Multiple types of anti-aging treatments are required to address the various etiologies of facial aging. Soft-tissue augmentation provides
a minimally invasive option for patients seeking to look younger. However, due to changes in facial skin, musculature, fat and
bone, anti-aging treatment requires a multifaceted approach. Injectable fillers may be combined with neurotoxins to resolve superficial
wrinkles and restore facial volume. These modalities may be used with laser resurfacing or chemical peels to address epidermal
and superficial dermal problems. Combining injectable soft-tissue augmentation treatments allows clinicians and patients to take
advantage of the benefits of each modality and to address the multiple effects of facial aging. This review is based on clinical experience
and a MEDLINE search for articles about volume replacement and soft-tissue augmentation. It provides a rationale that supports
the use of combination techniques/products for soft-tissue augmentation.
J Drugs Dermatol. 2011;10(2):125-132
Tatjana Pavicic PhD
Clinic and Polyclinic for Dermatology and Allergology, Ludwig-Maximilians-University, Munich, Germany
Background: A monophasic, highly crosslinked hyaluronic acid dermal filler offers further treatment options for deep lines.
Objective: To investigate the efficacy and tolerability of Belotero.
Methods and Materials: A total of 149 patients received injections. Efficacy was assessed on the Wrinkle Severity Rating Scale
(WSRS) and the Global Aesthetic Improvement Scale (GAIS). Adverse events were recorded at each evaluation session.
Results: Mean WSRS improved significantly (P<0.001) by 1.9 score points without any decline throughout the 12-week period.
Improvement was found in 89.9 percent of patients on the (GAIS), 59.7 percent of whom were designated as very much/much
improved. Investigator and patient satisfaction was stated in more than 90 percent of cases as excellent/good. Adverse events, exclusively
localized to the injection area, occurred in 85.9 percent of patients immediately after injection and declined to 12.8 percent
in week 2. None were serious.
Conclusion: The findings indicate the benefit of the highly cross-linked, monophasic hyaluronic acid dermal filler, especially in the
treatment of patients with deep and extremely deep folds. Overall, the filler appears to be well tolerated. This evaluation raised no
major safety concerns.
J Drugs Dermatol. 2011;10(2):134-139.
Nowell Solish MD FRCPa and Arthur Swift MD FRCSb
Background: There have been few systematic investigations of the effectiveness, safety and tolerability of aesthetic lip augmentation
using hyaluronic acid (HA) fillers.
Objectives: Evaluate the effectiveness of small gel particle hyaluronic acid filler (Restylane® Injectable Gel [SGP-HA]; Medicis Aesthetics
Inc., Scottsdale, AZ) in lip augmentation using the Medicis Lip Fullness Scale (MLFS). Assess subjective improvement in lip
appearance using the Global Aesthetic Improvement Scale (GAIS).
Patients, Materials and Methods: Investigators treated 21 adults. The primary efficacy endpoint was an increase in lip fullness at
least one grade on MLFS at eight weeks post-treatment. Adverse events were reported using patient diaries.
Results: Sixteen of 18 evaluable subjects (89%) had an improvement at least one grade on MLFS in both lips. MLFS and GAIS scores
were consistent, suggesting clinically significant aesthetic improvement. Adverse effects were transient and mostly mild to moderate
Conclusion: Lip augmentation with SGP-HA was well tolerated and resulted in clinically meaningful increases in lip fullness.
J Drugs Dermatol. 2011;10(2):145-149.
Thomas J. Stephens PhD,a James H. Herndon Jr. MD FAAD,b Luz E. Colón MS CCRC CCRA,c Ronald W. Gottschalk MD FRCPCc
Objective: To compare the functional stability of Cetaphil® UVA/UVB Defense SPF 50 as measured by its ultraviolet B sun protection
factor (UVB-SPF) and ultraviolet A protection factor (UVA-PF) values following exposure to natural sunlight versus the UVB-SPF and
UVA-PF values of unexposed product.
Methods: These two randomized, controlled, evaluator-blinded, single-center trials were conducted according to the methods outlined
in the 2007 Proposed Amendment to the Final Monograph, “Sunscreen Drug Products for Over-the-Counter Human Use.”
Sunscreen samples were applied to glass plates and exposed to ultraviolet radiation in the form of natural sunlight in four minimal
erythemal doses (MED) ranging from 2–16 MED (42–336 mJ/cm2). Three test sites were identified on the back of each study subject.
Exposed sunscreen (one of four doses), unexposed sunscreen, and a UVB-SPF 15 control sunscreen were applied to the three test
sites in a randomized fashion, followed by UV irradiation of incremental doses. Erythema and pigment darkening responses were
assessed immediately following UV exposure and again 16–24 hours (erythema) or three to 24 hours (pigment darkening) after exposure.
UVB-SPF and UVA-PF values were calculated for the exposed and unexposed samples.
Results: The calculated UVB-SPF and UVA-PF values for all test samples (exposed and unexposed) were >50 and >9, respectively,
which were greater than the stated UVB-SPF and UVA-PF values on the product label. No differences were observed between the
exposed and unexposed samples in UVB-SPF or UVA-PF.
