Mark G. Rubin MD, Jeffrey S. Dover MD FRCPC FRCP,Richard G. Glogau MD, David J. Goldberg MD JD, Mitchel P.Goldman MD, Joel Schlessinger MD FAAD FAACS
Introduction: A new U.S. Botulinum toxin type A (BoNT-A) has been shown to be safe and effective when administered once, but
there is a paucity of clinical evidence regarding long-term use.
Objective: To evaluate the long-term efficacy and tolerability of repeated treatment with BoNT-A in the correction of moderate-tosevere
Study Design/Methodology: Multicenter, phase 3, randomized, placebo-controlled, double-blind study comparing the efficacy of
BoNT-A (50 units) with placebo upon re-treatment of glabellar lines following two-to-three cycles of open-label BoNT-A treatment in
Results: At endpoint, BoNT-A produced a significantly higher proportion of responders versus placebo. The incidence of treatmentemergent
adverse effects (TEAEs) was slightly lower during additional treatment cycles; the frequency was comparable between
BoNT-A and placebo groups.
Conclusion: Multiple treatment cycles of BoNT-A were well tolerated in the majority of patients, and there was no tachyphylaxis
seen during the study duration of up to 23 months.
Dilek Seckin MD, Asli Aksu Cerman MD, Ayfer Yildiz MD, Tulin Ergun MD
Background: Recent research demonstrated that vitamin D, apart from calcium-related actions, has antiproliferative, prodifferentiative
and immunomodulatory activities.
Objective: To determine whether actinic keratoses may benefit from the antiproliferative and prodifferentiative effects of topical
Materials and Methods: The study was an investigator-blinded, half-side comparison trial. Patients applied calcipotriol cream to one
side and Ultrabase® cream as placebo to the other side of the scalp and/or face for 12 weeks. The total number of actinic keratoses
(AKs), diameters and total scores of the target lesions were determined at each visit.
Results: Nine patients were included, eight of whom completed the treatment. There was a statistically significant difference between
the total number of AKs at baseline and at week 12 on calcipotriol applied side whereas no difference was detected on placebo
applied side (p=0.028 vs p=1.00). The mean total score of the target lesions reduced significantly at week 12 on calcipotriol side;
however, no significant reduction was found on placebo side (p=0.017 vs p=0.056). Although side effects were more common on
calcipotriol side, the difference was not statistically significant.
Conclusion: Topical calcipotriol may show promise in the treatment of actinic keratoses. More studies are needed to confirm its
Brian Berman MD PhD, Catherine Harrison-Balestra MD,Oliver A. Perez MD, Martha Viera MD, Adriana Villa MD,Deborah Zell MD, Claudia Ramirez MD
Background: No effective treatment exists for permanent keloid removal. When applied to excised-sites, imiquimod 5% cream
reduces keloid recurrence. Case series suggest the tolerability and efficacy of imiquimod 5% application to sites of shaved keloids;
however, this has not been verified in placebo-controlled studies.
Objective: To determine the tolerability and compare the efficacy of imiquimod 5% and vehicle cream in lowering keloid recurrence
Methods: Twenty randomized, shaved keloids were administered imiquimod 5% or vehicle cream nightly for two weeks, and then
given three times a week under occlusion for one month. Pain, tenderness, pruritus and keloid recurrence were evaluated at baseline,
week 2, week 6 and 6 months.
Tolerability: Tenderness and pain were significantly (p= 0. 02 and p= 0. 02, respectively) higher at week 2 in the imiquimod group
than for those treated with vehicle cream. Pruritus did not attain statistical difference between the groups.
Efficacy: At 6 months, keloid recurrence rates were 37.5% (3/8) in the imiquimod group and 75% (3/4) in the vehicle group,
Conclusion: Imiquimod was well tolerated. There was not enough statistical power to detect a significant difference in six-month
keloid recurrence rates between the two treated groups.
