[LITERATURE REVIEW]

The Role of Skin Care as an

Integral Component in the
Management of Acne Vulgaris
Part 2: Tolerability and Performance of a Designated Skin
Care Regimen Using a Foam Wash and Moisturizer SPF 30
in Patients with Acne Vulgaris Undergoing Active Treatment
a
JAMES Q. DEL ROSSO, DO, FAOCD; bSTACI BRANDT, PA-C
a
Clinical Professor (Adjunct Faculty Dermatology), Touro University College of Osteopathic Medicine, Henderson, Nevada;
Private Dermatology Practice, Las Vegas Skin & Cancer Clinics/West Dermatology Group, Las Vegas and Henderson, Nevada;
b
Medical Science Lead, Galderma Laboratories, Fort Worth, Texas

ABSTRACT
Proper skin care is considered to be an important component of the total management plan for patients with acne vulgaris.
A 28-day, open-label study provided both practical and scientific information on a designated skin care regimen in subjects
with acne vulgaris. The cutaneous tolerability, overall performance, and assessment of objective parameters evaluating the
epidermal permeability barrier were documented with use of a specific foaming skin cleanser and a moisturizer with an SPF
30 broad spectrum rating in actively treated subjects with acne vulgaris. The results were favorable overall with the regimen
shown to be nonirritating based on investigator and subject assessments, with high subject satisfaction and cosmetic
acceptability ratings reported for both the foaming skin cleanser and the moisturizer with an SPF 30 broad spectrum rating.
Objective instrumental testing of transepidermal water loss and epidermal hydration support that this skin care regimen
assists in correcting epidermal permeability barrier dysfunctions that are innately present in acne vulgaris, worsened during
a flare, and are known to be associated with many medications used to treat acne vulgaris. The recommendation of a
specified skin care regimen incorporated into the overall management of acne vulgaris simplifies and standardizes the
program for the patient, demonstrates a high level of interest by the clinician, and reduces the risk of the patient self-
acquiring facial skin care products that may increase skin irritation. (J Clin Aesthet Dermatol. 2013;6(12):2836.)

A
cne vulgaris (AV) is the most commonly annually in 2009 based on data captured by the US federal
encountered dermatological disorder in ambulatory government.13 A variety of medical therapies, both topical
dermatology practice in the United States regardless and systemic, are available for the treatment of AV, with
of ethnicity, gender, or skin color, comprising selection of therapy for a given patient based primarily on
approximately 10 percent of office visits to dermatologists the current severity at the time of presentation and history

DISCLOSURE: Dr. Del Rosso has served as a consultant, advisory board participant, clinical investigator, and/or speaker for Allergan, Bayer
Healthcare (Dermatology), Eisai, Galderma, Medicis (a division of Valeant), Obagi Medical Products, Onset Dermatologics, PharmaDerm, Primus,
Promius, Quinnova, Ranbaxy, Taro Pharmaceuticals, TriaBeauty, Unilever, Valeant, and Warner-Chilcott. Dr. Del Rosso has served as a consultant
for Galderma Laboratories on the subjects of acne, acne treatments, skin care, and skin care products including the products discussed in this
article. He has received compensation for these services including his participation with this article (Part 2). This article was written by the authors
and submitted to the journal by the lead author. Internal review by Galderma was completed to evaluate for accuracy of content prior to submission
to the journal. After journal submission, the lead author served as the single point of contact with the journal and completed finalization of the
article including any response to queries that arose during peer review and/or editorial review by journal staff. Ms. Brandt is an employee of
Galderma Laboratories, L.P.
ADDRESS CORRESPONDENCE TO: James Q. Del Rosso, DO; E-mail: jqdelrosso@yahoo.com

