0000

This poorly nourished 2-year-old girl developed asymptomatic erythema and crusting of the periorificial areas of the face over last one month. Desquamation of the distal phalanges of the fingers and the toes was also noted. Please take a look at the images and share your comments regarding the differential diagnosis.

noreply@blogger.com (Bell) — Wed, 16 May 2007 17:48:00 +0000

Pityriasis rosea is a skin disease characterized by sharply defined pruritic red patches covered by fine scales mostly affecting young adults. Typical lesions usually affect the trunk in a Christmas-tree pattern and it usually resolves spontaneously after 6 weeks. This patient reported with classic presentation of pityriasis rosea except for the unusual associated palmar lesions. A VDRL test was suggested but the patient refused.

noreply@blogger.com (Bell) — Fri, 16 Mar 2007 18:40:00 +0000

This is a query I recently received.

"The spots (they all have a hair coming out of the middle) pretty much stay there permanently. They have been around months but got real bad a month ago. Putting isotretinoin cream on made it much worse giving massive whiteheads and cysts. After stopping it reverted to how it is now. The area is pretty dry, a little scaly, itchy and quite red. It started in the left corner of my mouth (where I once had a massive cyst) and little spots started popping up and were especially visible if you pulled the skin. There are now plenty all over my chin, particularly in the crevice in the middle. Sometimes there are whiteheads but these are more like scabs. I get quite a lot of big spots on the corners of my mouth (esp. the left). I saw a derm a month ago. He said it was acne and put me on oral isotretinoin (my 4th dose). Its done nothing so far. I have read about perioral dermatitis and have started using a non SLS toothpaste but no effect so far. I also have no spots above the lip. The photographed regions are the only affected. My derm prescribed topical steroid, I read these can make things worse. I was on Azathioprine (autoimmune hepatitis) for 2 years till a month ago. I havent had oral steroids for AIH in 9 months. I did get an outbreak of folliculitis in the pubic region about 5 months ago. This was quickly resolved with antibiotics. Could this be a similar thing although it looks and feels different? "

A recurrent vesicular eruption

noreply@blogger.com (Dr. Shahbaz A.Janjua) — Fri, 26 Jan 2007 12:34:00 +0000

This 4-year-old boy had a recurrent vesicular eruption on the sun exposed areas for three years. The eruption would heal with varioliform scarring. The boy's father and one of the siblings had similar problem since early childhood. What would be the ddx?

Hyper pigmentation in neonate

noreply@blogger.com (kiran nabar) — Wed, 13 Dec 2006 17:59:00 +0000

This 17 days old baby girl developed such mottled hyper pigmentation on face and rest of the body since last 2 days. There is no h/o prior rash. There is h/o fever on day 5 after birth for which baby was admitted by pediatrician and she received 5 days course of ampicillin, Inj.Gentamycin and Inj.Ceftrioxone. It was normal delivery but at 36th week of gestation. Except for pigmentation she was otherwise normal.

Acute generalised exanthematous pustulosis (AGEP)

noreply@blogger.com (Bell) — Sat, 02 Dec 2006 14:56:00 +0000

This patient presented to me with sudden onset of widespread non follicular pustules over his body. He did not give personal or family history of psoriasis. My diagnosis was Acute generalised exanthematous pustulosis (AGEP). AGEP is a condition characterised by sudden onset of non-follicular aseptic pustules all over the body. Among drug-induced skin eruptions, AGEP is remarkable by its short time to onset after the administration of the suspected drug (less than 24 hours) and the great predominance (80%) of antibiotics as causative agents. Though it is generally easy to elicit a drug history in AGEP, I did not succeed. After 2 days patient called me and told that he remembered taking an Ayurvedic concoction called arishtam on the previous day of erruption. A literature search showed that, after drug reactions, the most common causes of AGEP are acute infections with enteroviruses, and hypersensitivity to mercury. Without taking sides, let me refer you to this article here:
http://faculty.washington.edu/chudler/ayur.html

Progressive Palmo Plantar Keratoderma of Greither

noreply@blogger.com (Bell) — Tue, 21 Nov 2006 08:10:00 +0000

Today an old patient of mine came with his brother who had severe palmo plantar keratoderma since childhood which worsened after coming to Gulf. The most striking feature was the transgrediens. They said several members of their family have this problem. With my broken Hindi, I managed to elicit sufficient history to draw a crude pedigree chart. Based on the livid transgrediens, I came to a diagnosis of Progressive PPK (Greither disease or PPK of Sybert). I started him on 50% urea and 0.05% tretinoin. Before leaving my old patient (A in the chart) asked me about the chances of this condition developing in his children. What is your answer?

