Clinical Evaluation of A Novel Glycolic Acid/Antioxidant-Based Antiaging Skin Care Regimen
Clinical Evaluation of A Novel Glycolic Acid/Antioxidant-Based Antiaging Skin Care Regimen
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Efficacy parameters included periodic dermatologist and expert grader evaluations, skin surface hydra-
tion, and subject self-evaluation. Adverse events, if any, were also recorded.
The mean age of the 24 subjects was 45.4 years; 23 of the 24 subjects (96%) completed the study. As
assessed by both a dermatologist and an expert grader, there were significant reductions versus base-
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line in fine lines, dryness, and tactile roughness approximately 15 minutes after a single application of
2 products from the treatment regimen (the revitalizing eye cream and the daily antioxidant facial
serum). Modest additional improvements were reported by the dermatologist, and significant improve-
ments were reported by the expert grader, after 3 weeks of treatment with all 4 products. Skin surface
hydration measured by electrical conductance also was improved significantly immediately after appli-
cation of 2 of the 4 products and after the 3-week course of treatment. Subject satisfaction, as assessed
by a posttreatment questionnaire, was high, and no adverse events were reported.
This glycolic acid/antioxidant–based 4-product topical regimen is a safe and efficacious option for
patients who want to minimize the signs of photoaging.
O
ur hedonistic impulse to diminish the 2006 Americans spent just under $12.2 billion on cos-
signs of chronologic aging and photoag- metic procedures.1 Of the nearly 11.5 million surgical
ing has fostered a burgeoning cosmetics and nonsurgical procedures performed in the United
industry. According to the American States in 2006, nonsurgical procedures comprised 83%
Society for Aesthetic Plastic Surgery, in of the total.1 Although women continue to be the primary
users (.10.5 million cosmetic procedures), the market
Dr. Downie is Director, Image Dermatology, PC, Montclair, New for cosmetics-related procedures and products is increas-
Jersey, and Assisting Attending, Overlook Hospital, Summit, New ing among men as well as among ethnic minorities.1-3
Jersey, and Mountainside Hospital, New Jersey. Modern antiaging cosmetics go well beyond the simple
Dr. Downie is a consultant, lecturer, and researcher for, and a moisturizing function of traditional antiwrinkle creams.
stockholder of, Allergan, Inc. This study was funded by a grant from They perform complex functions in terms of skin pro-
Allergan, Inc. tection, nourishment, and removal of superficial layers;
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(primarily dermatologists or, if they have undergone
cosmetic procedures, plastic surgeons) to understand Treatment Regimen
and avail themselves of noninvasive cosmetic products Prior to study initiation, all subjects underwent a 3-day
and procedures. An added advantage of using physician- pretrial conditioning period, during which they stopped
dispensed products is that there may be regulatory restric- the use of all moisturizing products on the face. Fol-
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tions (eg, restrictions imposed by the US Food and Drug
Administration) on the concentration of certain ingre-
dients that can be included in over-the-counter (OTC)
products. One such example is a-hydroxy acids (AHAs),
lowing the conditioning period, subjects were given a
skin care regimen comprised of 4 topical products to be
used as directed for a 3-week period: an exfoliating facial
cleanser to be applied once every 3 days in the evening,
which were the first molecules to start the cosmeceuti- an antioxidant facial serum to be applied once daily, a
cal revolution. Two factors determine their efficacy: renewal facial cream to be applied once every night, and
concentration and the pH of the preparation. The active a revitalizing eye cream to be applied twice daily. Subjects
ingredient in the preparation is the free acid, and the pH were allowed to use their current facial cleansers on the
of the preparation determines the proportion of free acid. 4 days of the week when they were not using the exfoliating
According to the Cosmetic Ingredient Review recommen- cleanser, but they were not allowed to use any new cleans-
dations, the concentration of AHAs in OTC cosmetics ers during the study period. Subjects were required not to
cannot exceed 10%, and the pH of the preparation cannot use any other moisturizers or topical medications, toners, or
be less than 3.5.6 Consequently, these OTC preparations astringent products on the face during the study; established
can offer only modest improvement at best. In contrast, makeup regimens could be continued, although subjects
the concentration of AHAs in physician-dispensed prod- were not allowed to change brands of makeup during the
ucts may exceed 10%. study. Subjects were instructed to avoid excessive sun expo-
GLX (glycolic acid/antioxidant) Technology is a propri- sure, and the use of tanning beds was prohibited.
etary technology that is a unique blend of AHAs (glycolic Each subject’s initial morning treatment regimen was
acid and ammonium glycolate) and natural antioxidants. performed at the laboratory under the supervision of
The formula matrix is designed to act as a catalyst for study staff to ensure adherence to the instructions for
penetration of the distinctive blend of AHAs and natural use. In addition, all subjects returned to the laboratory
antioxidants, which enhances the skin’s natural produc- on day 2 as well as on the days of their scheduled week 1
tion of hyaluronic acid and epidermal growth factor, and week 2 assessments and completed their morning
stimulates collagen, and protects epidermal cells. treatment regimens under supervision. Subjects were
This article reports on a study undertaken to evaluate the provided with a diary form to record the times of their
efficacy and tolerability of a novel skin care regimen that product applications.