28 [December 2013 Volume 6 Number 12] 28

of previous treatments.46 One of the major limitations of that they pre-emptively recommend the use of a
topical therapies for AV, especially for facial AV, is the moisturizer/barrier repair product when prescribing oral
relatively high potential for tolerability reactions isotretinoin, approximately 30 percent stated that their
characterized by visible signs (i.e., erythema, scaling, approach is to wait for adverse cutaneous effects to emerge
peeling, edema, dryness, roughness) and/or symptoms (i.e., clinically before they address the problem, and
stinging, burning) of cutaneous irritation.410 These approximately half (47.8%) reported that they do not
reactions can result from direct effects of active ingredient recommend use of a moisturizer in oral isotretinoin-treated
(i.e., retinoid, benzoyl peroxide [BP]) and/or the patients.27 The low percentage of dermatologists
characteristics of the vehicle, with patients in some cases recommending adjunctive skin care in patients with AV
electing to discontinue treatment or use therapy undergoing oral isotretinoin therapy is especially surprising
intermittently, which usually results in less than optimal as it is well known that this agent induces xerotic skin
therapeutic outcomes.1117 Sometimes, patients do not follow changes that are usually clinically apparent.46,27 It is evident
up with their dermatologist for further care after that more research and careful observation are needed
experiencing skin irritation from topical medications, which regarding AV and the role of skin care, optimal formulation
is unfortunate as the inflammation driving the disorder characteristics, and methods of integration with topical
continues unchecked. Other times, patients treated with therapies to assist clinicians in this important area of clinical
topical agents for AV try to work through the challenges of practice. Dermatology practitioners are commonly
skin tolerability reactions, such as redness, peeling, and confronted with many patients with AV who have questions
symptoms of skin irritation (i.e., stinging, burning, itching) about which skin care products to use, and when not given
by changing to spot application of medications to only specified information from the dermatology practice where
acne lesions, using therapy less frequently and/or self- they sought care, often seek advice from a variety of non-
treating with moisturizer application to diminish the professional sources via retail stores, spas, skin care centers,
adverse visible signs and symptoms of irritated facial skin.18 and the internet.
Interestingly, many dermatologists do not regularly Despite the relative lack of clinical research in the area of
recommend pre-emptive adjunctive skin care from the start skin care and AV, the importance of rationally selected
when initiating therapy for AV, which almost always includes adjunctive gentle skin care as an integral component of the
one or more topical medications that are well-known to overall management of several skin disorders (i.e., AV,
induce signs and symptoms of skin irritation in some rosacea, psoriasis, atopic dermatitis, other eczematous/
patients, especially during the first 2 to 4 weeks of xerotic skin disorders) has received much greater
treatment.27 Additionally, published guidelines on the recognition in the dermatology literature and at major
management of AV do not consistently address, especially in dermatology meetings over the past decade and continues
detail, the scientific and therapeutic principles that support to be an important subject to clinicians. This high level of
rationally selected skin care, proper product selection, and current interest in proper skin care in patients with
the importance of dermatologist-directed skin care in the common skin disorders such as AV is based on both vigilant
management of AV, likely due to the relative absence of clinical observation and the steady increase in peer-
clinical research that has strong evidence-based ranking.46 reviewed publications and presentations that discuss both
Such research is limited by the fact that the vast majority of the practical implications and available scientific
skin care products, even those designated for use in patients evidence.1116,1825,2732
with specific skin disorders (i.e., AV, eczema, psoriasis, This article is Part 2 in a two-part series on the
rosacea), are obtained over-the-counter (OTC) without importance of proper skin care in the management of AV.
need for a prescription and are not subject to the The results of a 28-day, open-label, single-center clinical
requirements for extensive clinical study before being study evaluating the use of a designated skin care regimen
introduced into the marketplace. Publications on the nuts in 91 patients who were already undergoing stabilized
and bolts of how to most effectively integrate skin care into treatment for AV for at least 30 days are presented. The age
the therapeutic regimen for AV are also lacking, as are an range of patients included in the study was from 12 years to
adequate number of studies that incorporate established 45 years, allowing for inclusion of adolescents and adults
subjective and objective measures that are scientifically who were actively affected by AV. This is relevant clinically
sound and well-recognized to demonstrate additive benefit as both populations are commonly encountered in clinical
that is clinically relevant. However, more data are practice, with the recruitment design favoring a targeted
progressively emerging, and the importance of gentle skin number of adult women as this population has been
care and avoiding agents that can promote epidermal barrier identified as increasing in clinical practice.26
impairment and exacerbate skin irritation are well- The designated skin care regimen defined in the study
recognized in the dermatology literature and by an protocol included a specified brand foam wash (FW;
increasing number of clinicians in practice.11,12,22,2832 Cetaphil DermaControl Foam Wash, Galderma
Nevertheless, the concept of dermatologist-selected pre- Laboratories, Fort Worth, Texas) used twice daily and a
emptive skin care in AV still requires more educational effort specified brand moisturizer with broad spectrum
and additional clinical research. Interestingly, only six photoprotection (M-SPF30; Cetaphil DermaControl
percent of 116 dermatology practitioners surveyed reported Moisturizer SPF 30, Galderma Laboratories) applied once

[ December 2013 Volume 6 Number 12] 29

 loss [TEWL], epidermal hydration by skin impedance
TABLE 1. Patient demographics and disposition [corneometry]) of the combined use of the FW and M-
SPF30 in patients already using a stable regimen of topical
ENROLLED, N 97
acne medications for at least one month before enrollment
in the study.

