THERAPEUTICS UPDATE New products and pharmacologic developments
New Products
ENVY MEDICAL UNVEILS SILKPEEL3
Envy Medical, Inc. launched SilkPeel3 to combine noninvasive exfoliation with the delivery of condition-specific
solutions. These solutions are targeted toward the individual skin needs and can address acne, dryness, dull skin,
aging, sun damage, and pigmentation. SilkPeel3 offers
advancement in ease-of-use, functionality, and efficacy. Its
“IndiviDUAL Infusion” dual-port design allows patients to
load two serum solutions at once, allowing for more tailored
treatments that address multiple skin concerns. SilkPeel3
can now treat blemishes, dry skin, dark spots, and other
common skin concerns in one session. Additional improvements include the ergonomically improved “Plexus” hand
piece with the option of new disposable medical-grade
stainless steel treatment tips that make the treatment
more comfortable and effective by eliminating incomplete
passes and delivering more powerful and precise pneumatic
vacuum results. The new SilkPeel3 offers a wider treatment
range, expanding the system’s efficacy to multiple body
applications as well. When treating the body, SilkPeel3’s
higher vacuum power settings improve the appearance of
cellulite and restore skin elasticity, while the lower settings
help address stretch marks, truncal acne, and rough patches.
Envymedical.com
MARINI LUMINATE EYE GEL FROM JAN MARINI
SKIN RESEARCH
Jan Marini
Skin Research is
introducing Marini
Luminate Eye Gel,
specifically designed
for the delicate
eye area. Marini
Luminate Eye Gel
reduces under
eye circles and
discoloration while
firming crepey skin and erasing the appearance of fine lines
and wrinkles. The eye gel addresses the unique challenges
of the eye area including thinning skin, hyperpigmentation,
sun-damage, vascular changes, leakage and discoloration
from blood breakdown, iron deposition staining, and
uneven texture. Marini Luminate Eye Gel is formulated
to address pigmentation and brightening issues with a
combination of Chromabright, Linoleic and Lionlenic acids,
as well as retinol. The eye gel offers specific technology to
address wrinkles, pigment, vascular discolorations, puffiness,
and barrier function. Janmarini.com
ZO SKIN HEALTH INTRODUCES
OCLIPSE SMART TONE
ZO Skin Health, Inc. launched
Oclipse Smart Tone SPF 50, a new
broad-spectrum sunscreen with
patented color-bursting beads that
match any skin tone. Developed by
Zein Obagi, MD, Oclipse Smart Tone
offers UVA and UVB all-day sun
protection, while also helping to shield
the skin from cell damaging high
energy visible (HEV) light. The multitasking formula addresses every need,
from helping skin support its own
natural repair process to helping tackle
irritation and pigmentation, all while
drenching the skin with conditioners
to soften and soothe. Oclipse Smart
Tone contains micro-beads that burst
when rubbed into skin to create
customizable color on any skin tone, creating a perfect tint
to be worn alone or as a make-up primer. The sunscreen
is formulated with extracts of Petasites Japonicus Root
Extract and Beta Glucan to minimize irritants that can cause
redness. The organic sunscreen is also infused with Argania
Spinosa Kernel Oil to provide moisture and aid in lipid
repair. To discourage the formation of new pigmentation
and freckles, it’s fortified with a vitamin C. Zoskinhealth.com
SKINBRELLA OFFICIALLY LAUNCHED
Skinvisible Inc., through its wholly-owned subsidiary
Kintari International Inc., launched Skinbrella. Skinbrella
is a broad-spectrum, SPF 30 sunscreen made with the
company’s patented topical delivery technology Invisicare.
It provides 80 minutes of water resistance; the highest
designation allowed by the FDA. It meets the requirements
to be labeled “broad spectrum,” signifying it provides both
UVA and UVB protection. Avobenzone, the only UVA
absorber approved by the FDA, degrades in the sun in less
than two hours resulting in less skin protection. Skinbrella
has proven to deliver eight hours of photostability of
avobenzone, a unique advantage for which a patent was
granted by the United States Patent and Trademark Office.