Conclusion: The UVA and UVB protection using standard evaluation techniques of Cetaphil UVA/UVB Defense SPF 50 remains stable
despite exposure of the sunscreen to natural sunlight containing UVB ranging from 2–16 MED (41–336 mJ/cm2) and coexistent UVA.
J Drugs Dermatol. 2011;10(2):150-155.
Robert T. Brodell MD, Suzanne Bruce MD, Charles P. Hudson MD, Jonathan S. Weiss MD,Luz E. Colon MS, Lori A. Johnson PhD, Ronald W. Gottschalk MD FRCPC
Background: Psoriasis is a hyperproliferative and inflammatory skin disorder that affects roughly 2 percent of the worldwide population.
Clobetasol propionate is the most common corticosteroid used to treat moderate-to-severe psoriasis but the potential for side
effects limits its long-term use. Topical vitamin D, which is used to treat mild-to-moderate psoriasis, has been shown to be safe when
used daily for up to 52 weeks. To date, very few studies exist evaluating the use of clobetasol propionate in a regimen with calcitriol
to manage moderate-to-severe disease over time.
Objectives: To evaluate the efficacy and assess safety of a regimen of sequential topical treatments with clobetasol propionate
0.05% spray for up to four weeks followed by calcitriol 3 μg/g ointment for eight weeks in the management of moderate-to-severe
Methods: This was a multi-center, open-label study in subjects aged 18–80 years with moderate-to-severe plaque psoriasis at baseline.
Subjects applied clobetasol propionate 0.05% spray twice daily for up to four weeks. At the end of four weeks, if the subject’s
overall disease severity (ODS) was assessed as clear, almost clear, mild or moderate, subjects started treatment with calcitriol 3 μg/g
ointment twice daily. Twice-daily treatment with calcitriol 3 μg/g ointment continued for eight weeks (until week 12) or unless the
subject’s ODS was assessed as severe or returned to the baseline score, at which time it was discontinued. Subjects were evaluated
at baseline and at weeks 2, 4, 8 and 12.
Results: Of the 305 subjects enrolled, 170 subjects completed the full 12-week study with no major protocol deviations and comprised
the per-protocol (PP) study population. Treatment success, defined as at least one grade improvement in ODS at week 12
compared to baseline, was achieved in 84.1 percent of subjects. The percent body surface area affected (% BSA) decreased from 7.1
percent at baseline to 3.9 percent at week 12 (P<0.001). The sequential treatment regimen was well tolerated with no unexpected
adverse events. Most reported adverse events and cutaneous irritations were mild in severity.
Conclusions: The results of this study indicate that the 12-week regimen of clobetasol propionate 0.05% spray treatment for four
weeks immediately followed by an eight-week treatment phase with calcitriol 3 μg/g ointment is efficacious and safe for the management
of moderate-to-severe plaque psoriasis.
J Drugs Dermatol. 2011;10(2):158-164.
C. William Hanke MD,a Neil Swanson MD,b Suzanne Bruce MD,c
Brian Berman MD PhD,d James Kulp BS,e Sharon Levy MDe
Objective: Assess long-term, sustained, complete clearance of actinic keratoses after treatment with imiquimod 3.75% or 2.5%
cream using two two-week or three-week cycles of daily dosing.
Methods: Adults with five to 20 baseline actinic keratoses who achieved complete clearance at the eight-week post-treatment visit
in four phase 3 placebo-controlled treatment studies were followed for an additional 12 months.
Results: For imiquimod 3.75% and 2.5% cream, respectively, complete clearance was sustained for 12 months in 17/42 (40.5%)
and 13/39 (33.3%) subjects from the two-week cycle studies, and in 23/48 (47.9%) and 16/37 (43.2%) subjects from the three-week
cycle studies. There were no safety concerns during the follow-up.
Conclusion: In subjects with a median of eight to nine baseline actinic keratoses who achieved complete clearance after treatment
of the full face or balding scalp with topical imiquimod 3.75% cream, complete clearance of all lesions (baseline, recurrent or new)
was sustained in ≥40 percent of subjects for at least 14 months after the last dose. Clinicaltrials.gov identifier NCT00668733.
J Drugs Dermatol. 2011;10(2):165-170.
Matthew T. Woods MD, Peter A. Brown BS, Shahana F. Baig-Lewis MPH, Eric L. Simpson MD MCR
Objective: To determine the effect a novel formulation of fluocinonide cream on skin barrier function in subjects with atopic dermatitis.
Design: The authors performed an open-label, investigator-blinded, side-by-side, controlled trial examining skin barrier function before
and after a two-week course of a class I, super-potent topical steroid.
Setting: Outpatient university-based dermatology clinic in Portland, OR.
Subjects: Twenty-five subjects aged 12 or older with a diagnosis of moderate, severe, or very severe AD were recruited for this study.
Intervention: Fluocinonide 0.1% cream, a novel formulation of a class I super-potent topical steroid was applied to all affected areas,
except a control site, once daily for two weeks or until clear. The control target site was treated with the vehicle once daily.
