C. William Hanke MD MPH FACP, Kelley Pagliai Redbord MD
Background: Poly-L-lactic acid (PLLA) is an injectable filler used for the treatment of facial fat loss secondary to HIV
and aging. The US FDA approved PLLA for the treatment of HIV lipoatrophy in August 2004.
Observations: Sixty-five patients were treated with PLLA; 27 were HIV positive and 38 were HIV negative. The HIV
patients had more severe facial lipoatrophy at presentation and improved more given their level of severity. The HIV
positive patients required more treatment sessions and more PLLA to reach full correction than the non-HIV patients.
Ninety-four percent of all patients had no complications and the effects of PLLA were similar in both groups. All complications
were temporary and resolved over time. Patient satisfaction metrics indicated that all patients were “very satisfied”
with their treatment. The HIV lipoatrophy patients indicated marked quality of life improvement.
Conclusions: PLLA is a safe, efficacious, and satisfying treatment for facial fat loss associated with HIV and aging.
The injection of botulinum toxin (Botox®, Allergan, Irvine, CA) is the most common cosmetic procedure in the US.
In the past 5 years, its use has climbed over 388%. In 2005, business development managers from Allergan audited 1,695
patient charts from the top 54 cosmetic practices in Canada. Despite the increasing popularity of this nonsurgical treatment,
on average only 57% of patients return for a second injection within 6 months. In the author’s clinical practice
92% of patients return for a second injection in this time frame. This paper will examine various factors that appear to
result in satisfied patients with a high retention rate. This article will show that panfacial botulinum toxin injected in
multiple sites with appropriate dosing improves patient retention.
Bruce E. Katz MD, Sarah Truong MD, Diane C. Maiwald MD, Kathryn E. Frew MD, Dean George MD
Topical 5-aminolevulinic acid (ALA) and various light sources have been used to treat actinic keratoses and acne. Many of
these regimens have required long incubation times due to the penetration qualities of ALA. This study tested the effectiveness
of ALA in producing erythema when applied for 10 minutes after 2 passes of microdermabrasion versus an incubation
time of one hour without microdermabrasion. The areas were treated with a 595-nm pulsed dye laser at 15 J/cm2 or 22.5 J/cm2.
Photographs were taken at 24 and 48 hours after the treatment. The data indicated consistent superior results with the use of
microdermabrasion prior to the application of ALA for 10 minutes. It appears that incubation of ALA with microdermabrasion
for 10 minutes is as effective as, or more so than, ALA applied alone for one hour in producing erythema.
Emil Tanghetti MD, Wm. Philip Werschler MD
It is timely to compare the efficacy and tolerability of 2 actinic keratosis (AK) therapies—5% 5-fluorouracil (5-FU)
cream and imiquimod cream. Thirty-six patients with 4 or more AKs were randomly assigned to receive 5% 5-FU cream
twice daily for 2 to 4 weeks or 5% imiquimod cream twice weekly for 16 weeks. Five percent 5-FU was more effective
than imiquimod in exposing what were presumed to be subclinical AKs, reducing the final AK count (total AK count
declined during the 24-week study by 94% vs. 66%, P<.05), achieving complete clearance (incidence of 84% vs. 24%
by week 24, P<.01), and achieving clearance rapidly. Tolerability was similar except for erythema, which was initially
significantly higher with 5-FU than imiquimod but resolved rapidly and was significantly lower than imiquimod by
week 16. Five percent 5-FU remains the gold standard field therapy for AKs.
James Q. Del Rosso DO FAOCD
Information is limited on the management of truncal acne vulgaris. Survey results suggest that most dermatologists
commonly prescribe oral antibiotic therapy when treating acne involving the chest and back. This article reports therapeutic
outcomes based on an investigator-blinded, randomized, 10-week observational trial completed in patients presenting
with moderate or severe truncal acne vulgaris. One group received treatment with benzoyl peroxide (BP) 9%
cleanser daily, clindamycin 1% foam daily, and doxycycline 100 mg twice daily. The other group received BP cleanser
9% daily and doxycycline 100 mg twice daily without clindamycin 1% foam. Baseline, week 6, and week 10 evaluations
were completed. Efficacy parameters included inflammatory and total lesion count reduction, and investigator global
assessment. Global evaluations of treatment response were recorded and skin tolerability was also evaluated. This trial
was designed to capture observational experience reflective of treatment of patients with truncal acne in a private practice
Tania Cestari MD PhD, Lucie Adjadj, Margaret Hux MSc, Maria Regina Shimizu, Vincent Pierre Rives PharmD
Background: A once-daily fixed combination of hydroquinone, tretinoin, and fluocinolone acetonide (Tri-luma) is a
newly available treatment for melasma.
Objective: To assess cost-effectiveness of triple combination therapy (TCT) applied once daily and hydroquinone alone
applied twice daily in the US, Argentina, Brazil, Chile, and Colombia from a payer’s perspective.
Methods: Clinical data and utilazation of key health resources (medication only) were assessed within an 8-week- clinical trial conducted in Brazil. Total cost per primary success (complete clearing) was used to compare each treatment with not treating and incremental cost effectiveness ratios were used to compare between treatments.
