Basal cell carcinoma (BCC) is the most common cancer in the world. It is typically slow growing and usually effectively managed
with surgery. However, BCCs in some patients are unsuitable for surgery or the patient may prefer a nonsurgical treatment. Radiotherapy
is a nonsurgical option for the primary treatment of either low- or high-risk BCCs. It is associated with high cure rates, albeit
somewhat lower than those observed with Mohs micrographic surgery for high-risk BCCs. Not all patients with BCCs are suitable
for radiotherapy. Superficial therapies for BCC include topical imiquimod or 5- fluorouracil and photodynamic therapy (PDT). These
therapies are generally associated with somewhat lower clearance rates and/or higher recurrence rates than surgery or radiotherapy,
although they may be suitable in patients with low-risk BCCs when surgery or radiotherapy are impractical or less appropriate. An
appealing feature of PDT is excellent cosmesis, but PDT is not currently approved by the Food and Drug Administration (FDA), and
regimens are not well standardized. Vismodegib is a first-in-class hedgehog pathway inhibitor and recent addition to the armamentarium
for the treatment of advanced BCC.
J Drugs Dermatol. 2013;12(12):1371-1378.
Acne vulgaris is a common disease of the pilosebacous unit that affects an estimated 40-50 million Americans. Greater than 95% of
teenage boys and between 83% and 85% of teenage girls suffer from acne. The condition frequently continues into adulthood. While
boys more commonly suffer from acne in the teenage years, greater numbers of women suffer into adulthood. It is unclear if the
number of post-adolescent women with acne is rising as compared to the past, or whether women are now seeking out treatment
more than in the past.4 Post-adolescent acne is a significant problem for women. One survey-based United States study found that approximately
50% of women continue to suffer from acne in their twenties, 35% in their thirties, 26% in their forties, and 15% in their
fifties. The prevalence of acne was shown to be higher in women than in men in each of these age groups.7 A similar study from Europe
showed that beyond the age of 23, acne is more prevalent in women than men. In their forties and fifties, 5% and 8% of women suffered
from acne, respectively. Several other studies have provided similar data, showing that larger numbers of adult women suffer
from acne as compared to age matched men. Acne is the number one reason that patients visit a dermatologist. While the mean age
at which patients are seen for acne is 24 years old, 10% of visits occur in patients in their mid-thirties and forties. Approximately two thirds
of dermatology visits for acne are made by women, and one-third of total acne office visits are made by women over 25 years
old. Acne patients suffer from a significant psychological burden, which has been compared to that of patients with systemic diseases
like diabetes, asthma, arthritis, or epilepsy. Up to 50% of adolescents with acne experience disturbances to their psyche, including issues
with body image, anxiety, depression, poor self-esteem, social impairment, and thoughts of suicide. Moreover, acne treatment is
expensive. The average total cost of care related to an acne patient’s visit to the dermatologist is estimated to be $689.14
J Drugs Dermatol. 2013;12(12):1418-1427.
Volume loss is considered to be one of the major contributors to facial aging. Therefore, the restoration of facial volume and contour
changes has become an important treatment approach in aesthetic dermatology in recent years.
In October 2013 the FDA approved for the first time ever an injectable dermal filler for the augmentation of age-related volume loss.
This low-molecular-weight (LMW) 20mg/ml hyaluronic acid (HA) filler competes on the market with poly-L-lactic acid (PLLA) and calcium
hydroxylapatite (CaHA), that have been used off-label for many years to restore age-related volume loss. The safety profile and efficacy
of all three injectables has been intensively evaluated in innumerous clinical studies. However, each volume filler has its benefits and
disadvantages, including usage, method of action and duration of effect that are reviewed in this article.
J Drugs Dermatol. 2013;12(12):1339-1344.
BACKGROUND: Calcium hydroxylapatite filler (CaHA; Radiesse) is a synthetic, non-animal derived product composed of minerals that occur
naturally in bone and teeth. Following its development in the US, initial approval by the US FDA for non-aesthetic indications and CE
marking in Europe, it was used off FDA-labeling for aesthetic purposes. Its use has grown further since its FDA approval in 2006 for
long-lasting correction of moderate to severe wrinkles and folds. It is a popular filler for volume restoration to the face, and also to nonfacial
areas such as the dorsum of the hands.