METHODS
Overall study design. General design. This was a
91 single-center, open-label clinical trial designed primarily to
(4 noncompliant, 1 lost to follow-up, assess the cutaneous tolerability, overall performance, and
COMPLETED STUDY, N
1 protocol violation)
cosmetic acceptability of a designated regimen containing
two skin care formulations, a facial skin cleanser (foam
wash) and moisturizer with broad spectrum sunscreen
activity (moisturizer SPF 30). The protocol requirement
was that the study be completed in otherwise healthy
18.4 years (SD+/-7.6 years) subjects with AV who are actively undergoing therapy for
age range 1245 years AV with a stable regimen for at least one month. The study
MEAN AGE, YEARS median age 16 years was conducted in compliance with the Declaration of
71 subjects (78%) between ages 12 Helsinki and current Good Clinical Practice guidelines. An
and 19 institutional review board (IRB; IntegReview; Austin,
Texas) approved the study protocols and related
documents and forms. All potential subjects were informed
GENDER, N (%) regarding the study details with all informed consent
Male 40 (44%) information provided prior to deciding on their participation
Female 51 (56%) in the study. All enrolled subjects were given written
informed consent materials, which were required from the
subject for entry into the study and from a legal guardian if
ETHNICITY, N (%) the patient was a minor.
Caucasian 36 (39.6%) Study products. All study subjects used Cetaphil
African American 36 (39.6%) DermaControl Foam Wash (FW; Galderma Laboratories,
Hispanic 14 (15.4%) Fort Worth, Texas) twice daily (morning and evening) and
Native American 1 (1.1%) Cetaphil DermaControl Moisturizer SPF 30 (M-SPF30;
Other 4 (4.4%)
Galderma Laboratories) once daily (morning after
cleansing) for 28 days. Both products were provided
daily in the morning. These skin care products are directly to each enrolled subject.
commercially available and were developed and formulated Study assessments. The study design purposefully
for use in acne-prone and acne-affected skin with the enrolled two groups of subjects, each group completing
choice of ingredients chosen to address common skin- different study courses with regard to follow up and certain
related needs of patients with AV. The development and study procedures. All subjects in both study groups
formulation characteristics of both the FW and M-SPF30 underwent completion of subjective and objective
are reviewed in more detail in Part 1 of this two-part series assessments of specific parameters. With subjective
(DelRosso JQ. The Role of Skin Care as an Integral assessments of facial skin tolerability, subjects were asked
Component in the Management of Acne Vulgaris. Part 1: about the occurrence of facial skin symptoms occurring over
The Importance of Cleanser and Moisturizer Ingredients, the course of the study, specifically itching, burning,
Design, and Product Selection. J Clin Aesthet Dermatol. stinging, and skin tightness. Objective assessments of facial
2013;6[12]), and later in the discussion section of this skin tolerability were completed by the investigator, who was
article. a board-certified dermatologist, with evaluation of visible
The major objectives of this study were to evaluate the signs associated with facial skin irritation or intolerance,
cutaneous tolerability, overall performance, and cosmetic specifically erythema, edema, dryness, and roughness. All
acceptability of the designated skin care regimen in patients study subjects had facial photographs taken at the study
who were already undergoing treatment for clinically center at baseline and at each follow-up visit through
evident AV. Other study parameters documented patient completion of the study using the second generation VISIA
satisfaction outcomes (N=91) at the end of the study (Day CR system (Canfield Scientific, Fairfield, New Jersey).
28) including the cosmetic acceptability and performance Study groups. The enrollment target was a total of 80
of the skin care regimen. In addition, objective instrumental study subjects, 40 per group. Subjects enrolled into study
testing was completed in a subset of study subjects (n=47) group 1 (G1) had subjective and objective assessments
to determine the epidermal permeability barrier completed and facial photographs obtained at baseline, Day
repair/maintenance properties (i.e., transepidermal water 14, and Day 28 (end of study). The subset of subjects