Main Outcome Measure(s): The study’s primary outcome was change in skin barrier function as measured by basal transepidermal
water loss (TEWL) in acute lesional skin from baseline as measured at two weeks.
Results: TEWL readings significantly decreased (reflecting improved barrier function) in both the active and control target sites. The active target site decreased 14.35±16 mg/cm2 per hour; 95 percent confidence interval, P<0.001. The control target site decreased 8.75±11.80 mg/cm2 per hour in 25 subjects; 95 percent confidence interval, P<0.001. Skin electrical capacitance also improved significantly, reflecting improved stratum corneum hydration with therapy. Pruritus, clinical severity, and quality of life scores all showed significant improvement by the end of the study.
Conclusion: The authors have shown that short-term treatment with a novel formulation of 0.1% fluocinonide led to significantly
improved barrier function as measured by basal TEWL in subjects with active moderate to severe AD. These data suggest short-term
treatment with AD with a super-potent corticosteroid improves skin barrier function.
J Drugs Dermatol. 2011;10(2):171-176.
Brian Somoano MD, Basil M. Hantash MD PhD, Edgar F. Fincher MD PhD, Peggy Wu MD, Hayes B. Gladstone MD
Background: Recent studies have suggested that a series of low-energy, single-pass ablative laser resurfacing micropeels can reduce
photoaging with decreased downtime. This randomized, prospective single-blinded trial sought to determine the ideal settings
of sequential erbium:yttrium-aluminum-garnet (Er:YAG) laser treatments that maximize efficacy and patient satisfaction.
Methods: Forty-six subjects with mild-to-moderate facial dyschromia and rhytides were evenly randomized to two Er:YAG treatment arms. Patients in the lower fluence (LF) (2.5 J/cm2) and higher fluence (HF) (3.8 J/cm2) groups each received three one-pass, full-face
treatments one month apart. Patient and investigator assessments of rhytides, dyschromia and global appearance were performed
at baseline and at four, eight and 20 weeks using a nominal scale from 1–4. Adverse events and patient satisfaction were also evaluated.
Results: Patient scores showed rhytid improvement only with HF treatments. Investigator scores at three months post-treatment
showed dyschromia was significantly improved in both study arms, with a 24 and 36 percent reduction for the LF and HF groups, respectively.
Global appearance scores improved by 25 and 32 percent, respectively. A trend towards greater post-procedure erythema
and time-to-erythema resolution was observed in the HF group. Mild peeling was the most common adverse event. Individuals who
underwent LF treatments were more likely to pursue future treatments.
Conclusion: Both settings resulted in moderate but significant improvement in dyschromia, although only HF treatment improved
rhytides. The decreased downtime of LF treatments made this the preferred choice of patients.
J Drugs Dermatol. 2011;10(2):179-176.
Omar A. Ibrahimi MD PhD Andrew A. Nelson MD Jennifer K. Tan, MD
Resident Rounds is a new section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds will feature three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program, (2) a section presenting study materials used by residents at the program, and lastly, (3) a section designed to highlight recent interesting cases seen at the institution. The inaugural issue of Resident Rounds will feature the Harvard Combined Program in Dermatology. The editor of Resident Rounds is Omar A. Ibrahimi, MD, PhD. Dr. Ibrahimi is a recent graduate of the Harvard Combined Program in Dermatology and currently a fellow in Mohs, Laser and Cosmetic Surgery at the University of California Davis. If you are interested in highlighting your training program in a
future issue, please contact Dr. Ibrahimi at [email protected]
Kalindi Raval PharmD, Jennifer H. Lofland PharmD MPH PhD, Heidi C. Waters MS MBA, Catherine Tak Piech MBA
Plaque psoriasis is a chronic, inflammatory skin disease that can be difficult to treat. Traditional systemic agents, topical agents,
phototherapy and biologic therapies can be used for patients with psoriasis. The authors reviewed published results from a variety
of sources in order to better understand the effects of psoriasis treatments on patient satisfaction, patient adherence, healthcare
resource utilization and productivity. Patients with psoriasis consider many factors when evaluating therapies, including the time for
the therapy to be effective, cosmetic issues common with topical therapies and travel to and from phototherapy centers. Satisfaction
with and adherence to biologic therapies appears to be greater than for traditional therapies. Although biologic therapies are generally
more expensive than are traditional, these agents may contribute to decreased healthcare utilization and increased productivity.
J Drugs Dermatol. 2011;10(2):189-196.
Justin Ko MD, Elena Hawryluk MD, Charles R. Taylor MD
No abstract details for the moment.
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is
our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is
available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic
community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share
their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug
Administration (FDA) approval. We trust you will find this information beneficial to your practice and research.
Jennifer K. Tan MD, Adam D. Lipworth MD, Andrew A. Nelson MD, Artur Zembowicz MD PhD, Samuel L. Moschella MD; James Click MD, Sarah Gee MD, Raul Cortes MD, Lydia Gedmintas MD, Joseph F. Merola MD, Vivian Bykerk MD, Arturo Saveedra MD PhD MBA
No abstract details for the moment.