METHODS: The first article of this two-part series provides an evidence-based review of study data pertaining to the mechanism of action
and biocompatibility of CaHA filler, and its safety, efficacy and tolerability when used for aesthetic purposes. The review includes
data from a number of prospective, controlled comparative studies, from several retrospective studies, and from a meta-analysis of
reported complications from alloplastic filler procedures over a 20-year period. The study methodology and number of study subjects
are sufficiently robust to provide a high Evidence Level for much of the data.
RESULTS: CaHA has good safety, efficacy and tolerability profiles that are comparable to those of hyaluronic acid (HA) fillers. It provides
an initial, immediate volume replacement for up to 12 months followed by longer term correction due to biostimulation, resulting in collagenesis.
Evidence Level II studies show longevity of 30 months or more after nasolabial fold implantation. Other studies demonstrate
the appropriateness of CaHA filler for volume restoration to areas including the mid face, lower face and hands. CaHA is classified as
an adjustable filler, whereas HA is fully reversible by hyaluronidase digestion. For this reason, and also because of CaHA's high viscosity
and elasticity, evidence-based and experiential consensus suggests its avoidance in highly mobile areas (e.g. lips) or in anatomically
unforgiving areas (e.g. the periocular region), where there may be increased incidence of nodules.
CONCLUSION: CaHA filler is safe, efficacious and well-tolerated when used appropriately. It is increasingly recognized that many patients
require pan-facial volume restoration, and that many can benefit from combined treatments. Therefore, CaHA and HA fillers may be
considered complementary rather than competitive to each other. The second article of this series offers a discussion of product characteristics,
scientific principles and injection techniques to optimize treatment with CaHA filler, including special considerations for
avoidance and management of complications.
J Drugs Dermatol. 2013;12(12):1345-1354.
BACKGROUND: Botulinum toxin type A (BoNT-A) has been used for almost 20 years in cosmetic dermatology to reduce dynamic wrinkles
on single or multiple facial areas.
OBJECTIVE: To evaluate the safety and efficacy of full-face treatments with various total doses of abobotulinum toxin A (ABO).
METHODS: A total of 90 participants were enrolled. Subjects had at least two indications for BoNT-A treatments on each third of the face (upper,
middle and lower). They were randomized into 3 groups, with pre-defined total dose range of ABO, varying from 120 to 250 U.
RESULTS: Most of the subjects were women (96.5%). The statistically significant improvement from baseline lasted for more than 24
weeks for glabellar lines, and more than 16 weeks for forehead wrinkles and crow's feet, all P<0.001, with no differences between
groups. The most frequent adverse event (excessive perioral weakness) was related to high dose in the perioral area.
CONCLUSIONS: This is the first study to compare safety and efficacy of different doses of ABO administered to the entire face simultaneously.
As long as the recommended doses are used, concomitant injections of ABO are safe and efficient, with no increase in adverse
J Drugs Dermatol. 2013;12(12):1356-1362.
BACKGROUND: Although botulinum toxin type A (BoNT-A) has been used effectively and safely to reduce facial dynamic wrinkles, few
studies assessed patients' quality of life and satisfaction after treatment.
OBJECTIVE: To assess the quality of life and satisfaction of patients treated with full-face injections of variable doses of abobotulinum
toxin A (ABO).
METHODS: Ninety subjects were randomized into 3 different groups, receiving 120-165 U, 166-205 U and 206-250 U, respectively. WHOQOL-
BREF and Satisfaction and Self-assessment Questionnaire (SSQ) were completed by subjects up to 6 months after treatment.
RESULTS: Most of the subjects were women (96.5%). For the physical domain in WHOQOL, a difference was observed between baseline
and visit 2 (p = 0.036). There was no difference between groups for mean grades regarding amount of wrinkles, beauty, harmony
and symmetry. However, there was a significant difference in the mean grades between visits. Patients' opinions also showed an
improvement in their self-image up to four months after treatment, according to the self-grading.
CONCLUSION: The results presented in this study show improvements in patients' quality of life during the peak of action of BoNT-A
treatment, regarding the physical aspect. In addition, patients reported good satisfaction after a full-face approach.
J Drugs Dermatol. 2013;12(12):1363-1367.