Results and Conclusion: TCT has a 30% better rate of complete clearing than hydroquinone with a lower cost in the hydroquinone. Results were robust to varying assumptions of success rates ans quantity used.
Ellen S. Kurtz PhD, Warren Wallo
Oatmeal has been used for centuries as a soothing agent to relieve itch and irritation associated with various xerotic dermatoses.
In 1945, a ready to use colloidal oatmeal, produced by finely grinding the oat and boiling it to extract the colloidal
material, became available. Today, colloidal oatmeal is available in various dosage forms from powders for the bath
to shampoos, shaving gels, and moisturizing creams. Currently, the use of colloidal oatmeal as a skin protectant is regulated
by the US Food and Drug Administration (FDA) according to the Over-The-Counter Final Monograph for Skin
Protectant Drug Products issued in June 2003. Its preparation is also standardized by the United States Pharmacopeia.
The many clinical properties of colloidal oatmeal derive from its chemical polymorphism. The high concentration in
starches and ?-glucan is responsible for the protective and water-holding functions of oat. The presence of different
types of phenols confers antioxidant and anti-inflammatory activity. Some of the oat phenols are also strong ultraviolet
absorbers. The cleansing activity of oat is mostly due to saponins. Its many functional properties make colloidal oatmeal
a cleanser, moisturizer, buffer, as well as a soothing and protective anti-inflammatory agent.
Adelaide A. Hebert MD and Fran E. Cook-Bolden MD for the Desonide Hydrogel Study Group, Sarmistha Basu PhD, Barry Calvarese MS, Ronald J. Trancik PhD
Low to mid potency corticosteroids remain a cornerstone of therapy for atopic dermatitis (AD). Since AD is most
prevalent in the younger pediatric population and is chronic in nature, safety is of particular concern especially for children
under 2 years of age. A novel desonide (0.05%) formulation was developed in a nonirritating and moisturizing
aqueous gel (hydrogel) that is free of alcohol and surfactants. The safety and efficacy of this new class VI low potency
topical steroid was substantiated in 2 phase III clinical trials in mild to moderate AD subjects aged 3 months to 18 years
(mean age 6.7 years and 30% under 3 years). A total of 425 subjects were treated with desonide hydrogel and 157 subjects
with the hydrogel vehicle. Desonide hydrogel 0.05% was extremely well-tolerated and provided statistically significant
improvements in all primary (P<.001) and secondary (P?.006) efficacy endpoints in both studies. This novel
desonide formulation represents an advancement in the treatment of AD.
Gerald G. Krueger MD, Lawrence Eichenfield MD, J. John Goodman MD, Bernice R. Krafchik MD, Christopher S. Carlin MD, Mei-Lin Pang MD, Richard Croy MA, Mary Elizabeth Holum MS, Eileen Jaracz PharmD, Taiji Sawamoto PhD, James Keirns PhD
Objective: To characterize the pharmacokinetics of tacrolimus after topical application in adult and pediatric patients
with moderate to severe atopic dermatitis from all clinical trials in which tacrolimus blood levels were obtained.
Methods: Tacrolimus ointment 0.03% or 0.1% was applied twice daily. In the adult and pediatric pharmacokinetic studies,
serial blood samples were obtained after single and repeated topical application. During the 12 clinical efficacy trials
of tacrolimus ointment, single blood samples were obtained at various times relative to tacrolimus ointment
Results: In the pharmacokinetic studies, 89% to 95% of tacrolimus whole blood concentration samples were less than
1 ng/mL; mean maximum concentrations ranged from 0.2 to 1.6 ng/mL and mean area under the blood concentrationtime
curves (0-12 hours) ranged from 1.4 to 13.1 ng·hr/mL. Likewise, in the clinical efficacy trials, the majority (85%-
99%) of tacrolimus concentration samples were less than 1 ng/mL.
Conclusions: Tacrolimus ointment is associated with minimal systemic absorption and no evidence of systemic accumulation
in patients with moderate to severe atopic dermatitis and extensive disease.
Michael H. Gold MD, Mitchel P. Goldman MD, Julie Biron
The crucial role of growth factors and cytokines in cutaneous wound healing is well described, but there has been little
investigation into their use for skin rejuvenation. A novel skin cream containing a mixture of human growth factors
and cytokines was recently marketed for skin rejuvenation. The mixture was obtained through a biotechnology
process using cultured human fetal skin cells, which originate from a dedicated cell bank originally established for the
development of products in wound healing. The cream significantly reduced periorbital and perioral wrinkles, as well
as improved skin texture of the chin after one month of treatment, which confirms the beneficial use of growth factors
and cytokines for skin rejuvenation reported in 2 earlier studies. After 60 days of twice-daily application, 83% of the
subject showed an improved average wrinkle score in the eye area, while 50% showed an improved average wrinkle
score in the mouth area. In order to exclude a placebo effect, the efficacy of this product should be confirmed with a
double-blind, randomized, placebo-controlled study. Also, the difference between mixtures of growth factor and cytokines should be further elaborated.