P8064 P8343

Tolerability and performance of a moisturizer with SPF 30 in acne subjects Treatment failure of patients using topical acne treatments: An observa-
undergoing treatment tional retrospective cohort study
Raymond L. Garcia, MD, RCTS, Inc, Irving, TX, United States; Michael Graeber, S. Evan Carstensen, Wake Forest School of Medicine, Winston-Salem, NC, United
MD, Galderma Research & Development, Inc, Cranbury, NJ, United States States; Karen Huang, MS, Wake Forest School of Medicine, Winston-Salem, NC,
A 4-week, single center study (N 93) was conducted to determine the cutaneous United States; Steven Feldman, MD, PhD, Wake Forest School of Medicine,
tolerability and performance of a moisturizer with SPF 30 (Galderma Laboratories, Winston-Salem, NC, United States
L.P., Ft. Worth, TX) when used in acne patients, who were on acne treatments. Background: While limited data from clinical trials show differences in efficacy
Subjects, aged 13-45 years, were instructed to apply the moisturizer once daily in the between topical acne combination products and monotherapies, the effect of these
morning while continuing their existing acne treatment. Cutaneous tolerability was differences in clinical practice is not explored.
evaluated through changes in dermatologic signs (erythema, edema, dryness, Purpose: To evaluate the effectiveness in clinical practice of prescribing combina-
roughness and oozing on the face) and querying for symptoms (burning, tightness, tion treatments compared to monotherapy product(s) in minimizing treatment
itching and stinging). Performance of the moisturizer on skin hydration was further failures.
assessed on a subset of the population (n 30) by evaluating skin conductance at
day 7, day 14, and day 28 relative to baseline. Overall a significant decrease Methods: Patients diagnosed with acne (ICD-9: 706.1) by a dermatologist between
(improvement), relative to baseline, in erythema values was observed after 7 days of January 2009 and September 2011and initially prescribed a topical acne treatment
moisturizer use (P .021). Significant decreases (improvement), relative to baseline, were extracted from the Wake Forest School of Medicines Transitional Data
in dryness values and in roughness values were also observed after 7, 14, and 28 days Warehouse. Multivariate Cox proportional hazards models were employed to
of moisturizer use (P \.05). There was a significant increase in skin conductance compare the hazards of treatment failure for patients initially prescribed a combi-
relative to baseline (observed on day 7 and lasting until day 28) indicating an nation product vs. one monotherapy or multiple monotherapies. Subgroup analyses
increase in skin moisturization. Tolerability was good with no significant changes, were performed for specific drug combination products.
relative to baseline, in the degree of burning, itching, stinging or tightness. Adverse Results: 335 patients were initially prescribed topical product(s) exclusively. After
events reported by 21.5% of subjects were skin reactions which were deemed adjusting for patient age, sex, race and ethnicity, there was no evidence in differing
related to the study products. All adverse events except for one were mild in severity hazards of treatment failure for those prescribed a combination product compared
and most of them were transient, lasting a few seconds to a few hours. One reaction to those either prescribed one monotherapy product (HR 0.91, P .65) or
was moderate in severity and led to study discontinuation (rash on the face). Overall, prescribed multiple monotherapy products (HR 0.73, P .17). Those prescribed a
once daily application of a moisturizer with SPF 30 was well tolerated and retinoid/benzoyl peroxide product had a nonsignificant lower hazard of treatment
significantly improved skin hydration of acne patients under treatment. failure (HR 0.85, P .61); whereas clindamycin/benzoyl peroxide had a non-
significant higher hazard of treatment failure (HR 1.29, P .33).
Supported by Galderma R&D, SNC. Poster/editorial support provided by
Limitations: Disease severity and treatments prescribed outside of the hospital
Galderma Laboratories, L.P.
system were not available.
Conclusions: Treatment failures were consistent for patients prescribed combina-
tion product(s) or monotherapies. Patients prescribed combination retinoid/ben-
zoyl peroxide products may have a lower hazard of treatment failure, but larger
studies are needed to confirm this effect.