Arisa Ortiz MD, Laila Elkeeb MD, Anne Truitt MD,Rasha Hindiyeh MD, Lisa Aquino MD, Minh Tran,Gerald Weinstein MD
Background: Current treatments for acne rosacea are often associated with unsatisfactory outcomes and adverse effects.
Objective: To determine the efficacy and tolerability of a new moisturizing lotion for improving the clinical signs and symptoms of
mild-to-moderate acne rosacea.
Methods: In a 12-week, open-label study, a moisturizing lotion containing furfuryl tetrahydropyranyladenine as PRK124 (0.125%,
Pyratine-XR™, Senetek PLC, Napa, CA) was applied twice daily to subjects with mild-to-moderate rosacea. Improvement in the appearances
of erythema and papules were assessed by the treating physician. Skin barrier function was measured by transepidmal
water loss after treatment. Tolerability and cosmetic outcome were evaluated by patients.
Results: Twenty-one participants completed the study. Overall clinical improvement was observed in 80% of subjects, with most
showing mild-to-moderate improvement. Erythema, papule counts, and telangiectasia were reduced. The reduction in TEWL was
significant at weeks 4 (p = 0.01), 8 (p < 005), and 12 (p<0.001). Rosacea symptoms (burning, stinging, dryness) were progressively
reduced, with reduction in dryness achieving statistical significance at weeks 4 (p = 0.035), 8 (p = 0.037) and 12 (p = 0.016). Treatments
were well tolerated and cosmetic outcomes were acceptable. Treatment-induced irritation was not observed.
Conclusion: The new moisturizing lotion containing furfuryl tetrahydropyranyladenine as PRK124 shows a continued trend toward
improvement of skin barrier function and the appearances of erythema and papules associated with mild-to-moderate rosacea during
12 weeks of treatment.
Katherine H. Flanagan MD and Dee Anna Glaser MD
Primary focal hyperhidrosis (HH) is a chronic disorder of excessive sweating. A single-center, open-label study was performed to
determine the efficacy and safety of 15% aluminum chloride (AC) in 2% salicylic acid gel base (SAGB) Hydrosal® in adults with
moderate-to-severe primary axillary HH. Thirty subjects were given 15% AC in 2% SAGB to apply to their bilateral axillae nightly for
the first week, then twice-weekly application as tolerated. The primary objective was change in mean Hyperhidrosis Disease Severity
Score (HDSS) score from baseline to week 4. Participants who achieved an HDSS score ≤ 2 were designated as “responders.” Mean
change in HDSS from baseline to week 4 was 1.32 (p=0.0001). At week 4, 21 of 29 (72%) were responders, and at week 12, 18 of
25 (72%) were responders. Based on these results, 15% AC in 2% SAGB may be an effective, high-strength AC topical therapy for
treatment of patients with moderate-to-severe axillary HH.
Jill Waibel MD, Kenneth Beer MD, Vic Narurkar MDand Tina Alster MD
Fractional resurfacing has become an increasingly popular treatment for photodamage. Non-ablative and ablative fractional
resurfacing modalities both have a variety of different devices that may be utilized for treatments. Each modality has its own benefits
and drawbacks. In this article, the authors offer preliminary observations from hands-on experience with several different ablative
fractional lasers presently available.
George Cohen MD and Annyce Treherne MD
The advent of highly active anti-retroviral therapy (HAART) has extended the lives of patients affected by human immunodeficiency
virus (HIV) disease. A common cutaneous side effect of HAART is facial lipoatrophy. The hollowed out cheeks, temples and eye
sockets often lead to a gaunt cachetic facies which can be a disconcerting stigmata of the disease and a psychological burden to
the patient. Autologous fat transfer (ATF) is a minimally invasive surgical procedure that can temporarily improve the appearance in
patients with facial lipoatrophy. Other corrective procedures (e.g., injectable fillers) are available, but, to date, the ideal procedure for
permanent correction of facial lipoatrophy has not been found.