BACKGROUND: Single-day, high-dose systemic antiviral drugs are effective in the treatment of labial herpes (herpes labialis [HL]). Aciclovir
Lauriad® mucoadhesive buccal tablet (ABT) is an innovative drug delivery system providing high and prolonged exposure to aciclovir in
the oral cavity, supporting its evaluation as a single low dose in HL.
METHODS: In this multicenter double-blind placebo-controlled patient-initiated trial, 775 patients with recurrent HL were randomly
assigned to either a single application of ABT 50 mg or a matching placebo as soon as prodromal symptoms occurred. The primary
endpoint was the time to healing (TTH) of primary vesicular lesion (modified intention-to-treat population). Other endpoints included
incidence of blocked episodes, duration of herpes episodes, and incidence and time to next recurrence evaluated during a 9-month
follow-up period (intention-to-treat population).
RESULTS: With ABT 50 mg, median TTH of primary vesicular lesion was reduced (7 days vs 7.3 days, P=.015), the incidence of blocked
herpes episodes was increased by 24.2% (34.9% vs 28.1%; P=.042), and the median duration of herpes episodes was reduced (5.6
days vs 6.4 days, P=.003). During the 9-month follow-up period, recurrence of herpes lesions was less frequent (64.2% vs 73.6%;
P=.027) and delayed (205 days vs 165 days, P=.041) in the ABT 50 mg. Both treatments were safe.
CONCLUSION: A single application of ABT improves all endpoints of HL and might modify its clinical course in decreasing the incidence
and delaying the onset of the next recurrence.
J Drugs Dermatol. 2014;13(7):791-798.
BACKGROUND: Econazole nitrate is a broad-spectrum topical antifungal with activity against a variety of dermatophytes and yeasts. A
new topical dosage form, econazole nitrate topical foam 1%, utilizing patented Proderm Technology® has been developed for treatment
of interdigital tinea pedis.
OBJECTIVE: To evaluate econazole nitrate foam 1% versus foam vehicle for treatment of interdigital tinea pedis.
METHODS: Two randomized, double-blind, parallel-group, vehicle-controlled, multicenter studies enrolled males and females ≥12 years
old with a clinical diagnosis of interdigital tinea pedis and baseline fungal culture positive for a dermatophyte. Subjects applied econazole
nitrate foam 1% (n=246) or foam vehicle (n=249) once daily for 4 weeks. The primary endpoint was proportion of subjects achieving
a complete cure (negative KOH, negative fungal culture, complete resolution of all signs and symptoms) at 2 weeks post-treatment
(Day 43). Secondary endpoints included mycologic cure (negative KOH and negative culture) and effective treatment (mycologic cure +
no or mild erythema and/or scaling and all other signs and symptoms absent).
RESULTS: The complete cure rate at Day 43 was 24.3% for econazole nitrate foam 1% vs 3.6% for foam vehicle. In addition, higher rates
of mycologic cure (67.6% vs 16.9%) and effective treatment (48.6% vs 10.8%) were observed with econazole nitrate foam 1% versus
the foam vehicle. There were few adverse events and only nasopharyngitis and headache were experienced by >1% of subjects. No
serious adverse events were reported for econazole nitrate foam 1%.
CONCLUSIONS: Econazole nitrate foam 1% exhibited superiority over foam vehicle for the primary and secondary endpoints with a high
mycologic cure rate for all pathogens evaluated. Econazole nitrate foam 1% was safe and well tolerated with a safety profile comparable
with the foam vehicle. Econazole nitrate foam 1% presents a novel alternative for the management of tinea pedis.
J Drugs Dermatol. 2014;13(7):803-808.
Currently, topical minoxidil and finasteride are the only treatments that have been FDA approved for the treatment of female pattern
hair loss and androgenetic alopecia. Given the incomplete efficacy and sife effect profile of these medications, some patients utilize
alternative treatments to help improve this condition. In this review, we illustrate the scientific evidence underlying the efficacy of these
alternative approaches, including biotin, caffeine, melatonin, a marine extract, and zinc.
