New Drugs 2013: Part 1

Part 1

Ted Rosen, MD


Modified release prednisone (Rayos) is now on the market. Why would this be a reasonable therapeutic choice for healthcare providers? It’s important to remember that for many inflammatory diseases, proinflammatory cytokines peak overnight; yet, steroid administration is often administered in the morning. This treatment delays the bioavailability for about four hours. The idea is to take this at bedtime (~10:00pm) so that the medication is then active during peak cytokine secretion and; therefore, reduces morning symptoms associated with various inflammatory diseases.


Rayos is approved for steroid-responsive inflammatory disorders such as RA, PsA, AS, polymyalgia and asthma (when steroids are indicated).  It is available in 1, 2 and 5mg doses.  Larger size tablets will be come available soon. The adverse events associated with Rayos are comparable with those of regular prednisone including hypertension, cataracts, glaucoma, bone density decrease, mood swings, GI irritation, ulceration or perforation, and TB re-activation. No live vaccines should be administered during treatment.



Cellulite is seen in 90 percent of women over the age of 40. The question then remains…. Can cellulite be cured? The Cellulaze Laser was approved as a device in January 2012. It is a side-firing 1440nm wavelength laser that works by destroying fibrous bands and vaporizing excessive fat. Dr Rosen feels that it may actually work and there may be a reasonable rationale for its use in that, it is only one treatment, it may have a long-lasting effect, a rather short recovery time and minimal scarring. However, there is not a lot of published data (n= 10) and it is rather costly ($5,000-$12,000 per treatment). There have also been various instances of bruising, swelling, pain, and numbness associated with its use.


Vismodegib, a hedgehog pathway inhibitor, is a novel therapy for aggressive or metastatic basal cell carcinoma (BCC), where surgery or radiotherapy may be deemed inappropriate.

This treatment has dermatologists thinking a little more like oncologists, i.e. is the tumor stable? is it shrinking?  In other words, some response is a good thing even if it isn’t a complete response. It is important to remember that even with ongoing therapy, there may be a recurrence of BCC. This is a unique and outstanding therapy and has a place in the dermatological armamentarium. It really offers the small subset of refractory, recurrent or metastatic BCC patients a new option.

Recent FDA Safety Warnings that all Dermatologists Should Keep in Mind

  • Minoxidil 15%- may cause hypotension
  • Vicrelis and Incivek (protease inhibitors for Hepatitis C, used in conjunction with Interferon) Incivek- serious skin reactions, including fatalities
    •  All patients who develop a skin reaction should receive urgent medical care
  • Nature Relief-Recall because calcium oxide that burns the warts and moles can burn the skin
  • Bleaching creams/skin lightening products- may contain mercury resulting in renal injury, CNS injury, fatigue, anorexia, weight loss, or a rash


New Drugs 2013: Part 2

Part 2

Neal Bhatia, MD

Over the last few years, dermatology has become reliant on botany with regards to some of the newer therapies. These include:

  • Ingenol Mebutate “Petty Spurge”
  • Polypodium leucotomos
  • Sinecatechins (Veregin)

Ingenol Mebutate 

Ingenol Mebutate is a topical gel derived from the Euphorbia peplus plant, and is approved for its effect on actinic keratosis. (Of note, Ingenol Mebutate is applied twice a day for the body, three times per day for the face)

Polypodium leucotomos

Polypodium leucotomos is an aquatic fern origination in Central America. For centuries it has been used by native Americans because of it anti-inflammatory effects.  Polypodium leucotomos  has significant antioxidant activity and can positively affect photodamaged skin. The product is marketed as Heliocare and can be purchased over-the-counter or through a physician for about $30.00. It does not have an FDA indication for chemoprevention or treatment of AK/NMSC.

Sinecatechins (Veregin)

Catechins have antioxidant, antiviral and immune-stimulatory effects.  The graph below demonstrates the antioxidative activity of Veregen for the clearance of external genital warts.


This product is probably not an option for the treatment of AKs based on the studies conducted; however, it could be used for Molluscum, maybe even more so than genital warts.


Photodynamic therapy

What is the appropriate incubation time Levulan PDT Treatment?  Using a noninvasive dosimeter, PpIX fluorescence 5 replicates were taken at 20-minute intervals for two hours following ALA application. Results demonstrated improvement of 48% of all lesions by 20 minutes, 92% of lesions by one hour, and 100% of lesions by two hours. PpIX accumulation correlated with changes in lesional erythema post-PDT and high levels PpIX are produced in AKs in two hours.

