Safety and Efficacy of Two Anti-Acne/Anti-Aging Treatments in Subjects With Photodamaged Skin and Mild to Moderate Acne Vulgaris
June 2012 | Volume 11 | Issue 6 | Original Article | 737 | Copyright © June 2012
Leon H. Kircik MD,a,b Amanda Dahl BS,c Margarita Yatskayer MS,c Susana Raab BS,c Christian Oresajo PhDc
aPhysicians Skin Care, PLLC, Louisville, KY; Mount Sinai Medical Center, New York, NY;and Indiana University School of Medicine, Indianapolis, IN cL'Oreal USA Research and Innovation, Clark, NJ
Abstract
Background: Although reliable prevalence data are not available, adult acne is thought to be somewhat common, and it is not unusual for patients
to have acne as well as early signs of skin aging. A novel anti-acne/anti-aging formulation (Treatment A) has been developed for daily use by
patients to address both signs of skin aging and facial acne vulgaris. The novel, non-prescription formulation includes several ingredients shown
to target factors underlying the pathogenesis of acne vulgaris while also addressing multiple components in the pathophysiology of skin aging.
Methods: A blinded, randomized, split-face study was conducted to evaluate and compare the tolerability and efficacy of the novel anti-acne/
anti-aging product in subjects with photodamaged skin and acne vulgaris relative to tretinoin cream 0.025% (Treatment B). All subjects also
were given supportive skincare, consisting of a cleanser, moisturizer, and sunscreen. Each treatment was assessed for its effects on subjects'
appearance, lesion count reductions, and tolerability.
Results: Treatment A produced statistically significantly greater improvements in skin tone evenness, skin tone clarity, and blemishes
and blotchiness. There were also statistically greater reductions in total lesion count for acne patients on the side of the face treated with
Treatment A compared to Treatment B; Treatment A was also associated with early (day 2) improvement in skin tone evenness and clarity,
tactile skin smoothness, and blemishes and blotchiness. Both treatments demonstrated favorable tolerability.
Conclusion: The novel topical anti-aging/anti-acne therapy (Treatment A) within a comprehensive skin care regimen of cleanser, moisturizer, and
sunscreen may maximize efficacy and tolerability and contribute to our armamentarium for treating both photodamage and acne at the same time.
J Drugs Dermatol. 2012;11(6):737-740
INTRODUCTION
The prevalence of adult acne is not well established, although
it is now recognized that many patients develop
acne or have persistent acne well beyond adolescence
into adulthood. It is not unusual, therefore, for patients to have
acne as well as early signs of skin aging.
Tretinoin is a standard topical anti-aging therapy, and it is one of
the most widely used topical prescription acne therapies.1 More
than 70% of retinoid prescriptions are for patients with acne.2
However, topical tretinoin can be associated with poor tolerability
and significant cutaneous irritation. Alternative management
options that yield similar efficacy with increased tolerability are
therefore desired, though they have been difficult to develop.
A novel anti-acne/anti-aging formulation (Fla. 855061 5, L'Oreal, Clark,
NJ) has been developed for daily use to address signs and symptoms
of both skin aging and facial acne vulgaris. The non-prescription
topical formulation includes several ingredients shown to target
factors underlying the pathogenesis of acne vulgaris while also addressing
multiple components in the pathophysiology of skin aging.
For example, dioic acid 2% is a naturally derived botanical ingredient
shown to reduce surface sebum and reduce P. acnes proliferation. It also stimulates peroxisome proliferator-activated receptors (PPARs)
and may prevent hyperpigmentation. Salicylic capryloyl acid, with a
lipid structure similar to that of human skin, confers anti-bacterial and
anti-inflammatory effects. It is thought to encourage exfoliation of
keratinocytes. The lipid soluble beta-hydroxy acid salicylic acid 1.5%
accelerates desquamation and offers anti-comedogenic effects. The
formulation also contains HEPES (hydroxyethylpiperazineethanosulfonic
acid), an aminosulfonic derivative that stimulates protease
activity in the stratum corneum leading to degradation of corneodesmosine
and therefore eventual desquamation.
A blinded, randomized, split-face study was conducted to
evaluate and compare the tolerability and efficacy of the novel
anti-acne/anti-aging product in subjects with photodamaged
skin and acne vulgaris relative to tretinoin cream 0.025%. All
subjects also were given supportive skincare, consisting of a
cleanser, moisturizer, and sunscreen.
Patient Recruitment and Inclusion Criteria
Males and females of all skin types and ethnicities from 35 to 55
years of age, in good general health, were eligible for enrollment.
Primary inclusion criteria included the presence of clinically deter-