J Drugs Dermatol. 2014;13(7):809-812.
BACKGROUND: Onychomycosis is a fungal infection of the nail apparatus that can be challenging to treat due to the modest efficacy of
existing antifungal therapies and a high rate of relapse and recurrence.
OBJECTIVES: To investigate the efficacy and safety of efinaconazole 10% solution in pooled Phase III clinical trial participants with mild
to moderate onychomycosis.
METHODS: Phase III clinical trials data from NCT01008033 and NCT01007708 were pooled. Efficacy analysis for the primary and secondary
outcome variables was conducted using the mITT population and analysed using Cochran-Mantel-Haenszel tests. Subgroup analysis
was conducted for prognostic factors that may affect drug efficacy. Safety analysis was conducted on all recipients of a single drug dose.
RESULTS: Efinaconazole 10% nail solution was superior to vehicle for all primary and secondary outcome measures assessed. Complete
cure was 18.5% vs 4.7% P<0.001 [mITT] and mycological cure was 56.3% vs 16.6%, P<0.001 [mITT]. Complete or almost complete
cure and treatment success were achieved in 27.7% and 47.2% compared to 7.9% and 18.2% with vehicle, respectively (P<0.001
[mITT]). In all subgroups, efinaconazole 10% solution had statistically higher cures rates compared to vehicle. Higher complete cure
rates were observed in women and individuals with mild disease (≤33% involvement), but not in any other subgroup assessed. Treatment
associated adverse events in the efinaconazole 10% solution group were similar to vehicle and limited to local site reactions (2%).
CONCLUSIONS: The findings from this pooled analysis suggest that efinaconazole 10% solution may become the preferred topical agent
for mild to moderate onychomycosis.
J Drugs Dermatol. 2014;13(7):815-820.
BACKGROUND: Patients with moderate to severe rosacea often seek treatment to reduce erythema and vascular markings. Few studies
have looked at the effectiveness of the novel treatment, brimonidine topical gel 0.33%, trademark name Mirvaso®, in the treatment
of rosacea. We report the use of optical coherence tomography (OCT) scanning to monitor the effectiveness of Mirvaso® on in
vivo skin. OCT is a non-invasive optical imaging technique that can provide high-resolution imaging of vessel and cellular morphology.
OCT may be useful as a pre-treatment assessment tool for identifying possible morphologic features in the skin that may serve as
outcome predictors. OCT may also serve as a monitoring tool in the treatment of rosacea.
OBJECTIVE: To examine and describe how OCT skin morphology changes when exposed to brimonidine topical gel 0.33% in the
treatment of erythematotelangiectatic rosacea.
METHODS: Normal in vivo telangiectasias and erythematous patches and papules were examined prior to treatment clinically, dermatoscopically,
and through OCT scans. Brimonidine topical gel 0.33% was applied to the face and OCT images were acquired
at defined time intervals: baseline; immediately (<5 minutes) after application; 4 hours after application; and after 2 weeks’ once
daily application. OCT morphology was then described.
RESULTS: OCT imaging showed an increase in the mean gray value (MGV), a measure of dermal reflectivity, corresponding to a decrease in
dermal edema. MGV measurements for the nasal telangiectasia were: baseline, MGV 10,471 (standard deviation [SD] 6,847); immediate,
MGV 15,634 (SD 8,983); after 4 hours, MGV 16,357 (SD 7,647); and after 2 weeks, MGV 15,505 (SD 6,870). MGV measurements for the
chin erythema were: baseline, MGV 8,850 (SD 4,969); immediate, MGV 10,799 (SD 5,266); after 4 hours, MGV 12,419 (SD 6,714); and
after 2 weeks, MGV 13,395 (SD 6,170). No significant change in vessel lumen diameter was appreciated. Vessel lumen diameter for the
facial papule ranged from 0.13 mm at baseline, 0.09 mm immediately after treatment, 0.09 mm after 4 hours, and 0.11 mm after 2 weeks.