BACKGROUND: Laser lipolysis is a less invasive approach to neck rejuvenation than open surgery or liposuction. Wavelengths utilized for lipolysis
liquefy fat and induce collagen remodeling, which tightens skin. A new Nd:YAG device has recently been developed that emits energy at a
wavelength of 1440nm; this wavelength is more highly absorbed by adipose tissue and water than other wavelengths currently available.
OBJECTIVE: To test the safety and efficacy of a pulsed 1440nm Nd:YAG wavelength and side-firing fiber for the treatment of subcutaneous
fat and skin laxity associated with the aging neck.
METHODS: Twenty-four subjects aged 40 to 65 years underwent laser lipolysis of the submental and anterior cervical areas. An average
of 1205J per 5x5cm square was delivered, with a maximum internal temperature setting of 47 degrees C. Cervicomental Angle Score (CAS),
Global Aesthetic Improvement Scale (GAIS), subject and investigator satisfaction, and safety were assessed.
RESULTS: At six months post-treatment, 79% of subjects had a significant improvement in the CAS (P<.001) and 79% demonstrated an
improvement on the GAIS. Clinical improvement was marked and evident for all but one subject, with physician and patient satisfaction
scores indicating overall satisfaction with the procedure and outcomes. Adverse events were mild and transient with no incidence of
burns, seromas, hematomas, infection, or nerve damage.
CONCLUSION: The 1440nm Nd:YAG device with the side-firing fiber was safe and effective for the treatment of subcutaneous fat and skin
laxity in the neck. This device offers an alternative to selected individuals aged 40 and over who do not wish to undergo rhytidectomy.
J Drugs Dermatol. 2013;12(12):1382-1388.
Resveratrol is a botanical antioxidant with diverse biologic effects. In this paper we will review the unique antioxidant activity of resveratrol
including its effects on mitochondrial function. The molecular signaling of resveratrol and cellular mechanisms that make this
botanical active an important anti-aging ingredient for topical application will be discussed.
J Drugs Dermatol. 2013;12(12):1389-1394.
The proposed terminology Generational Dermatology encompasses prevention and involves medical, cosmetic, surgical and oncologic
strategies over the decades to optimize skin performance throughout the course of a lifetime. Organ failure is the inability of the organ
to perform its determined function as a part of normal physiology and it may be possible to take a Generational preventive approach
toward reducing morbidities associated with the failure of our largest organ, the skin. Outside of skin cancer prevention efforts we
have as a specialty primarily worked on the tertiary prevention realm. I advocate that we can increase our focus on the primary and
secondary tiers where we as Dermatologists have the training and education to identify risk factors and detect early symptoms of skin
disease. I appeal to the house of Dermatology to embrace this concept of Generational Dermatology as preventive medicine for the
evolving aging patient. The practice of Generational Dermatology will decrease patient morbidity and bring down the cost of healthcare.
Our global increased longevity increases the number of elderly worldwide. Longer lifespan means dermatologic needs will increase
as the skin must perform its basic function longer. There are also new unknowns and skin issues which arise from large numbers of
people in the 9th and 10th decades. Generational Dermatology is well suited to be a model for prevention as our patient's age and we can
intervene at any decade. I believe the specialty will increasingly focus on how the skin can optimally perform for a longer period. Lastly,
the practice of Generational Dermatology unifies the house of Dermatology as we need the innovations and input of every subspecialty
to contribute to the health of the people we serve.
J Drugs Dermatol. 2013;12(12):1396-1399.
Two Phase 3, double-blind, randomized, vehicle-controlled parallel studies evaluated the efficacy and safety of desoximetasone spray
0.25%, a super-potent topical corticosteroid, twice daily vs vehicle spray twice daily for 28 days in adult patients with moderate to
severe plaque psoriasis. At baseline and throughout the study, the severity of disease for the psoriatic lesions was assessed using the
Physician Global Assessment (PGA) score and a target lesion was assessed using the Total Lesion Severity Score (TLSS). A designated
psoriatic plaque lesion was selected as the target lesion upon enrollment and evaluated throughout the study to determine the TLSS. To
qualify for study entry, the subject needed to exhibit a PGA score of 3 (moderate) or 4 (severe) for overall disease severity, and a target
lesion with an area of at least 5 cm2 that achieved a combined score TLSS of >=7, with a plaque elevation score of >=3 (at least moderate).