Table 1
Components of a Glycolic Acid/Antioxidant–Based
Antiaging Skin Care Regimen
Daily antioxidant Antiaging actives: glycolic acid, ammonium glycolate, and natural antioxidants
facial serum Antioxidant actives: olive leaf extract, Camellia oleifera leaf extract, and Punica granatum extract
Anti-inflammatory actives: licorice extract, chamomile extract, Aloe barbadensis leaf extract, and
yeast extract
Humectant: glycerin, sodium PCA, urea, trehalose, sodium hyaluronate, phospholipids, butylene gly-
col, Stevia rebaudiana (sweet honey leaf) extract, C angustifolia seed polysaccharide, and mannitol
Emollients: bis-hydroxyethoxypropyl dimethicone, phenyl trimethicone, cyclomethicone, and
dimethiconol
Night renewal
facial cream
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Antiaging: glycolic acid, ammonium glycolate, and natural antioxidants
Skin firming: algae extract
Humectants: glycerin, sodium PCA, urea, trehalose, sodium hyaluronate, pentylene glycol, saccharide
isomerate, and sericin
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Emollients: bis-hydroxyethoxypropyl dimethicone, cyclomethicone, cyclopentasiloxane, dimethi-
cone crosspolymer, octyldodecanol, hydrogenated cocoglycerides, and Irvingia gabonensis kernel
butter (wild mango)
Antioxidant: superoxide dismutase, olive leaf extract, tocopherol, and magnesium ascorbyl phosphate
Revitalizing
Antiaging: glycolic acid, ammonium glycolate, and natural antioxidants
eye cream
Reduce puffiness: caffeine
Tightening: palmitoyl tripeptide-3 and Ceratonia siliqua gum
Interference pearls: titanium dioxide, iron oxides, and silica
Humectants: glycerin, phospholipids, carrageenans (Chondrus crispus), hydrolyzed wheat gluten,
and glucose
Emollients: phenyl trimethicone, cyclomethicone, and dimethiconol
Table 2
Study Inclusion and Exclusion Criteria
No participation in a study involving the face in Eczema, seborrheic dermatitis, psoriasis, or chapped skin
the past 30 d
Use of medications that might interfere with the study results
Willing and able to follow all study directions
Known sensitivities to cosmetics, soaps, moisturizers, etc
Willing to discontinue use of all moisturizing
products on the face 3 d before the first study Known sensitivity to a-hydroxy acid
visit and for the duration of the study Any other condition or factor that in the investigator’s opinion
may affect skin response or the interpretation of results
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Skin Surface Hydration site (suborbital and cheek areas), from which an average
Changes in skin surface hydration were measured utiliz- value for each site was computed.
ing an IBS Skicon-200 Conductance Meter equipped
with a Measurement Technologies probe. The ability of Subject Self-Assessment
an alternating current to flow through the stratum cor- Subjects were asked to complete a 1-page self-assessment
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neum is an indirect measure of stratum corneum water
content.7 For each measurement, a spring-loaded probe
tip was placed at the sample site, and 2 to 3 seconds
later alternating current conductance (expressed in units
questionnaire at the conclusion of the study (week 3).
Adverse Events
Tolerability was assessed 15 minutes postbaseline and
of millimho) was recorded. A total of 5 conductance after 1, 2, and 3 weeks. Subjects were observed as well
measurements at each time point were obtained at each as interviewed at each study visit to confirm tolerability
Table 3
Efficacy Parameters and Timelines for Evaluation
Parameter Timeline
Dermatologist evaluations (skin surface fine lines, dryness, Baseline; 15 min postbaseline; after 3 wk
tactile roughness)
Expert grader evaluations (skin surface fine lines, dryness, Baseline; 15 min postbaseline; after 2 and 3 wk
tactile roughness)
Baseline Baseline
3.0 3.5
15 Minutes Postbaseline 15 Minutes Postbaseline
(Single Application of 2 Products) (Single Application of 2 Products)
2.5 † 3.0
Week 3 (Full 4-Product Regimen) Week 2 (Full 4-Product Regimen)
‡
‡ Week 3 (Full 4-Product Regimen)
2.5
2.0
2.0
Grade*
Grade*
1.5 †
‡
1.5
‡
1.0
1.0
‡
0.5 0.5
† †
0 0
Fine Lines Dryness Tactile Roughness Fine Lines Dryness Tactile Roughness
Parameter Parameter
Figure 1. Dermatologist evaluations of fine lines, dryness, and tactile Figure 2. Expert grader evaluations of fine lines, dryness, and tactile
roughness in subjects using a glycolic acid/antioxidant–based antiag- roughness in subjects using a glycolic acid/antioxidant–based antiag-
ing skin care regimen. Asterisk indicates scales for fine lines, where ing skin care regimen. Asterisk indicates scales for fine lines, where
0–25slightly visible, 3–55moderately visible, and 6–85obvious or 0–25slightly visible, 3–55moderately visible, and 6–85obvious or
very marked; dryness, where 05none, 1–55mild to moderate flaking very marked; dryness, where 05none, 1–55mild to moderate flaking
or scaling, and 6–85severe scaling or fissuring; and tactile roughness, or scaling, and 6–85severe scaling or fissuring; and tactile roughness,
where 0–25slight, 3–55moderate, and 6–85extreme; dagger, P,.05 where 0–25slight, 3–55moderate, and 6–85extreme; dagger, P,.01
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vs baseline; double dagger, P,.01 vs baseline. vs baseline; double dagger, P,.05 vs baseline.