Polymorphous Light Eruption (PLE / PMLE)

noreply@blogger.com (Bell) — Thu, 16 Nov 2006 06:24:00 +0000

Differentiation of PLE on pigmented skin from Actinic LP can be tricky without a biopsy as the second condition is also fairly common in India and Gulf. On fair skin PLE is described as ‘pink or red raised spots’ [ http://dermnetnz.org/reactions/pmle.html ] but the pink hue is never appreciable on pigmented skin. PLE is generally pruritic and involves photo exposed areas, often sparing the face as in the above case. Actinic LP is non-pruritic and commonly involves the face as the case posted below (http://www.gulfdoctor.net/blog/2006/01/diagnosis.html ).

Follicular Lesions

noreply@blogger.com (Bell) — Mon, 06 Nov 2006 13:39:00 +0000

A 36 year old male patient with these unilateral follicular lesions of 4 months duration over the shin. What is your diagnosis?

Ichthyosis Linearis Circumflexa (ILC) of Netherton Syndrome (NS)

noreply@blogger.com (Bell) — Mon, 30 Oct 2006 18:49:00 +0000

This 4 year old female patient presented with history of congenital erythroderma (without Colloidal membrane), which was evident during the first weeks of life and severe pruritic dermatosis. History of hair loss was given though it was not severe when she presented to me. Though lesions where predominantly ichthyosiform with a predilection for extremities, she also had eczematous peri-oral lesions characteristic of NS. However flexural lichenification was not prominent. ILC is a characteristic serpiginous migratory annular/polycyclic rash with double-edged scale.

More on the genomic and molecular aspects of this disease in my Applied - Bimatics (http://gulfdoctor.net/bioblog/2006/02/plasmin.html) Blog.

Lupus Vulgaris

noreply@blogger.com (kiran nabar) — Wed, 25 Oct 2006 18:14:00 +0000

This 18 yr girl was brought for asymptomatic lesion on left elbow since last 3 months.It was a small papule to begin with, then grew slowly but steadily to attain present size. There is spontaneous healing with atrophy in the upper half .Secondary infection at the lower border is since last 5 days,Another small lesion inferior to the main lesion is post traumatic ecthyma (since 10 days.)There is no h/o injury prior to the main lesion.She also developed slightly tender matted epitrochlear lymphadenopathy 1month after the onset of the lesion.She had taken Anti tubercular treatment for 9 months(1 yr back )for pulmonary Kochs.Her father also had pulmonary Kochs.

Nodulocystic Acne

noreply@blogger.com (Bell) — Mon, 23 Oct 2006 15:41:00 +0000

Nodulocystic acne is a severe form of acne affecting the face, chest and back characterised by multiple inflamed and uninflamed nodules and frequently, scars. It is more common in males. Acne conglobata is an uncommon form of nodulocystic acne in which there are interconnecting abscesses and sinuses. Nodulocystic acne may very rarely be a manifestation of a genetic disorder, PAPA syndrome (Pyogenic Arthritis, Pyoderma gangrenosum and Acne. Autosomal Dominant). This patient was treated with isotretinoin, but lesions recurred after few months of stoping therapy.

Forehead Lesions

noreply@blogger.com (Bell) — Sun, 01 Oct 2006 16:18:00 +0000

A 30 year old male patient with these hyperpigmented hyperkeratotic lesions over the forehead since 2 years. What is your diagnosis?

Geographic tongue

noreply@blogger.com (Bell) — Thu, 28 Sep 2006 15:16:00 +0000

Geographic tongue is a relatively common benign condition which may cause significant psychological morbidity. Though often asymptomatic, some may complain of burning sensation or irritation with hot or spicy food as in this patient. He also had a median fissure which is a frequent association. He also gave history of recurrent oral ulcers.

Hyperpigmented Patches.

noreply@blogger.com (Bell) — Mon, 04 Sep 2006 08:44:00 +0000

This 25 year old male welder presented to me with well demarcated asymptomatic hyperpigmented spots over the face, neck, back and extremities since 4-6 months. What is your diagnosis?

Chronic Folliculitis of Legs (CFL / DCPA)

noreply@blogger.com (Bell) — Thu, 24 Aug 2006 15:11:00 +0000

Chronic folliculitis of legs, though not uncommon in India, is not frequently seen in the same expatriate population in Gulf. This is a case I saw few days back. However he complained that lesions appeared only when he is in gulf and disappeared completely while in India! PUVA and Co-Trimoxazole have found to be useful in reducing recurrence. Co-Trimoxazole retains high sensitivity in this region probably because of decreased use.