Regarding incubation and light strategies the label says to incubate for 14 hours, i.e., treat the day before and stay indoors to avoid activating the light. Reality tells us to incubate for two hours if possible, though one hour is more realistic. The light is on for 16 minutes and 40 seconds which is enough exposure to provide a 10 J/cm2 light dose.

But, are there better options??

A Phase II study of photodynamic therapy for Levulan topical solution plus blue light versus Levulan topical solution vehicle plus blue light using spot and broad area demonstrated that ALA was statistically superior to vehicle at 12 weeks for all treatment groups. The one-hour data seems to be slightly lower in efficacy indicating some dose response. There also appears to be some long-term benefit to Broad-Area versus Spot application, in that a much higher number of Broad Area patients who are clear at 12 weeks remain clear at 24 weeks compared to Spot treated patients.

Clinical Pearls

  • Assess available devices and practical applications
  • Understand rationale for therapy
  • Choose patients wisely and avoid over-exposure


Atrapro versus Aurstat: Battle of the Hydrogels

Microcyn is the active ingredient in Atrapro, it enhances wound healing by inducing vasodilation and it has an anti-inflammatory affect. Microcyn is also a biomodulator that denatures endotoxin and causes stabilization of mast cells; therefore, leading to a direct anti-itch effect. It’s important that dermatologists recognize that Microcyn is different than antibiotics in that it works via multiple mechanisms of action. Microyn causes damage to cell wall, membrane and intracellular components. In an open-label pilot study looking at the results of the use of Atrapro Antipruritic Hydrogel alone, data demonstrated a reduction in pruritus severity by day 14 in 88 percent of the patients (N = 17). There was a subjective reduction of itching by day three in 82 percent of the patients, and 76 percent of the patients improved at day 14 by investigator grade.


Aurstat Hydrogrel, which was cleared by the FDA as a medical device, contains hypochlorous acid and sodium hypochlorite. Hypochlorous acid and sodium hypochlorite function as preservatives; hence, providing an anti-itch effect. A study by Draelos, et al. demonstrated the ability of Aurstat Hydrogel to reduce pruritus in patients with mild to moderate atopic dermatitis over a seven-day period (N = 20).


What’s the difference between these products?

  • Both studies authored by Dr. Zoe Draelos
  • Both have small number of patients (17 vs. 20)
  • Both have short durations (14 d vs. 7 d)
  • Atrapro has two vehicles, Aurstat has a kit
  • Atrapro works to prevent mast cell degranulation to stabilize itch, Aurstat acts      via hypochlorous acid
  • Both claim anti-microbial activity without antibiotic properties


Take Home Message:

Both of these products may reduce the need for steroids and antibiotics and that may be where we see their potential utility in clinical practice.


Nuvail- A New Approach to Damaged Nails

Nuvail, a new and unique patented polymer that leaves a breathable, elegant, invisible film when applied to nails, was recently approved for restoring the health of nails. Polyureaurethane is the active ingredient.

What’s the rationale for polyureaurethane?

  • Polymer adheres to nail plate
  • Solvents evaporate upon application
  • “Vapor permeable” waterproof seal formed with nail and periungual skin folds (provides a better feel for the patient)
  • Changes in nail from sealant effect impairs further growth of fungal elements
  • Drying effect of nail plate and bed from waterproof seal


Clinical data demonstrated a 60 percent improvement in nail color, nail plate involvement, onyycholysis, thickness, and hyperkeratosis after six months of treatment.

The recommended application of Nuvail is qHS, the product should be applied in even strokes to affected nail plate (in entirety), proximal and lateral folds, and the distal tip. It is important that patients allow the product to dry completely before applying pads or clothing. Patients should know that nail polish may worn on top of Nuvail; however, nail polish should not be applied until Nuvail is completely dry. Prior to the next application of Nuvail, nail polish should be removed. The affected nails should be cleaned with nail polish remover once a week.

Overall Conclusions

  • Assess history of dosages, onset of eruption, and patterns
  • Monitor systemic issues of patients
  • Carefully assess labels of “allergy” and do not hesitate to reconsider label