The mean % BSA affected by psoriasis ranged from 13%-17% at baseline.
In both Phase 3 studies, a statistically significantly greater percentage of subjects in the desoximetasone spray 0.25% compared
to vehicle group achieved both Clinical Success and Treatment Success at Day 28. These results, which were the primary efficacy
variables, demonstrated superior efficacy in the active study group for both overall improvement of plaque psoriasis (by PGA) and
in the individual psoriasis lesion (by TLSS) designated at baseline as the most severely involved plaque (target lesion). Assessment
of secondary efficacy variables in both Phase 3 studies showed that subjects receiving desoximetasone Spray 0.25% twice daily
exhibited statistically significantly mean changes from Baseline to Day 28 in PGA, TLSS, and % BSA affected when compared to
subjects receiving vehicle spray twice daily.
Tolerability and safety were assessed at all study visits. No statistically significant differences were observed between study arms
and no major safety signals related to AEs were noted. No stinging and burning were reported with the spray formulation. This Class I
topical corticosteroid has shown to be safe and efficacious in moderate to severe plaque psoriasis.
J Drugs Dermatol. 2013;12(12):1404-1410.
BACKGROUND: Verrucae (warts) are a very common dermatologic disease. They can be of cosmetic concern, cause physical discomfort,
and predispose patients to certain malignancies. Management of warts has traditionally been based on anatomic location, clinical appearance,
and patient preference.
PURPOSE: To investigate trends in the treatment of warts, as well as patient demographics associated with the diagnosis of warts.
Methods: The National Ambulatory Medical Care Survey (NAMCS) was queried for data regarding patient visits associated with the
diagnosis of warts from 1990 to 2009.
RESULTS: There was a significant increase in the use of topical imiquimod during the study period, such that it became the most frequently
used medication for warts. No statistically significant trends were detected regarding the frequency of treatment with medication only, procedure
only, or combination treatment. In terms of patient demographics, there was an upward trend in regards to increasing patient age and
the diagnosis of warts. However, there were no significant trends with respect to patient gender or race and the diagnosis of warts.
LIMITATIONS: Warts not otherwise specified (NOS) was the reported diagnosis for more than eighty percent of patient visits for warts.
Trends in the treatment of plantar warts could not be evaluated as the ICD-9 code designating this diagnosis was recently instituted in
2009. Data from NAMCS are cross-sectional in nature.
CONCLUSIONS: The advent of a new therapy and shifts in population patterns have modified the epidemiologic profile and treatment of warts.
J Drugs Dermatol. 2013;12(12):1411-1415.
INTRODUCTION: Microneedle radiofrequency is a novel method that allows non-thermal penetration of the epidermis followed by RF
coagulation in selected depth of the dermis surrounded by zone of non-coagulative volumetric heating. The first generation of Microneedle
RF applicators used insulated needles. These treatments were limited by a few factors, including low volume of dermal heating,
lack of effect in the papillary dermis and pinpoint bleeding during the treatment. The system tested in this study (EndyMed PRO,
Intensif applicator, EndyMed Medical, Cesarea, Israel) utilizes special extra sharp tapered non-insulated microneedles and a special
pulse mode, allowing full coagulation during treatment and higher effective volume of dermal heat.
METHODS: After Ethics Committee approval, one female pig (Type Large white X Landrace, 34 Kg) was chosen for the study. The animal
was anesthetized using Ketamine, Xylazin and Isofluran. The EndyMed PRO, Intensif applicator (was used for treatment with different
needle depth penetration (1mm-3.5 mm) and in multiple energy settings. Six mm punch biopsies were harvested for histological analysis
at the following time points: immediately after the treatment, 4 days after the treatment and 14 days after the treatment. H&E and
Masson-Trichrome stains were processed.
RESULTS: Visual inspection of the treated skin, immediately after the treatment, revealed arrays of pinpoint erythematous papules
surrounded by undamaged epidermal tissue. Treatment field showed no sign of bleeding. Mild to moderate Erythema and Edema
developed a few minutes after the treatment, varying according to the total energy delivered. The histologies taken 4-day after therapy
showed in all energy settings, dry micro crusts over the treatment zones, with full healing of epidermis. In the 14-day specimens there
was a replacement of the crusts/debris by a normal looking stratum corneum with complete healing of epidermis and dermis.