Kintari.com
MAY 2015 PRACTICAL DERMATOLOGY 63
THERAPEUTICS UPDATE New products and pharmacologic developments
Therapeutics Focus: Fungal Infections
STUDY EVALUATES EFFICACY AND SAFETY OF
1064-NM ND:YAG LASER IN TREATMENT OF
ONYCHOMYCOSIS
A recent study was conducted to evaluate the efficacy and
side effects of onychomycosis treatment with a long-pulsed
1064-nm Nd:YAG laser. Sixty-four onychomycotic nails (35
patients) were evaluated. Involved nails were treated with a
long-pulsed 1064-nm Nd:YAG laser in four sessions at oneweek intervals. A potassium hydroxide examination and fungal
culture were performed every week during the treatment
course and at a one-month follow-up visit. If either test was
positive for a pathogenic organism, a second treatment cycle
was performed. If the two tests produced negative results,
each affected nail was followed up at three- and six-month
visits after completion of the second treatment protocol. In
cases of resistance (positive for a pathogenic organism after
completion of the second treatment cycle), the onychomycotic
nails were excluded from the study and treated by standard
methods. Of 64 nails evaluated, 59 completed the first cycle of
treatment and 24 (40.7 percent) demonstrated mycological
clearance at the one-month follow up. Thirty-five of the 59 nails
(59.3 percent) were positive for a pathogenic organism and
underwent a second treatment cycle. Upon completion of the
second cycle, 28 nails remained enrolled, and the mycological
test results were negative in nine nails (31.2 percent). For all
nails that completed the first or second treatment cycle, the
overall cure rates at the one-, three- and six-month followup visits were 63.5 percent, 57.7 percent and 51.9 percent,
respectively. Side effects were mild and limited to erythema
and swelling after the laser procedure. The researchers
concluded that long-pulsed 1064-nm Nd:YAG laser therapy
is safe and effective for the treatment of onychomycosis, but
acknowledged that a larger sample size and longer follow-up
period are needed to confirm these findings.
—J Dermatolog Treat. 2015 Apr 17:1-5.
EVALUATING EFINACONAZOLE IN PATIENTS
WITH ONYCHOMYCOSIS AND COEXISTING
TINEA PEDIS
To evaluate the efficacy of efinaconazole topical solution
10% in patients with onychomycosis and coexisting tinea
pedis, researchers analyzed 1,655 patients, aged 18 to 70 years,
randomized (3:1) to receive efinaconazole topical solution
10% or vehicle from two identical multicenter, double-blind,
vehicle-controlled 48-week studies evaluating safety and efficacy.
The primary end point was complete cure rate (zero percent
clinical involvement of the target toenail and negative potassium
hydroxide examination and fungal culture findings) at week 52.
64 PRACTICAL DERMATOLOGY MAY 2015
Three groups were compared: patients with onychomycosis
and coexisting interdigital tinea pedis on-study (treated or left
untreated) and those with no coexisting tinea pedis. The study
found that treatment with efinaconazole topical solution 10%
was significantly more effective than vehicle use irrespective
of the coexistence of tinea pedis or its treatment. Overall,
21.3 percent of patients with onychomycosis had coexisting
interdigital tinea pedis at baseline, with 61.1 percent of these
patients receiving investigator-approved topical antifungal
agents for their tinea pedis in addition to their randomized
onychomycosis treatment. At week 52, efinaconazole complete
cure rates of 29.4 percent were reported in patients with
onychomycosis when coexisting tinea pedis was treated
compared with 16.1 percent when coexisting tinea pedis was
not treated. Both cure rates were significant compared with
vehicle, and in the latter subgroup, no patients treated with
vehicle achieved a complete cure.
The study authors concluded, “Treatment of coexisting
tinea pedis in patients with onychomycosis enhances the efficacy of once-daily topical treatment with efinaconazole topical solution, 10%.”
—J Am Podiatr Med Assoc. 2015 Apr 13.
CLINICAL TRIAL EVALUATES SQUALAMINE
OINTMENT FOR TINEA CAPITIS TREATMENT
A Phase II randomized, double-blind, placebo-controlled
clinical trial was conducted to test the efficacy and safety of
a three-week squalamine ointment regimen for the treatment of tinea capitis. Males aged six to 15 years presenting
with tinea capitis were treated with either topical squalamine
ointment or placebo for three weeks. The primary endpoint
was complete clinical cure. The secondary endpoints were the
occurrence of local and/or systemic adverse events, mycological cure, and partial clinical response. Prospective follow-up of
clinical adverse events was performed daily. Five patients were
treated with 1% squalamine ointment and 15 were treated
with placebo. No complete cure was observed. No clinical or
biological adverse event was recorded. A significantly better
hair-growth score, indicating a partial clinical improvement
of the tinea capitis, was observed in the patients treated with
squalamine compared to those treated with placebo. The
researchers found that this three-week squalamine ointment
regimen was well tolerated and showed partial clinical activity for the treatment of tinea capitis. They noted that further
studies are needed to evaluate the efficacy of topical squalamine alone or in combination with an antidermatophyte
drug to treat tinea capitis. n
—Mycopathologia. 2015 Apr;179(3-4):187-93.