P123

P125

Comparison of a novel solubilized benzoyl peroxide gel with benzoyl

peroxide/clindamycin: A multicenter, investigator-blinded, randomized
study
Emil Tanghetti, MD, Center for Dermatology and Laser Surgery, Sacramento, CA,
United States; David Wilson, MD, Education and Research Foundation,
Lynchburg, VA, United States; Sunil Dhawan, MD, Center for Dermatology,
Cosmetic and Laser Surgery, Fremont, CA, United States; Leon Kircik, MD,
Physicians Skin Care PLLC, Louisville, KY, United States

Tretinoin 0.05% formulated in a new gel vehicle: Evaluation of clinical

trial results in the treatment of acne vulgaris
James Del Rosso, DO, University of Nevada, Las Vegas, NV, United States

Introduction: A novel solubilized 5% benzoyl peroixide (BPO) gel has recently

become available as part of a 3-step system (involving solubilized BPO gel plus a 2%
salicylic acid-based cleanser and toner) to treat acne vulgaris. In other BPO
formulations, the bioavailability of BPO can be suboptimal, because BPO is poorly
soluble and exists as macrocrystals, which may inhibit its penetration into the
follicles. The patented technology used to develop the solubilized BPO gel offers
greater bioavailability of BPO in a vehicle that facilitates BPO penetration into
the follicles. We have compared this formulation with a leading combination
BPO/clindamycin prescription product in a multicenter, investigator-blinded study.
Methods: Patients were eligible for enrollment if they had moderate facial acne
vulgaris (25-100 comedos plus 25-100 inflammatory lesions) and were between 11
and 45 years of age. Patients were randomly assigned to apply the solubilized 5%
BPO gel to one side of their face and a 5% BPO/1% clindamycin combination product
to the other side of their face, twice daily for 4 weeks. Patients were evaluated in
terms of lesion counts and satisfaction with the improvement in their acne (rated as
very satisfied, satisfied, somewhat satisfied, indifferent, or dissatisfied). In addition,
erythema, dryness, peeling, burning/stinging, and itching were assessed (as none,
mild, moderate, or severe).

Tretinoin 0.05% in a novel aqueous gel formulated with hyaluronic acid, glycerin,
and trolamine has been evaluated in 2 double-blind, randomized, vehicle-controlled,
phase III pivotal 12-week trials (N 1537). One trial also included a comparison to
tretinoin 0.1% microsphere gel (n 376). Included were subjects [10 years of age
presenting with acne vulgaris of mild to moderate severity. Subjects were evaluated
at baseline and weeks 1, 2, 4, 8, and 12. Efficacy endpoints included nominal and
percent reduction in lesion counts (inflammatory, noninflammatory, and total
lesions) and dichotomized global severity assessment. Efficacy results were evaluated using both superiority and noninferiority testing and analyzed in both intent-totreat and per protocol populations. Local tolerability and safety were also assessed.
The results indicated that tretinoin 0.05% gel proved to be superior to vehicle gel in
absolute reduction from baseline in inflammatory lesion counts (P .0001) and
noninflammatory lesion counts (P \.0001), in percent reduction from baseline in
inflammatory lesion counts (P \.0001), and noninflammatory lesion counts (P \
.0001), and in dichotomized global severity assessments at week 12 (P .002). No
treatment-related serious adverse events were observed. In the comparative
evaluation of active treatment arms, tretinoin 0.05% gel was not inferior to tretinoin
0.1% microsphere gel and demonstrated a more favorable tolerability profile with
fewer signs and symptoms of skin irritation.
100% of poster production sponsored by Coria Laboratories.

Results: A total of 23 patients were enrolled. At day 28, the solubilized BPO gel
resulted in relatively greater reductions in both the noninflammatory lesion count
(40% with solubilized BPO gel vs. 28% with BPO/clindamycin) and the inflammatory
lesion count (68% vs. 59%, respectively). Patient satisfaction with acne improvement
was comparable in both groups. Mean levels of erythema, dryness, peeling,
burning/stinging, and itching were less than mild in both groups at all timepoints.
Conclusions: Twice-daily monotherapy with the solubilized 5% BPO gel for 28 days
offers greater reductions in acne lesion counts and comparable patient satisfaction
relative to a combination BPO/clindamycin prescription product. The early reduction in lesion counts observed with the solubilized BPO gel in the absence of an
antibiotic is potentially of considerable clinical importance. Further research will
help confirm these findings and evaluate the benefits of longer-term treatment.
Supported by OMP, Inc.