DISCUSSION: The current in vivo study confirms that the EndyMed PRO Intensif applicator effective and predictable tool to create cylindrical
micro zones of coagulation in the papillary and reticular dermis with minimal damage to the epidermis. The histologies taken 4 days and
14 days after treatment show rapid epidermal renewal with predictable volume of coagulation in dermis related to the length of the needle
and the power used. Coagulation of capillaries during treatment allows a dry treatment field. The predictability of the effect and minimal
downtime may offer a significant advantage over treatments with ablative fractional lasers of insulated RF microneedles.
J Drugs Dermatol. 2013;12(12):1430-1433.
Botulinum neurotoxins are the most popular non-surgical treatments for aesthetic indications, but there is uncertainty about whether
certain formulations are comparable in efficacy and safety and can be substituted for one another by a simple one to one dose
conversion ratio. An expert panel of French practitioners was convened to establish a consensus on the clinical equivalence in efficacy
and safety of OnabotulinumtoxinA (900 KDa) and IncobotulinumtoxinA (neurotoxin free from complexing proteins - 150 KDa).
The consensus was divided into three sections incorporating a biological, bibliographic and clinical analysis of the two toxins. This
included a review of the published data that have directly compared the two toxins for aesthetic indications and a survey of the
panel's extensive clinical experience with the two toxins in terms of efficacy and safety. All panel members reviewed and endorsed
the content of each section. Among this expert panel of French aesthetic physicians and biologists there was consensus that OnabotulinumtoxinA
and IncobotulinumtoxinA are clinically equivalent in terms of efficacy and safety, and that a switch from one drug
to the other can be made using a simple 1:1 conversion ratio.
J Drugs Dermatol. 2013;12(12):1434-1446.
BACKGROUND: Disorders characterized by cutaneous hyperpigmentation (HP) are among the most common complaints in dermatologists'
offices. These patients are also some of the most difficult to treat since current therapeutic regimens have high irritation rates
and mediocre efficacy. Moreover, current regimens have the potential to induce post-inflammatory HP (PIH), a secondary disease that
is more difficult to treat.
OBJECTIVE: To measure the effectiveness of a novel blend of primarily natural ingredients that inhibits all but one of the steps in melanin
synthesis, activation and distribution. Three common types of HP were treated and compared with one of the most commonly prescribed
available regimens. This comprises two prescription products and two nonprescription products containing known depigmenting
MATERIALS and METHODS: The initial trial consisted of 56 females of 3 different races were treated in a 3-armed parallel, investigatorblinded
prospective controlled clinical trial of 18 weeks duration. The treatment phase was 12 weeks long, followed by a 6 week, nontreatment
regression phase. This trial was conducted in the winter at over 6,000 feet above sea level. The natural ingredient (NI) blend
consists of two cosmeceutical products together containing 22 ingredients. A second 1-year open trial of 31 panelists of 3 races was
instituted to document continual improvement using both NI products without irritation and sensitization.
RESULTS: The novel herbal blend regimens had comparable efficacy in treating HP and preventing rebound of mottled HP, dyschromia
and melasma as the commercial regimen containing two prescription products. The 12-month open study demonstrated continued
visible improvement of the HP with NI regimens without irritation and sensitization.
CONCLUSION: The novel primarily natural ingredient product regimens are equally effective in treating three types of cutaneous HP as is
a regimen containing prescription hydroquinone 4%, tretinoin 0.05% and two nonprescription leave on products.
J Drugs Dermatol. 2013;12(12):1449-1454.
One of the hurdles to effectively managing plaque psoriasis is lack of adherence to prescribed treatments. Up to 40% of subjects report
they do not adhere to their medication for a variety of reasons. Earlier response to treatment may be a motivator for subjects to better
adhere to treatment. Clobetasol propionate 0.05% spray (CPS) is a highly potent topical corticosteroid indicated for the treatment of
moderate to severe plaque psoriasis that has efficacy as early as 1 week after initiating therapy. Using data from the 2 CPS pivotal
trials, a post hoc analysis was performed to determine the relationship between week 1 improvements and week 4 treatment success
(defined as a score of 0 [clear] or 1 [almost clear] in overall disease severity [ODS]). Improvements in week 1 ODS and pruritus were
predictive of week 4 treatment success. Subjects who had ODS or pruritus scores of moderate or better at week 1 tended to be
treatment successes at week 4 whereas no relationship between week 1 scores and week 4 treatment success was observed for
those treated with vehicle spray. The results of this post hoc analysis indicate that early improvement correlates to treatment success.
