Azelaic acid (AzA) 15% gel is approved for the treatment of rosacea in the US, but also has approval for the treatment of
acne vulgaris in many European countries where it has demonstrated success. Two randomized, multicenter, controlled clinical
trials compared the effects of AzA 15% gel with those of topical benzoyl peroxide 5% or topical clindamycin 1%, all
using a twice-daily dosing regimen. The primary endpoint in the intent-to-treat analysis was a reduction in inflammatory
papules and pustules. AzA 15% gel resulted in a 70% to 71% median reduction of facial papules and pustules compared
with a 77% reduction with benzoyl peroxide 5% gel and a 63% reduction with clindamycin. AzA 15% gel was well-tolerated.
In addition, a 1-year European observational study conducted by dermatologists in private practice evaluated the safety
and efficacy of AzA 15% gel used as monotherapy or in combination with other agents in more than 1,200 patients with
acne. Most physicians (81.9%) described an improvement in patients’ symptoms after an average of 34.6 days, and 93.9%
of physicians reported patient improvement after an average of 73.1 days. Both physicians and patients assessed AzA 15%
gel to be effective with 74% of patients being “very satisfied” at the end of therapy. AzA 15% gel was considered “welltolerated”
or “very well-tolerated” by 95.7% of patients. The majority of patients were more satisfied with AzA than with
previous therapies. AzA 15% gel represents a new therapeutic option for the treatment of acne vulgaris.
Actinic keratosis (AK) is common and lesions may progress to squamous cell carcinoma. The choice of therapy depends
mainly on 2 factors: the efficacy of therapeutic options and the number of lesions present. Cryotherapy alone is suitable
for treating a few lesions, whereas topical medications, photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA),
or either in combination with cryotherapy are appropriate for treating multiple (>15) lesions. When combinations are
necessary, the total cost to treat multiple AKs to 100% clearance becomes important. This report provides a simple pharmacoeconomic
analysis of 4 FDA-cleared therapies (imiquimod, diclofenac, 5-fluorouacil [5-FU], and ALA PDT) for AK
given in combination with cryotherapy. This analysis assumes standard costs of procedures and office visits (based on April
2007 reimbursement data) and 2 treatment courses (medications: imiquimod, diclofenac, 5-FU) or sessions (ALA PDT)
of each modality followed by cryotherapy to 100% clearance. The total cost of each combination is $725.17 for ALA PDT,
$845.07 for diclofenac, $942.13 for 5-FU, and $1,473.39 for imiquimod. When phase III trial efficacies of the 4 modalities
are considered, the actual cost of using imiquimod or diclofenac increases because additional treatments may be required.
Among these 4 FDA-cleared therapies for multiple AK lesions, ALA PDT is the least expensive treatment and
imiquimod is the most expensive treatment under the stated assumptions.
Eugene H. Gans PhD, Iqbal Sadiq MS, Tracy Stoudemayer, Marianne Stoudemayer BS, Albert M. Kligman MD PhD
Purpose: Prolonged topical corticosteroid use is often associated with atrophic skin changes. This trial compared signs
of skin atrophy related to 3 super-high-potency corticosteroids: fluocinonide 0.1% cream, clobetasol propionate 0.05%
cream, and 0.05% foam.
Patients and Methods: The test treatments were applied to the forearms 10 females twice daily for 21 days. Skin characteristics
were assessed pretreatment and posttreatment for atrophic changes. Further punch biopsies obtained from 5
subjects were assessed histologically.
Results: Clobetasol foam produced mild changes in noninvasive tests, but stained skin biopsies revealed structural changes
nearly comparable to clobetasol cream, which showed substantial atrophic changes. Fluocinonide cream was the least
atrophogenic, producing no or only mild effects that were slightly greater than vehicle.
Conclusions: Fluocinonide cream has a lower potential to produce atrophic changes of the skin than either clobetasol
cream or clobetasol propionate foam.
Abbas Rasi MD, Leila Tajziehchi MD
Background: Despite the availability of various medical treatments for pityriasis rosea, a large percentage of patients fail
to achieve satisfactory results. Erythromycin is reported to be effective in the treatment of pityriasis rosea.
Methods:We designed a placebo-controlled study on 184 patients with pityriasis rosea attending the outpatient dermatology
department at Hazrat-e-Rasul Hospital in Tehran, Iran. Adult patients were treated with 200 mg of erythromycin
4 times daily and children were treated with 20 to 40 mg/kg daily in 4 divided doses. Controls were given a placebo (an
emollient cream) that was not identical in appearance. Subjects were seen at follow-up visits 2, 4, 6, and 8 weeks after
Results: Both groups were comparable with regard to sex, age, and mean duration of disease at the time of attending the
clinic. We found no significant difference between the 2 treatment groups at weeks 4, 6, and 8 after beginning of treatment.
Conclusion: In this study, prescription of oral erythromycin did not promote complete clearing of lesions.
Michael Romanowicz DMD RPh, Judith J Stephenson SM, James Q. Del Rosso DO, Greg Lenhart MS
Background: Rosacea is a chronic, relapsing dermatologic condition that affects an estimated 14 million people in the
US. However, there is little data in the literature on the healthcare utilization and costs of patients with rosacea in insured
Methods: This retrospective, observational, cohort study used the MarketScan databases to identify a rosacea cohort of
patients with medical and prescription drug claims between 2002 and 2005. Inclusion criteria were 1) age 30 years and
older, 2) at least one medical claim with a primary or secondary diagnosis of rosacea (ICD-9-CM 695.3), 3) at least one
pharmacy claim for a rosacea topical or systemic prescription drug, 4) a 6-month clean period prior to index drug and 12
months continuous enrollment after the index drug. Propensity score matching was used to match the rosacea cohort to
a control group of patients without rosacea. Disease severity during the 6-month preperiod was assessed by the Charlson
Comorbidity Index (CCI), the Chronic Disease Score (CDS), and the Elixhauser Index (EI). Healthcare utilization rates
and costs were determined by the type of care for the 12-month postperiod. Costs were calculated for the 12-month postperiod
and adjusted to reflect 2005 costs. Healthcare utilization rates and costs were reported for inpatient hospital
admissions, physician office visits, emergency room visits, other outpatient services, and outpatient pharmacy prescriptions.
Both total healthcare and rosacea-related rates and costs were reported.
Results: There were no rosacea-related inpatient admissions and very few emergency department visits. More rosacea
patients had a specialist visit than a primary care physician visit. The average number of rosacea-related prescriptions,
for all patients, was 3.4 (SD 2.7) per year. Total annual healthcare expenditures for the rosacea patient cohort were $735
more than for the matched controls ($6,458 vs. $5,723). Of the total healthcare costs, annual rosacea-related expenditures
were $276; approximately 70% of rosacea-related expenditures were due to prescription drugs. Topical drugs were
the index drugs for 77% of rosacea patients with branded metronidazole, which is the most common topical drug. Of the
23% of rosacea patients with an oral index drug, generic antibiotic dosage forms of tetracyclines were the most common
oral index drug therapy.
Conclusions: This is the first extensive study of rosacea and its impact on healthcare utilization and costs in an insured
population. Although rosacea is a common illness that does not have much financial impact on its sufferers, rosacea patients
incurred slightly higher direct total healthcare costs than matched controls.