GLG News by Dermatolopathologists (US)
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September 28, 2007Relieva results in recent clinical trial for eczema
Analysis of: Relieva Exceeds Expectations In Recent Clinical Trial For Eczema (Atopic Dermatitis) | www.medicalnewstoday.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
The recent results for a trial of Relieva in atopic dermatitis or eczema, a cream containing a homeopathic compound, were positive by a report from the company. The study sample was small, and the trial was open label. Generally these trials have a larger number of patients, and are blinded. Also it...
September 10, 2007FDA issues warning to Melanocorp
Analysis of: FDA Issues Warning Letter To Melanocorp, Inc. For Illegal Sale Of Melanotan II -Agency Warns Consumers About Using And Purchasing Unapproved Product | www.medicalnewstoday.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
The FDA warning to Melanocorp regarding their product Melanotan was justified. These warnings are far too few and infrequent, and numerous companies make claims without studies or substantiation. The agency is overwhelmed with NDA's, and has difficulty handling the work that currently exists....
July 12, 2007Vaniqa's effect on laser hair removal
Analysis of: Laser Hair Removal Enhanced With Eflornithine Cream | www.medscape.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
I do not believe that Vaniqa will have a negative effect on Laser hair removal as its efficacy is only temporary. In fact we use it as an adjunct for patients with resistant areas. Its use may actually enhance the use of Laser devices as they offer permanence. The products use may be increasing as more...
June 18, 2007Dermlex Launch
Analysis of: Advitech to finally launch Dermylex in US | www.nutraingredients-usa.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
Advitech's launch of Dermylex will not have much of an impact on the psoriasis market. This is due to the fact that the product has minimal studies to back it up, and the company will rely on testimonials. This is not an effective way of marketing to physicians, and is difficult with patients....
June 4, 2007Melafind Phase three implications
Analysis of: Digital Diagnosis: New Tool for Detecting Skin Cancer | www.ehponline.org
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
If Melafinds phase three study results are positive then physicians will in general be receptive. The only issues are: 1. Ease of use/time to scan 2. Ability for non physician personnel to be trained to use the technology. 3. cost 4. Insurance reimbursement The technology may have more use at larger...
June 4, 2007Modus product-?efficacy
Analysis of: No Hydroquinone, Means No Worries for Modus. Dr.’s Applaud Europe’s New Import To Fight Signs of Aging | www.rushprnews.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
The new Modus product "without hydroquinone" cannot be fully evaluated on the basis of the currently available information. Decisions based on the opinions of a "Beauty Editor", and 6 years worth of studies with only 4 patients, are tenuous at best, and laughable at worst. It will be difficult to unseat...
May 24, 2007FDA Hydroquinone ban may be premature
Analysis of: FDA May Place Ban on OTC Bleaching Creams | www.carefair.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
The possible ban of over the counter hydroquinone skin bleaching agents may be premature. We have used these agents for 20 years without any significant side effects including ochronosis or paradoxical darkening of the skin. These agents are only modestly effective at best. Most patients still...
May 4, 2007Ceragenix Epiceram product phase 4 results positive
Analysis of: Ceragenix Announces Results from Phase IV Study of EpiCeram(TM) Meet All Primary and Secondary Endpoints | www.irconnect.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
The recent Epiceram phase 4 data comparing it to Cutivate are positive, and bode well for the product. The concept of barrier repair makes sense in light of the recent findings in regards to the genetic basis of atopic dermatitis. Repairing the barrier with Epiceram will reduce inflammation, and the...
April 23, 2007Altabax will have good sales in the impetigo market
Analysis of: FDA Approves Antibiotic Ointment For Children And Adults - Altabax (retapamulin Ointment) | www.medicalnewstoday.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
Altabax (retapamulin) will be a competitive topical agent for impetigo because it is a new molecular entity, Bactroban or mupirocin is generic and cannot compete directly, and it is indicated for children as young as 9 months. The market for a nonoral antibiotic is always good, due to lower side ef...
April 23, 2007ELEVESS gets CE mark approval
Analysis of: Anika Gets CE Mark Certification For Commercial Sale Of Cosmetic Dermatology Product, ELEVESS In European Union | www.tradingmarkets.com
Author: Sunil Dhawan, Clinical Assistant Professor of Dermatology, Stanford University
ELEVESS received its CE mark approval in Europe. The product is entering a crowded field with no real differentiating factors other than having lidocaine as an anesthetic. To release this product in the US without a partnership with an established company will be very hard. It will not be easy to compete...
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