P126

P124
Subsets of patients that experience greater benefit with adapalene 0.3%
treatment for acne vulgaris
Michael Graeber, MD, Galderma Research and Development, Cranbury, NJ,
United States; Yin Liu, PhD, Galderma Research and Development, Cranbury, NJ,
United States
Acne vulgaris is difficult to treat, and poor results are often psychologically
detrimental to affected individuals. These difficulties propel continual research
into better treatment approaches. A multicenter, vehicle-controlled, randomized
study comparing adapalene 0.3% gel to adapalene 0.1% gel and gel vehicle was
conducted in acne patients aged 12 to 52 years. A total of 584 patients were enrolled,
randomized, and completed 12 weeks of treatment with one of the treatments
described above. Evaluations were made at baseline, weeks 1, 2, 4, 8, and 12.
Success was defined as a rating of clear or almost clear on the Investigators Global
Assessment. Subgroup analyses by gender, clinical assessment of skin oiliness, and
baseline lesion counts were conducted to determine if those patients might realize
greater benefit than the general population of acne patients from a higher
concentration of adapalene. Among male patients, 50% more achieved treatment
success with adapalene 0.3% gel than with adapalene 0.1% gel. More than twice as
many adapalene 0.3% geletreated patients (21%) with oily skin achieved success
than did adapalene 0.1% geletreated patients with oily skin (10%). Finally, patients
with greater baseline lesion counts ([25 inflammatory lesions and [35 noninflammatory lesions) experienced a 31% higher success rate with adapalene 0.3% gel than
with adapalene 0.1% gel. Local cutaneous irritation described as erythema, scaling,
dryness, and burning/stinging was captured for all reports of irritation worse than at
baseline. The majority of reports for each type of irritation were mild in severity for
adapalene 0.3% geletreated patients. Adverse events related to treatment with
adapalene 0.3% gel included dry skin (14%), skin discomfort (5.8%), pruritus (1.9%),
and sunburn (1.2%). These results support the coexistence of both concentrations
of adapalene and show that some subpopulations may benefit more from treatment
with adapalene 0.3% gel than with adapalene 0.1% gel, while other subpopulations
derive similar benefit from the two concentrations.
Study and poster support provided by Galderma Laboratories, L.P.

FEBRUARY 2008

Treatment of acne vulgaris by photodynamic therapy with aminolevulinic

acid: Clinical and histopathologic findings
Eun Ju Hwang, MD, S&U Clinic, Seoul, South Korea; Seung Ho Chang, MD, S&U
Clinic, Seoul, South Korea; Bang Soon Kim, MD, S&U Clinic, Seoul, South Korea;
Mi Kyung Cho, MD, S&U Clinic, Seoul, South Korea
Background: Photodynamic therapy (PDT) involves the application of a photosensitizer which, when exposed to wavelengths of light absorbed by the photosensitizer, results in excitation of photosensitizer and production of cytotoxic reactive
oxygen species. Although PDT with aminolevulinic acid (ALA) is widely used to treat
acne, data showing long-term results and methods to treat comedonal acne have not
been reported.
Objectives: This study was designed to determine the long-term effects of ALA-PDT
for the treatment of acne vulgaris and to present histopathologic evidence for the
destruction of sebaceous glands by ALA-PDT.
Methods: More than 200 patients with moderate to severe facial acne were treated
by ALA-PDT in my clinic during 2005 to 2007. An intense pulsed light (IPL) device
with a 550- and 600-nm cutoff filter or photopneumatic therapy (PPX) device with
400- to 1200-nm wavelength were used as light source. ALA was applied to the entire
face and allowed to incubate for 2 hours. After removal of ALA, the entire face was
irradiated with IPL or PPX. The short- and long-term effects of the single treatment
were evaluated by clinical examinations and light microscopy. Apoptotic effects
were observed with use of hematoxylineeosin staining and TUNEL staining.
Results: Inflammatory acne lesions responded rapidly to ALA-PDT. In patients
followed for up to 2 years, inflammatory lesions of 87% of patients were completely
or nearly completely cleared. Noninflammatory lesions also showed good response.
Noninflammatory lesions of 78% of patients were completely or nearly completely
cleared up to 2 years after ALA-PDT. Side effects included erythema, exfoliation, and
transient hyperpigmentation with no sequelae of therapy. As shown by hematoxylineeosin and TUNEL staining, sebaceous glands could be easily destroyed with the
usual standard protocol of ALA-PDT. Especially, a several additional method to treat
comedonal lesions effectively is needed.
Conclusion: This study showed that ALA-PDT provided excellent long-term efficacy
for the treatment of facial acne. The histopathologic data show that ALA-PDT
selectively destroys sebaceous glands.
Commercial support: None identified.

J AM ACAD DERMATOL

AB17