Michael Jarratt, MD, Debra Breneman, MD, Alice B Gottlieb, MD, Yves Poulin, MD, Yin Liu Y, PhD, Valerie Foley, Pharm D
Psoriasis is a chronic, papulosquamous condition that affects up to 2% of the U.S. population. Approximately 50% of patients with
psoriasis have involvement of the scalp.
This was a multicentre, randomized, vehicle-controlled, double-masked and parallel-group study. The aim was to evaluate the efficacy
and safety of clobetasol propionate shampoo, 0.05% versus its corresponding vehicle in subjects aged 12 years and older with moderate
to severe scalp psoriasis over a treatment period of 4 weeks. Recurrence of scalp psoriasis was assessed during a two week follow-up
A total of 142 subjects were treated. Results after 4 weeks demonstrated that clobetasol propionate shampoo, 0.05% was with a similar
safety profile significantly more effective than its vehicle. The novel short contact shampoo formulation of clobetasol propionate
is convenient and efficacious and minimizes systemic exposure while being efficient, safe and well-tolerated in the treatment
of moderate to severe scalp psoriasis.
R Balkrishnan PhD, A P Kelly MD, A McMichael MD, H Torok MD
Melasma is a common hyperpigmentation of the face or neck that can have severe adverse psychological and emotional effects on
affected individuals. Although a variety of treatments have been used over the years, results have typically been less than satisfactory.
An open-label, community-based trial was undertaken at 393 centers in the United States, enrolling 1290 patients representing a
broad range of races/ethnicities and all Fitzpatrick skin types, to evaluate the efficacy and safety of a new melasma treatment that
combines fluocinolone acetonide 0.01%, hydroquinone 4.0%, and tretinoin 0.05% (FA+HQ+RA) in a hydrophilic cream formulation.
An additional objective of the study was to assess the impact of this therapy on the quality of life. Efficacy and safety were evaluated
at 4 and 8 weeks, and changes in a variety of quality of life parameters were analyzed at the conclusion of the study. All measures
of efficacy showed that FA+HQ+RA significantly (p<0.0001) improved melasma at 4 weeks with further improvement at 8 weeks across
all races/ethnicities and Fitzpatrick skin types. The treatment was safe and well tolerated. After 8 weeks of therapy, patients reported
that FA+HQ+RA had provided a variety of benefits that had enhanced their quality of life.
Birgit Woerle MD, C William Hanke MD MPH FACP, Gerhard Sattler MD
A number of soft tissue filling agents are available in the U.S. and Europe. In Europe, poly-L-lactic acid was approved for soft tissue
augmentation and correction of wrinkles in 1999. The clinical results from this synthetic implant may last up to two years. In
this article, we report our experience using poly-L-lactic acid for correction of facial lipoatrophy and wrinkles in 300 patients since
1999. poly-L-lactic acid is an ideal, resorbable filler material for soft tissue augmentation, especially in the lower one-half of the face.
The aesthetic results are excellent and long-lasting. Clinical results and side effects are generally technique-dependent. The clinical
results using poly-L-lactic acid for soft tissue augmentation are comparable to autologous fat grafting. However, surgical fat harvesting
is not necessary, and treatment can be extended to elderly individuals and patients with infectious diseases who have little body fat.
Vicky Kwan Wong BA, Brian Fuchs MD, Mark Lebwohl MD
Desonide (as a cream, ointment, or lotion formulation) is widely used for the treatment of steroid-responsive dermatoses. This paper
provides information on its safety record, as determined from adverse event reports and published trial results. A pharmacovigilance
program, initiated in 1992 for all countries where desonide is available, collected reports of adverse events associated with topical desonide
over nine years. Published accounts of randomized, controlled trials of desonide in comparison with hydrocortisone were
reviewed. Sixty-two reports have been collected; most were from consumers and were not medically substantiated. There were no
serious reactions directly attributable to desonide treatment and the majority of events reported were classified as expected local reactions,
generally mild in nature. This level of reporting is against a background of extensive prescribing of desonide; almost one million
packs are dispensed per annum in the US alone. The excellent safety profile of desonide revealed by this pharmacovigilance
program is supported by a review of published clinical trial results.
Darrell Rigel MD, Christopher Nelson MD, Stacy Smith MD, Neil Swanson MD, John Wolf, MD
A clearance rate of all occurrences ?75% for actinic keratoses (AK) lesions is an accepted efficacy endpoint for topical agents. This
efficacy endpoint has not been assessed for 3.0% diclofenac sodium gel (Solaraze™).
We evaluated the efficacy and tolerability of 3.0% diclofenac sodium gel in the treatment of AK for a treatment period of 90 days and
a 30-day follow-up period.
This is a multicenter, single-arm, open-label study in patients diagnosed with five or more AK lesions contained in 1 to 3 blocks (5
cm2) on the forehead, central face, or scalp. Patients were treated twice daily with a topical application of 3.0% diclofenac sodium gel
for a period of 90 days with a follow-up assessment at 30 days post-treatment. The presence or absence of target lesions and new
lesions was assessed at each visit a long with a global improvement index score.