J Drugs Dermatol. 2013;12(12):1456-1460.
INTRODUCTION: IncobotulinumtoxinA (Xeomin®/Xeomeen®/Bocouture®/XEOMIN Cosmetic™; botulinum toxin type A, free from complexing
proteins [150 kDa], NT 201; Merz Pharmaceuticals GmbH, Frankfurt, Germany) is an effective and well-tolerated treatment for a
variety of facial wrinkles.
OBJECTIVE: To determine the efficacy and safety of incobotulinumtoxinA for the treatment of platysmal bands.
METHODS: Women, 35–65 years of age, with platysmal bands scoring 2 or 3 on the validated 5-point Merz dynamic platysmal bands
scale received a total of 60 U incobotulinumtoxinA divided between four platysmal bands (20 U in both medial bands and 10 U in both
lateral bands). Investigator assessments according to the 5-point scale were made at baseline and from standardized clinical photographs
taken at follow-up visits 14±2, 56±7 and 84±7 days after treatment. The global aesthetic improvement scale (GAIS) and a novel
questionnaire were used to assess subject treatment satisfaction. Adverse events were recorded.
RESULTS: Twenty-five women (mean age 51.8 years) were included in the study. With a responder defined as a subject with at least a
1-point improvement from baseline on the dynamic platysmal bands scale, the response rate at maximum contraction was 100% at
Day 14 as assessed by the investigator. By the same definition, a high response rate (96%) was maintained at maximum contraction
at Day 84. Subjects reported that, at Day 84, 86.3% of the maximal effect (defined as the effect on Day 14) persisted. Subject-reported
satisfaction was high, as indicated by the self-assessment on the GAIS and results from the subject satisfaction questionnaire. Treatment-
related adverse events were mild and reversible.
CONCLUSION: IncobotulinumtoxinA is an effective, well-tolerated treatment for platysmal bands, with a high percentage of the treatment
effect maintained at 3 months after treatment. Investigator and subject assessments both indicated high levels of treatment satisfaction.
J Drugs Dermatol. 2013;12(12):1461-1466.
BACKGROUND: Photoaging of the hands is common due to frequent exposure to environmental factors.
OBJECTIVE: To evaluate the efficacy of a topically applied cream formulated with an alpha-hydroxy acid, depigmenting agents, and antioxidants
to improve the appearance of characteristics associated with photodamaged hands.
METHODS: This was a single-site, open-label study of a proprietary topical treatment (Vivité Vibrance Décolleté, Allergan, Inc.) in adult
female subjects with moderate-to-severe photoaging of the hands. The treatment was administered to the hands twice daily over an
8-week period. Treatment efficacy was assessed at baseline and weeks 4 and 8 using the Investigator Global Assessment (IGA) score
based on the percentage coverage and color depth of photodamaged areas. The severity of age spots, freckles, and hand skin discoloration
were also assessed; digital and ultraviolet photography of the hands was performed. Subject-reported assessments of treatment
efficacy were evaluated using a questionnaire administered at week 8. Statistical significance was defined with an α set at P≤.05.
RESULTS: Thirty-five subjects were enrolled with a mean age of 55.6 years; 33 subjects completed the study. The IGA of the appearance
of hand photodamage improved from a mean (standard deviation) score of 5.0 (0.8) at baseline to 3.1 (1.5) and 2.6 (1.3) at weeks 4 and
8, respectively (1=mild; 9=severe). Based on expert-grader evaluation, subjects demonstrated statistically significant improvements
from baseline in IGA at weeks 4 and 8 in age spots and freckling at weeks 4 and 8, (P<.0003) and in skin discolorations at week 8
(P<.05). The majority of subjects reported that they perceived improvements in each of the 9 parameters associated with skin appearance.
No adverse events were reported.
CONCLUSIONS: The appearance of age-related hand pigmentation characteristics were significantly improved at 4 and 8 weeks of treatment.
Subjects reported post-treatment improvements in other characteristics associated with healthy skin.
J Drugs Dermatol. 2013;12(12):1468-1472.