CONCLUSIONS: OCT scanning showed a decrease in the dermal hyporeflectivity of the dermis consistent with a decrease in dermal
edema. The OCT scans obtained did not show any significant change in vessel lumen diameter. These results may reflect an increase
in vascular tone, which can be attributable to the clinical improvement and decreased erythema noted in the patient. This
technology could potentially be used for the non-invasive in vivo monitoring of other topical treatments.
J Drugs Dermatol. 2014;13(7):821-826.
BACKGROUND: Treatment of hidradenitis suppurativa has been studied, but treatment strategies and outcomes have not been reported
for a large community-based group of patients.
OBJECTIVE: We sought to determine the treatments most commonly prescribed and the performance of all systemic and surgical treatments
used in hidradenitis suppurativa patients in Olmsted County, Minnesota, treated over a 40-year period.
METHODS: A retrospective chart review was performed to evaluate hidradenitis suppurativa treatments in 376 episodes with 115 Olmsted
County patients seen by a clinician at Mayo Clinic in Rochester, Minnesota, between 1968 and 2008. Treatment episode outcomes
were recorded from clinical notes for the 73 treatment episodes that had a follow-up period of more than 30 days.
RESULTS: Systemic antibiotics alone were prescribed most frequently in 70.0% of episodes. Systemic antibiotics alone improved 39 of
49 treatment episodes (79.6%), including 13 episodes (26.5%) when the disease was fully cleared. All 5 of 5 episodes (100%) of surgical
treatment alone improved, including 4 (80%) in which the disease was fully cleared. Surgery in combination with systemic antibiotic
treatment yielded improvement in 5 episodes (71.4%), with 2 episodes (28.6%) showing complete clearance.
CONCLUSION: Systemic antibiotics were the most frequently prescribed treatment type in 115 patients over a 40-year period. Both systemic
antibiotic therapy and surgical treatment are effective in disease management.
J Drugs Dermatol. 2014;13(7):827-831.
BACKGROUND: Early follow-up visits improve patient adherence, but the actual scheduling behavior of physicians is not known.
PURPOSE: To characterize the timing of first follow-up visits in US dermatologic practice.
Methods: Patients with a diagnosis of psoriasis, acne, or atopic dermatitis were identified in the 2003-2007 MarketScan Medicaid
database. Factors affecting the length of time before first follow-up were assessed using a Cox proportional hazards model.
RESULTS: Mean length of time to the first follow-up visit was 153 days for adults and 142 days for children with psoriasis; 151 days for
adults and 218 days for children with acne; and 161 days for adults and 209 days for children with atopic dermatitis. Black and those
other than white patients were less likely than whites to receive early follow-up in psoriasis and acne, but more likely in atopic dermatitis.
Dermatologists were more likely to schedule early follow-up visits than nondermatologists.
LIMITATIONS: The database includes only Medicaid patients. The rate of non-attendance at scheduled visits could not be determined.
CONCLUSIONS: Most physicians are missing the opportunity to maximize patient adherence by scheduling early follow-up visits. Contact
by email or phone may be beneficial for physicians who cannot schedule early follow-up.
J Drugs Dermatol. 2014;13(7):833-836.
BACKGROUND: Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis.
OBJECTIVE: This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis.
METHODS: A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were
randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28
and 42 (ie, days 14 and 28 posttreatment) based on clinical signs (erythema, scaling, pruritus) and mycology (KOH, fungal culture). The
primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments.
RESULTS: Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with
1.9% (2/103) of patients treated with vehicle (P<0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle.
LIMITATIONS: This study was conducted in a relatively small population under controlled clinical trial conditions.
CONCLUSION: Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with
J Drugs Dermatol. 2014;13(7):838-846.
BACKGROUND: Although biologic therapies have been shown to be more effective than traditional systemic therapies in clinical trials for
the treatment of psoriasis, the drug survival time and reasons for discontinuation of biologics in clinical practice have not been compared
with those of conventional systemic therapies.
DESIGN: Retrospective, cross-sectional.
