P7755
Clinical evaluation of the skin lightening benefits of a formulation
containing hydroxyphenoxy propionic acid, ellagic acid, yeast extract,
and salicylic acid in subjects with moderate hyperpigmentation and dark
spots
Margarita Yatskayer, L’Oreal Research & Innovation, Clark, NJ, United States;
Amanda Dahl, L’Oreal Research & Innovation, Clark, NJ, United States; Christian
Oresajo, L’Oreal Research & Innovation, Clark, NJ, United States; Nannan Chen,
L’Oreal Research & Innovation, Clark, NJ, United States; Yevgeniy Krol,
Skinceuticals Inc, New York, NY, United States
Hyperpigmentation and uneven skin tone common concerns found in all skin types.
A variety of treatments are available to treat hyperpigmentation, with the criterion
standard being prescription topical skin lightening agents. Safety concerns
surrounding prescription treatments in recent years has led to an increase in the
need for over the counter skin lightning cosmetics. This 12-week clinical study
evaluated the skin lightening benefits and tolerability of a new cosmetic formulation
applied twice daily containing hydroxyphenoxy propionic acid, ellagic acid, yeast
extract, and salicylic acid in subjects with moderate levels of hyperpigmentation and
dark spots. The multiethnic panel included 114 subjects (28% African American,
16% Asian, 31% white, and 25% Hispanic). Evaluations included objective and
subjective tolerance grading, clinical grading of facial skin attributes for dark spots,
hyperpigmentation, PIH, skin tone evenness and clarity, firmness, elasticity, fine
lines and wrinkles, skin texture, radiance, appearance of facial imperfections, and
overall facial appearance. Subject self-assessment questionnaires, noninvasive
bioinstrumentation to assess skin hydration, skin caliper, and digital photography
were also included in the study. The results of this study showed statistically
significant improvements compared to baseline as early as week 4 for pigmentation
attributes as well as the antiaging attributes including hyperpigmentation, dark
spots, PIH, skin tone evenness, radiance, firmness and elasticity. All remaining
attributes showed significant improvements after 8 weeks. Tolerance assessments
indicated that the product was well tolerated by all subjects throughout the 12-week
study duration. The questionnaire responses from the subjects indicated that the
subjects perceived improvement in the appearance of their skin as early as 4 weeks
and the product performed favorably.
Sponsored 100% by L’Oreal.
P7914
Comparison of efficacy and safety of 0.1%tacrolimus ointment and 0.1%
mometasone furoate cream for adult vilitigo: A single-blind pilot study
Sunatra Nitayavardhana, Department of Dermatology, Faculty of Medicine Siriraj
Hospital, Bangkok, Thailand; Chanisada Wongpraparut, Department of
Dermatology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand;
Kanchalitt Thanomkitti, Department of Dermatology, Faculty of Medicine
Siriraj Hospital, Bangkok, Thailand; Narumol Silpa-archa, Department of
Dermatology,Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
Background: Vitiligo remains a difficult disease to treat. It usually takes several
months or years for complete repigmentation. Topical corticosteroids are still the
standard treatment of localized vitiligo. However, the adverse effects are commonly
found such as skin atrophy, striae, pigmentary change. Tacrolimus is a new
immunosuppressive agent. Nowadays, it demonstrates efficacies in many skin
conditions including vitiligo.
Objective: To compare the efficacy and safety of 0.1% tacrolimus ointment with 0.1%
mometasone furoate cream in the treatment of adult vitiligo.
Methods: Twenty subjects with symmetrical, nonacral vitiligo were enrolled into
this study. The vitiligo patches in each side of the body were randomized to recieve
0.1% mometasone furoate cream or 0.1% topical tacrolimus ointment. The
medications were applied twice daily for 6 months. All subjects were followed up
for clinical response and adverse effects every 2 months. Clinical assessments were
evaluated by percent of repigmentation at 6 months compared with baseline.
Grading of repigmentation was classified in to 4 groups as no improvement, 0-25%,
26-50%, 51-75%, and 76-100% of repigmentation.
Results: Eighteen subjects completed the study. Most of the subjects in both groups
got improvement at 1-25% repigmentation (50% in 0.1% tacrolimus group and 34%
in 0.1% mometasone furoate group). At the end of the study, there was no statistical
significant difference in repigmentation in both groups. The only adverse event was
telangiectasia, which was found in 6 cases of 0.1% momethasone furoateetreated
side (P ¼ .03).
Conclusion: 0.1% Tacrolimus ointment and 0.1%mometasone furoate cream are
effective in treatment of vitiligo; however, 0.1% tacrolimus ointment provides a less
adverse effect.