of the skin care regimen. Adverse events, whether or not time points were compared with baseline values using
they were considered to be related to the treatment regi- paired t tests. A 2-tailed P,.05 was taken as the level of
men, were documented. significance for comparisons.
Statistical Analysis
Dermatologist evaluations, expert grader evaluations,
and conductance measurements at each of the follow-up
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Twenty-four healthy volunteers, aged 35 to 55 years,
exhibiting mild to moderate facial photodamage
1200
1000 *
800 † † †
600
400
200
0
Baseline 15 Minutes Week 1 Week 2 Week 3
Postbaseline (Full 4-Product (Full 4-Product (Full 4-Product
(Single Application Regimen) Regimen) Regimen)
of 2 Products)
Time
Figure 3. Changes in electrical conductance in the skin as an indication of skin hydration in subjects using a glycolic acid/antioxidant–based
antiaging skin care regimen. Asterisk indicates P,.01 vs baseline; dagger, P,.05 vs baseline.
Table 4
Subject Self-Assessment Following Treatment With
a Glycolic Acid/Antioxidant–Based Skin Care Regimen
Responses, %
Very Satisfied/ Very Dissatisfied
Question Satisfied Indifferent /Dissatisfied*
Did the products reduce the appearance of 61 35 4
fine lines and wrinkles?
Did the products improve your skin’s softness 96 4 0
and smoothness?
Did the products improve your skin’s radiance, 61 39 0
tone, and clarity?
Did the products improve your skin’s firmness, 61 35 4
tightness, and elasticity?
Did the products improve the texture of your 61 39 0
sun-damaged skin?
overall appearance?
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Did the products improve your skin’s
70
17
30
0
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N524.
*None of the subjects indicated “Very Dissatisfied” as a response.
participated in this trial. The mean age of the regimen during 3 weeks resulted in a further reduction
24 subjects was 45.4 years; 23 of the 24 subjects (96%) in the mean scores for these parameters; however, the
completed the study. The efficacy of the GLX-based reduction was not statistically significant.
antiaging skin care regimen was evaluated based on
qualitative skin surface visual assessments performed Expert Grader Evaluations
by a physician (dermatologist) and an expert grader, Changes in the mean scores for fine lines, dryness, and
objective determination of skin surface hydration, and tactile roughness observed with treatment, as determined
self-assessment by the subjects (Figures 1-3; Table 4). by expert grader evaluations, are shown in Figure 2.
Digital photographs of the left side of the face at base- Scores for all 3 parameters were significantly reduced
line and after the 3-week, 4-product skin care regimen versus baseline (P,.01 for all) approximately 15 minutes
are presented in Figure 4. after a single application of 2 products from the treatment
regimen (the revitalizing eye cream and the daily anti-
Dermatologist Evaluations oxidant facial serum). Significantly reduced scores versus
Changes in the mean scores for fine lines, dryness, and baseline (P,.05) were also seen for fine lines at weeks 2
tactile roughness observed with treatment, as determined and 3 and for dryness at week 2.
by dermatologist evaluations, are presented in Figure 1.
There was a significant reduction versus baseline in Skin Surface Hydration
fine lines (P,.05), dryness (P,.01), and tactile rough- Changes in facial skin surface hydration observed during
ness (P,.01) approximately 15 minutes after a single the treatment period are depicted in Figure 3. Electrical
application of 2 products from the treatment regimen conductance measurements (higher conductance values
(the revitalizing eye cream and the daily antioxidant facial correspond to greater hydration) revealed an immediate
serum). Continued treatment with the full 4-product significant increase versus baseline (P,.01) in facial skin
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the daily antioxidant facial serum). Measurements in the of the 4 products in this skin care regimen contain
cheek area also showed significant though more modest high concentrations of unbuffered and buffered glycolic
increases versus baseline (P,.05) at weeks 1, 2, and 3. acid (10%–20%) combined with antioxidants and plant
In the suborbital area, a significant increase versus base- extracts. The products are formulated to facilitate deep
line (P,.05) was not seen again until week 3. It should be penetration of hydrating glycolic acid to improve skin
Conclusion
This physician-dispensed GLX-based antiaging facial
treatment regimen improved objective appearance, was
associated with satisfaction in the majority of those
treated, and did not lead to any safety or tolerabil-
ity issues in female subjects having mild to moderate
photodamaged skin. This regimen may provide a new
option for those seeking some control over the signs of
facial aging.
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