METHODS: All patient visits coded for psoriasis (ICD-0 696.1) in the clinical practice of 2 dermatologists from January 1 2008 through
January 4 2012 were included in this retrospective data analysis. The practice is a comprehensive psoriasis care center in the northeastern
United States serving a metropolitan population of over 4 million people. Patients were divided by treatment type: biologic or
traditional systemic. Treatment failure was defined as discontinuation of treatment course for any reason. Patient time to failure for each
therapy was calculated, as were previous treatments and reasons for treatment discontinuation.
RESULTS: One hundred and fifty-nine patients who underwent 284 courses of treatment were studied. Forty-eight percent of biologics
failed in an average of 242 days, compared with 75% of traditional systemics (P<.0001), which failed in an average of 143 days
(P<.0001). Infliximab had the longest survival time (292 days), and ustekinumab had the smallest failure rate (39%). Reasons for discontinuation
differed significantly between biologics and systemics, with biologics being discontinued more often due to loss of efficacy
(P=.0014), and systemics failing significantly more frequently due to adverse events (P<.001). Adverse events were observed most
frequently with methotrexate and infliximab, while golimumab had the highest rates of both loss and lack of efficacy.
CONCLUSION: Biologics had longer survival times and lower failure rates than traditional systemics in the treatment of psoriasis. Biologics
were more likely to be discontinued due to loss of efficacy, and systemics were more likely to fail due to adverse events.
J Drugs Dermatol. 2014;13(7):848-853.
BACKGROUND: Pityriasis (tinea) versicolor is a superficial fungal infection of the stratum corneum caused by Malassezia species. The
diagnosis is made clinically by its classic appearance of round or oval macules with fine scale that may be hyperpigmented or hypopigmented.
Diagnosis may also be confirmed with microscopic evaluation of skin scrapings that reveal both short, stubby hyphae, and
spores under KOH preparation. Ketoconazole is an important treatment of pityriasis versicolor but is primarily used in cream formulas.
A foam vehicle has been shown to improve drug absorption through the stratum corneum and distribution in the skin. This study has
assessed the safety and efficacy of ketoconazole 2% foam in treatment of pityriasis versicolor.
METHODS: Ketoconazole 2% foam was evaluated in a single-center, open-label, one-arm pilot study which enrolled eleven subjects to
gain 10 evaluable subjects aged 21 years and older with a clinical diagnosis of tinea versicolor and positive KOH using calcofluor. The
subjects came for 4 scheduled visits (baseline, week 1, week 2, and week 4) and were instructed to apply ketoconazole 2% foam to all
affected areas twice daily for 2 weeks. At each visit, mycological and clinical assessment of a target area was done, along with static
global assessment and body surface area estimation of the disease in each subject. Patient questionnaires were given at baseline and
at week 2 to rate pruritus and satisfaction with the foam.
RESULTS: At the week 2 visit, following the treatment period, three out of ten evaluable subjects had negative skin samples prepared
with KOH/calcifluor. Of these three, one subject later showed recurrence of fungal elements consistent with tinea versicolor at the
week 4 follow-up visit. The other negative subjects remained negative and four additional subjects tested negative at week 4. Three
subjects with positive samples at week 4 had only yeast forms without hyphae present. Investigator ratings of the target area were
averaged for each clinical feature and demonstrated improvement in scale, hyper- or hypopigmentation, erythema, and induration
throughout the study. Average pruritus score increased slightly 1 week after the baseline visit, but then improved steadily over the
remaining visits. The investigator’s static global assessment rating showed improvement from mild to moderate disease at baseline to
minimal or no disease at week 4 in 7 subjects. The remaining subjects showed neither improvement nor progression of the disease
throughout the study. One out of the eleven subjects enrolled did not complete the study. One subject noted mild skin burning sensation
after application of medicine. Post-treatment patient questionnaires indicated overall satisfaction with the foam vehicle.
LIMITATIONS: This was a single-arm, open-label, noncomparative trial.
Conclusion: Ketoconazole 2% foam improved overall clinical assessment and microscopic evidence of pityriasis versicolor in all subjects
with favorable patient feedback regarding the novel foam vehicle.
J Drugs Dermatol. 2014;13(7):855-859.