An Evaluation of the Benefits of a Topical Treatment in the Improvement of Photodamaged Hands With Age Spots, Freckles, and/or Discolorations
December 2013 | Volume 12 | Issue 12 | Original Article | 1468 | Copyright © December 2013
Michael H. Gold MDa,b and Conor Gallagher PhDc
aTennessee Clinical Research Center, Nashville, TN
bGold Skin Care Center, Nashville, TN
cAllergan, Inc., Irvine, CA
Abstract
BACKGROUND: Photoaging of the hands is common due to frequent exposure to environmental factors.
OBJECTIVE: To evaluate the efficacy of a topically applied cream formulated with an alpha-hydroxy acid, depigmenting agents, and antioxidants
to improve the appearance of characteristics associated with photodamaged hands.
METHODS: This was a single-site, open-label study of a proprietary topical treatment (Vivité Vibrance Décolleté, Allergan, Inc.) in adult
female subjects with moderate-to-severe photoaging of the hands. The treatment was administered to the hands twice daily over an
8-week period. Treatment efficacy was assessed at baseline and weeks 4 and 8 using the Investigator Global Assessment (IGA) score
based on the percentage coverage and color depth of photodamaged areas. The severity of age spots, freckles, and hand skin discoloration
were also assessed; digital and ultraviolet photography of the hands was performed. Subject-reported assessments of treatment
efficacy were evaluated using a questionnaire administered at week 8. Statistical significance was defined with an α set at P≤.05.
RESULTS: Thirty-five subjects were enrolled with a mean age of 55.6 years; 33 subjects completed the study. The IGA of the appearance
of hand photodamage improved from a mean (standard deviation) score of 5.0 (0.8) at baseline to 3.1 (1.5) and 2.6 (1.3) at weeks 4 and
8, respectively (1=mild; 9=severe). Based on expert-grader evaluation, subjects demonstrated statistically significant improvements
from baseline in IGA at weeks 4 and 8 in age spots and freckling at weeks 4 and 8, (P<.0003) and in skin discolorations at week 8
(P<.05). The majority of subjects reported that they perceived improvements in each of the 9 parameters associated with skin appearance.
No adverse events were reported.
CONCLUSIONS: The appearance of age-related hand pigmentation characteristics were significantly improved at 4 and 8 weeks of treatment.
Subjects reported post-treatment improvements in other characteristics associated with healthy skin.
J Drugs Dermatol. 2013;12(12):1468-1472.
INTRODUCTION
Photodamage is one of the major causes of premature aging
of the skin.1 The hands receive extensive exposure to
environmental factors as well as to different agents that
may promote skin damage. In addition, deterioration in collagen
and elastin, and reduced tissue volume is associated with the skin
of the aging hand.1-5 Therefore, skin damage due to sun exposure
is superimposed on the chronological aging process,1,6 and the
hands are often the first part of the body to show visible signs of
aging.1,4 These changes are manifested in the appearance of age
spots, freckles, skin discolorations, increased skin dryness, and
wrinkles as well as increased skin laxity and atrophy.3,7
Previously, the focus of treatment for photodamage has been primarily
on facial areas but, more recently, interest in treatments to
reverse the signs of aging has expanded to include rejuvenation
of the hands.3,4,8 A number of options exist to restore the youthful
appearance of the hands. Many hand rejuvenation modalities
center on extrinsic aging with the goal to make skin pigmentation
more homogeneous (eg, bleaching creams, laser therapy)
and/or by resurfacing the skin (eg, chemical peels).9
A novel concept in premature skin aging is to recognize that
skin deterioration associated with photodamage is due to oxidative
stress on a cellular level.1 One approach to improve the
appearance of photodamaged skin of the hands is through
the use of topical agents, such as alpha-hydroxy acids and antioxidants,
with the aim of limiting the destructive effects of
oxidative stress. However, there is a paucity of clinical data that
clearly describe the efficacy of such an approach.
METHODS
Study Design
This was a single-site, open-label study of a proprietary topical
treatment10 (Vivité® Vibrance Décolleté; Allergan, Inc., Irvine,
