P8064
Tolerability and performance of a moisturizer with SPF 30 in acne subjects
undergoing treatment
Raymond L. Garcia, MD, RCTS, Inc, Irving, TX, United States; Michael Graeber,
MD, Galderma Research & Development, Inc, Cranbury, NJ, United States
A 4-week, single center study (N 93) was conducted to determine the cutaneous
tolerability and performance of a moisturizer with SPF 30 (Galderma Laboratories,
L.P., Ft. Worth, TX) when used in acne patients, who were on acne treatments.
Subjects, aged 13-45 years, were instructed to apply the moisturizer once daily in the
morning while continuing their existing acne treatment. Cutaneous tolerability was
evaluated through changes in dermatologic signs (erythema, edema, dryness,
roughness and oozing on the face) and querying for symptoms (burning, tightness,
itching and stinging). Performance of the moisturizer on skin hydration was further
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
(improvement), relative to baseline, in erythema values was observed after 7 days of
moisturizer use (P .021). Significant decreases (improvement), relative to baseline,
in dryness values and in roughness values were also observed after 7, 14, and 28 days
of moisturizer use (P \.05). There was a significant increase in skin conductance
relative to baseline (observed on day 7 and lasting until day 28) indicating an
increase in skin moisturization. Tolerability was good with no significant changes,
relative to baseline, in the degree of burning, itching, stinging or tightness. Adverse
events reported by 21.5% of subjects were skin reactions which were deemed
related to the study products. All adverse events except for one were mild in severity
and most of them were transient, lasting a few seconds to a few hours. One reaction
was moderate in severity and led to study discontinuation (rash on the face). Overall,
once daily application of a moisturizer with SPF 30 was well tolerated and
significantly improved skin hydration of acne patients under treatment.
Supported by Galderma R&D, SNC. Poster/editorial support provided by
Galderma Laboratories, L.P.
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,
tretinoin is poorly soluble, can be a teratogen at high plasma concentrations, and is
associated with skin irritation. A novel delivery technology comprised of different
forms of phosphorylated vitamin E, TPM, has been shown to have both antiirritant
and antiacne properties, as well as increasing the dermal delivery of poorly soluble
compounds into the skin after topical application. A series of human trials were
conducted to investigate whether TPM could increase the dermal absorption of
tretinoin without increasing systemic exposure, and to also examine the irritation
produced by these formulations. A phase I human trial used sequential tape
stripping in 12 subjects to investigate the dermal penetration of tretinoin in humans
following a single topical application of the commercial Retin-A cream (Janssen-
Cilag, Australia) versus a TPM/tretinoin formulation. Blood was collected to measure
the plasma concentration of tretinoin. Topical application of TPM/tretinoin
significantly increased the average amount of tretinoin delivered into the upper
layers of the strata corneum (3.75-fold) when compared with the Retin-A
formulation. Despite the increased absorption, no tretinoin was detected in any
plasma samples above the limit of quantitation (4.66 ng/ml). A repeat insult patch
test (RIPT) was conducted in 27 subjects to compare the irritation produced by
TPM/tretinoin formulation versus Retin-A. Each test product was applied to the back
of each subject on a semi-occlusive patch every other day for the first week (Days 1
and 3), daily during the 2nd week (Days 8-11) and daily during the 3rd week (Days
15-18). The test materials were applied to the same site for each application. Patches
were worn for 24 hours and removed, before being assessed for irritation. Average
scores of erythema for TPM/tretinoin after 19 days of application were none-to-very
mild. By contrast, average erythema scores between mild-to-moderate were
generated by topical application of the commercial Retin-A cream. The differences
in erythema between formulations become significant (P \ .05) after 15 days of
application. A TPM/tretinoin formulation was able to increase the delivery of
tretinoin while reducing the irritation when compared to a leading comparator
product. TPM formulations are now being assessed in phase II clinical trials to assess
their potential to treat acne.
Supported 100% by Phosphagenics Ltd.
MAY 2014
P8343
Treatment failure of patients using topical acne treatments: An observa-
tional retrospective cohort study
S. Evan Carstensen, Wake Forest School of Medicine, Winston-Salem, NC, United
States; Karen Huang, MS, Wake Forest School of Medicine, Winston-Salem, NC,
United States; Steven Feldman, MD, PhD, Wake Forest School of Medicine,
Winston-Salem, NC, United States
Background: While limited data from clinical trials show differences in efficacy
between topical acne combination products and monotherapies, the effect of these
differences in clinical practice is not explored.
Purpose: To evaluate the effectiveness in clinical practice of prescribing combina-
tion treatments compared to monotherapy product(s) in minimizing treatment
failures.
Methods: Patients diagnosed with acne (ICD-9: 706.1) by a dermatologist between
January 2009 and September 2011and initially prescribed a topical acne treatment
were extracted from the Wake Forest School of Medicines Transitional Data
Warehouse. Multivariate Cox proportional hazards models were employed to
compare the hazards of treatment failure for patients initially prescribed a combi-
nation product vs. one monotherapy or multiple monotherapies. Subgroup analyses
were performed for specific drug combination products.
Results: 335 patients were initially prescribed topical product(s) exclusively. After
adjusting for patient age, sex, race and ethnicity, there was no evidence in differing
hazards of treatment failure for those prescribed a combination product compared
to those either prescribed one monotherapy product (HR 0.91, P .65) or
prescribed multiple monotherapy products (HR 0.73, P .17). Those prescribed a
retinoid/benzoyl peroxide product had a nonsignificant lower hazard of 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).
Limitations: Disease severity and treatments prescribed outside of the hospital
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
grant from Galderma Laboratories, L.P.
P8333
Treatment patterns and costs associated with acne in the United States
James D. Kendall, PharmD, Galderma Laboratories, L.P., Fort Worth, TX, United
States; Norman J. Preston, PhD, Galderma Laboratories, L.P., Fort Worth, TX,
United States
Acne vulgaris is a chronic skin disease affecting up to 87% of adolescents and over
50% of adults at some point in their lives. The monetary costs associated with acne
are high; over $2.2 billion was directly spent on acne OTC products, prescription
drugs, and office visits in the US in 2004. Despite the high prevalence and monetary
costs, there is a lack of published literature describing current treatment patterns
and comparative effectiveness assessments of prescription acne drugs. A retrospec-
tive study, using the IMS LifeLInk Health Plan Claims Database, was conducted to
provide a description of current prescription drug patterns and healthcare utiliza-
tion in acne. The study period was from January 1, 2009 to June 30, 2011. A total of
66,249 patients met the complete inclusion criteria and were included for study.
Most patients were female (58.3%) with a mean age of 17.9 years. Seventy-three
percent were on monotherapy which included combination products, topical
retinoids, oral antibiotics, or oral isotretinoin. An average of 60% of patients
prescribed a topical medication only had 1 prescription filled. The medical
possession ratio was 80.6% for oral isotretinoin compared to 27.8% for combination
topicals, 31.3% for topical retinoids, and 44.6% for oral antibiotics. Acne related
costs were highest for oral isotretinoin ($380 for medical; $2,439 for pharmacy).
Dermatologists were more likely to prescribe oral isotretinoin, oral antibiotics, and
combination therapy. Medical costs, pharmacy costs, and the number of physician
visits were also higher for dermatologists compared to nondermatologists. The
results of this study demonstrate that the prescribing patterns, medical costs, and
number of physician visits is different between dermatologists and nondermatolo-
gists. This is not surprising as dermatologists tend to be referred more complex and
treatment resistant patients.
Study funded and poster/editorial support provided by Galderma Laboratories,
L.P.
J AM ACAD DERMATOL AB11