The Center for Dermatology Research is supported by an unrestricted educational

P8472
TPM/tretinoin formulations increase dermal tretinoin absorption and
reduce irritation compared to a commercial comparator formulation
Paul Gavin, PhD, Phosphagenics Ltd, Clayton, Australia; Biljana Nikolovski, PhD,
Phosphagenics Ltd, Clayton, Australia; Giacinto Gaetano, Phosphagenics Ltd,
Clayton, Australia; Mahmoud El-Tamimy, PhD, Phosphagenics Ltd, Clayton,
Australia; Ranelle Anderson, Phosphagenics Ltd, Clayton, Australia
Tretinoin is a leading prescription drug for the treatment of acne vulgaris. However, P8333
tretinoin is poorly soluble, can be a teratogen at high plasma concentrations, and is Treatment patterns and costs associated with acne in the United States
associated with skin irritation. A novel delivery technology comprised of different
forms of phosphorylated vitamin E, TPM, has been shown to have both antiirritant James D. Kendall, PharmD, Galderma Laboratories, L.P., Fort Worth, TX, United
and antiacne properties, as well as increasing the dermal delivery of poorly soluble States; Norman J. Preston, PhD, Galderma Laboratories, L.P., Fort Worth, TX,
compounds into the skin after topical application. A series of human trials were United States
conducted to investigate whether TPM could increase the dermal absorption of Acne vulgaris is a chronic skin disease affecting up to 87% of adolescents and over
tretinoin without increasing systemic exposure, and to also examine the irritation 50% of adults at some point in their lives. The monetary costs associated with acne
produced by these formulations. A phase I human trial used sequential tape are high; over $2.2 billion was directly spent on acne OTC products, prescription
stripping in 12 subjects to investigate the dermal penetration of tretinoin in humans drugs, and office visits in the US in 2004. Despite the high prevalence and monetary
following a single topical application of the commercial Retin-A cream (Janssen- costs, there is a lack of published literature describing current treatment patterns
Cilag, Australia) versus a TPM/tretinoin formulation. Blood was collected to measure and comparative effectiveness assessments of prescription acne drugs. A retrospec-
the plasma concentration of tretinoin. Topical application of TPM/tretinoin tive study, using the IMS LifeLInk Health Plan Claims Database, was conducted to
significantly increased the average amount of tretinoin delivered into the upper provide a description of current prescription drug patterns and healthcare utiliza-
layers of the strata corneum (3.75-fold) when compared with the Retin-A tion in acne. The study period was from January 1, 2009 to June 30, 2011. A total of
formulation. Despite the increased absorption, no tretinoin was detected in any 66,249 patients met the complete inclusion criteria and were included for study.
plasma samples above the limit of quantitation (4.66 ng/ml). A repeat insult patch Most patients were female (58.3%) with a mean age of 17.9 years. Seventy-three
test (RIPT) was conducted in 27 subjects to compare the irritation produced by percent were on monotherapy which included combination products, topical
TPM/tretinoin formulation versus Retin-A. Each test product was applied to the back retinoids, oral antibiotics, or oral isotretinoin. An average of 60% of patients
of each subject on a semi-occlusive patch every other day for the first week (Days 1 prescribed a topical medication only had 1 prescription filled. The medical
and 3), daily during the 2nd week (Days 8-11) and daily during the 3rd week (Days possession ratio was 80.6% for oral isotretinoin compared to 27.8% for combination
15-18). The test materials were applied to the same site for each application. Patches topicals, 31.3% for topical retinoids, and 44.6% for oral antibiotics. Acne related
were worn for 24 hours and removed, before being assessed for irritation. Average costs were highest for oral isotretinoin ($380 for medical; $2,439 for pharmacy).
scores of erythema for TPM/tretinoin after 19 days of application were none-to-very Dermatologists were more likely to prescribe oral isotretinoin, oral antibiotics, and
mild. By contrast, average erythema scores between mild-to-moderate were combination therapy. Medical costs, pharmacy costs, and the number of physician
generated by topical application of the commercial Retin-A cream. The differences visits were also higher for dermatologists compared to nondermatologists. The
in erythema between formulations become significant (P \ .05) after 15 days of results of this study demonstrate that the prescribing patterns, medical costs, and
application. A TPM/tretinoin formulation was able to increase the delivery of number of physician visits is different between dermatologists and nondermatolo-
tretinoin while reducing the irritation when compared to a leading comparator gists. This is not surprising as dermatologists tend to be referred more complex and
product. TPM formulations are now being assessed in phase II clinical trials to assess treatment resistant patients.
their potential to treat acne.
Study funded and poster/editorial support provided by Galderma Laboratories,
Supported 100% by Phosphagenics Ltd. L.P.

MAY 2014 J AM ACAD DERMATOL AB11