Commercial support: None identified.
MAY 2014
P8718
Developing a questionnaire to evaluate the burden of vitiligo
Khaled Ezzedine, MD, St. Andre Hospital, Bordeaux, France; Alain Taieb, MD, St.
Andre HospitaL, Bordaux, France; Charles Taieb, MD, PFSA, Paris, France
Introduction: Vitiligo (V) affects nearly 0.5% of the population, and is the primary
cause of skin depigmentation. Because it is not life-threatening, V is considered by
some health care professionals to be an esthetic or cosmetic condition. However,
there is a consensus regarding the fact that treating patients involves allowing them
to express their difficulties and taking their complaints into account.
Objective: The aim of this study is to create a Q that will facilitate the evaluation of
this burden.
Patients and methods: The questionnaire (Q) is developed in 3 phases. Each of these
phases followed its own strict methodologic process, involving a multidiscipline
team combining players from dermatology, patients’ associations, and experts
in ‘‘PRO.’’ These parties all play a part in patient management or are experts in
creating Q.
Results: Exploration phase: a literature review revealed that the methods used to
assess V are generally not specific to the condition and give very heterogeneous
results, which served to confirm the necessity for this Q. During the course of
semistructured interviews and discussions, it became clear that it would be relevant
to include phototype as a parameter in the Q. Following qualitative interviews, the
primary effects reported by patients were: feeling discouraged by the condition,
modifications to physical appearance, discrimination at work, difficulty initiating
intimate relationships, a general feeling of unease, and financial difficulties. At this
stage, 56 items were generated and then reorganized according to their structure,
forming 41 Q. Development phase: possible responses to the Q were created in the
classic method allowing for easy calibration of responses. A preliminary evaluation
helped to limit redundant items and group Q according to type. Q that did not give
clear answers were also removed. The pilot version of the Q was comprised of 25 Q,
which made it suitable for use in large-scale longitudinal studies. Finally, each
question was subject to cognitive debriefing for patients’ ease of comprehension
and acceptability, carried out by a specialist organization. This stage resulted in no
major modifications to the wording of the Q.
Conclusion: In order for the Q to be used in studies, it needs to undergo
psychometric validation (internal and external). Factorial analysis is also needed
to establish the underlying features that the Q is intended to measure, and identify
items that are very or too correlated with them.
Commercial support: None identified.
P7840
Efficacy and safety of combined low-fluence Q-switched Nd:YAG 1,064-nm
laser with intensed pulsed light versus low-fluence Q-switched Nd:YAG
1,064-nm laser monotherapy in the treatment of melasma
Punyaphat Sirithanabadeekul, MD, Division of Dermatology, Ramathibodi
Hospital, Mahidol University, Bangkok, Thailand; Vasanop Vachiramon, MD,
Division of Dermatology, Ramathibodi Hospital, Mahidol University, Bangkok,
Thailand
Background: Low-fluence Q-switched Nd:YAG 1,064-nm laser (LFQS) and intense
pulsed light (IPL) have been shown to be effective in the treatment of melasma.
LFQS can target deeper pigment, while IPL can target a wide range of cutaneous
structures, including epidermal pigment and vasculature. However, there is limited
information on efficacy and side effects of the combined treatment.
Methods: Twenty female patients with mixed-type melasma were enrolled in the
prospective, randomized, single-blind, split face study. Both sides of the face
received a series of 5 LFQS treatments at 1-week intervals. One side of the face was
randomly assigned to receive additional 3 sessions of IPL treatments at 2-week
intervals. Patients were evaluated 12 weeks after the last treatment. Outcome
measures include the assessment by colorimeter using relative lightness index,
modified Melasma Area and Severity Index (mMASI), patient satisfaction (visual
analog scale), and adverse effects.
Results: Both groups were shown significant improvement of relative lightness
index and mMASI score. The significant improvement was favor on combined side
which showed better result since the second week while monotherapy side showed
statistical significant on the third week. At the end of laser treatment, 55%
improvement and 37% improvement was observed on combined side and
monotherapy side, respectively. More than 70% of patient on combined side and
56% on monotherapy side rated their clinical improvement as excellent or good.
Recurrence was occurred 33% and 11% on combined side and monotherapy side
respectively. No serious side effect was noted.
Conclusion : The combination of LFQS and IPL more rapidly produce significant
clinical outcome resulting in decrease number of LFQS exposure. However,
recurrence is still inevitable.
Commercial support: None identified.
J AM ACAD DERMATOL AB159