Of the 76 patients who entered the study, 67 (88%) patients completed the study. At Day 90 of treatment, 78% of patients had ?75%
AK lesion clearance based on the target lesion number score (TLNS). Improving to 85% of patients demonstrating ?75% AK lesion
clearance at Day 120 (follow-up). Improvement was also demonstrated by 100% AK lesion clearance based on the TLNS clearance
(Day 90 of treatment: 41%; Day 120 [follow-up]: 58%). Similar improvements were shown in cumulative lesion number score (CLNS),
which included new as well as targeted AK lesions within the designated treatment areas, at Day 90 and Day 120 (follow-up).
Investigators’ assessment based on Investigator Global Improvement Index (IGII) confirmed the efficacy of 3.0% diclofenac gel in the
clearance of AK lesions. A total of 39 patients (51%) experienced at least 1 adverse event considered to be related to 3.0% diclofenac
sodium gel during the study. Dry skin and rash at the application site were most common reported adverse events, and most of
these adverse events were mild or moderate in severity.
The topical application of 3.0% diclofenac sodium gel provides a safe and effective approach for the treatment of AK.
Telithromycin (Ketek™, Aventis) is a semisynthetic antibacterial agent belonging to a class of drugs called ketolides, which are a variation
on the existing class of antibiotics known as macrolides (e.g., erythromycin), whose structure includes a 14-molecule ring. The
FDA approved telithromycin for use as a treatment for upper respiratory tract infections in April of 2004. Its primary use is to treat
community-acquired pneumonia and sinusitis. Telithromycin fulfills a role that has arisen due to the rise of microbial resistance to
existing macrolides and appears to be effective against macrolide-resistant Streptococcus pneumoniae. The defining differentiating
characteristic of the ketolides as opposed to other macrolides is the removal of the neutral sugar, L-cladinose from the 3 position of
the macrolide ring and the subsequent oxidation of the 3-hydroxyl to a 3-keto functional group. Telithromycin seems to be an effective
antibiotic in the treatment of a variety of skin infections, although double-blind trials have not proven this and currently no indication
for treatment of skin infection is being sought from the FDA. Telithromycin also has excellent penetration into the female
genial tract and could be useful for treating infections in this area.
Jaggi Rao MD, Kristina E Paabo PA-S, and Mitchel P Goldman MD
Cellulite is the unsightly dimpling and nodularity frequently found on the thighs and buttocks of post-adolescent women. The anatomy
and pathophysiology of this unwanted condition is poorly understood. The paucity of research studies to date has led to a dormancy
of scientifically based therapeutic options that are effective and tolerable.
The purpose of this study is to evaluate the tolerability and efficacy of a novel topical agent based on a plausible pathophysiologic
mechanism in the treatment of cellulite, and to compare the efficacy of this agent used in combination with an occlusive bioceramiccoated
neoprene garment, to the agent used alone without occlusion. We will also review the current understanding of the etiology
and nature of cellulite and summarize available treatment options.
Twenty women with a moderate degree of cellulite were entered into a four-week, double-blinded, randomized trial where an anti-cellulite
cream was applied to the affected sites on a nightly basis. Each subject was randomized to receive occlusion by a bioceramiccoated
neoprene garment on either the right or left leg, with the contralateral side serving as a control with no occlusion. High-quality
digital photography was taken before treatment and after four weeks at various angles, with tangential full-spectrum lighting. Four
blinded, independent dermatologist reviewers assessed the photographs for improvement. Subjects completed questionnaire forms
to assess tolerability and efficacy.
Of the 17 subjects who completed the study, 76% noticed an overall improvement in their cellulite, with 54% reporting greater improvement
in the thigh that received garment occlusion. The average measured decrease in thigh circumference was 1.2 cm, noting a 1.3
cm reduction with occlusion and a 1.1 cm reduction without occlusion. Upon review of the pre- and post-study photographs, the
dermatologist evaluators found an improvement in 65% of treated legs with occlusion, and 59% of treated legs without occlusion.
Further, the evaluators found the occluded thighs to show greater improvement than the non-occluded thighs in 65% of subjects.
The topical agent used in this study was found to be effective in reducing the appearance of cellulite. Bioceramic-coated neoprene
garment occlusion potentiates the effect of this topical agent in cellulite reduction. The success of this study validates the pathophysiologic
mechanism used to formulate the topical agent used.
Aditya K Gupta MD PhD FRCP(C), Karyn Nicol HBMSc
Sulfur has antifungal, antibacterial, and keratolytic activity. In the past, its use was widespread in dermatological disorders such as
acne vulgaris, rosacea, seborrheic dermatitis, dandruff, pityriasis versicolor, scabies, and warts. Adverse events associated with topically
applied sulfur are rare and mainly involve mild application site reactions. Sulfur, used alone or in combination with agents such
as sodium sulfacetamide or salicylic acid, has demonstrated efficacy in the treatment of many dermatological conditions.