30 [December 2013 Volume 6 Number 12] 30

enrolled into study group 2 (G2) underwent subjective and
objective assessments, facial photography, and instrumental TABLE 2. Concurrent acne treatments used by study
measurements to assess TEWL and epidermal hydration subjects (%)
status of facial skin obtained at baseline, Day 14, and Day 28
(end of study). At Day 7, the subjects in G2 underwent all NUMBER OF CONCURRENT ACNE TREATMENTS
the same assessments except for the objective assessment of [SUBJECTS, N (%)]
1 treatment 58 (59.8)
facial skin tolerability by the investigator. All study subjects
2 treatments 28 (28.9)
(G1 and G2 groups) completed a cosmetic acceptability 3 treatments 6 (6.2)
questionnaire at the end of the study (Day 28). 4 treatments 4 (4.1)
Instrumental measurements. The instrumental 5 treatments 1 (1.0)
measurements completed in G2 were included to
objectively and quantitatively document recognized TOTAL NUMBER OF OTC* OR RX** ACNE
parameters that assess epidermal (stratum corneum) PRODUCTS#
OTC 104
permeability barrier function. TEWL was measured using a
Rx 49
Tewameter 300, and epidermal hydration was measured by
skin impedance testing (corneometry) using the NOVA TYPES OF ACNE TREATMENT PRODUCTS
DPM 9003. OTC cleanser 53
Adverse events. Adverse events (AEs) were recorded Non-acne Rx 16
throughout the study. A technician asked each subject at OTC spot treatment 15
each visit about facial skin irritation and any other AEs and OTC medicated pad/wipes 15
also confirmed any concomitant medications used during Rx combination topical 15
the study, including changes from visit to visit. Subjects Oral contraceptives 7
were given diaries to record time of application, any Oral antibiotics 5
Topical antibiotics 5
product performance observations they observed, and any
OTC medicated lotion 5
comments on skin tolerability and safety. OTC mask/scrub 4
OTC acne kit 4
STUDY SUBJECTS OTC moisturizer 4
Enrollment considerations. The study protocol Oral isotretinoin 3
allowed for inclusion of males or females with currently Rx topical retinoid 2
active AV who were between the ages of 12 and 45 years. All
enrolled subjects were required to be undergoing their *OTC=over-the-counter; **Rx=presciption
current treatment for AV for at least one month before the #Note that number of treatments is greater than 97 as subjects may
start of the study. A dedicated effort was made to ensure have been on more than one acne treatment.
that approximately 75 percent of the enrolled subjects were
between the ages of 12 and 19 years and that the majority contraceptives. OTC acne treatments included acne
of the remaining adult subjects were female. Individuals cleansers and moisturizers, benzoyl peroxide products,
with any visible dermatological disorder or abnormal skin salicylic acid products, medicated wipes or pads, acne
pigmentation (including tattoos) that may have interfered masks or scrubs, and acne medicated lotions.
with subjective or objective study assessments were Of the 97 subjects screened, 58 subjects (59.8%)
excluded. Pregnant females were excluded from the study. reported only one concomitant medication, and 28 subjects
Subject disposition. A total of 97 subjects were (28.9%) reported two concomitant medications. Of note,
enrolled with 91 subjects completing the 28-day study some subjects reported they had used more than four
(Table 1). Reasons for lack of study completion in six concomitant acne treatments and more than 14 different
enrolled subjects were noncompliance (n=4), lost to follow OTC acne brands. Table 2 outlines the concomitant
up (n=1), and protocol violation (n=1). medications reported by the subjects.
G1 included 44 subjects and G2 included 47 subjects.
Seventy-eight percent of subjects who completed the study STATISTICAL ANALYSIS
were between the ages of 12 and 19 years. Subjective and objective tolerability scores were
compared to baseline scores using a Wilcoxon signed-rank
CONCURRENT ACNE TREATMENT test. Bioinstrumentation data were compared to baseline
The protocol inclusion criteria required that all subjects values using a paired t-test. A binomial test with a priori
be currently undergoing stable acne treatment for at least 50/50 distribution assumption was used to determine
one month prior to study entry and with no anticipated significance to questionnaire responses. Subjects who
change in acne medication for the length of the study. Acne agreed with the product attribute were placed into the
treatments were defined as either prescription (Rx) or success category and those who did not agree with the
over-the-counter (OTC) acne products. Rx acne treatments attribute were placed into the failure category. Subjects
included topical and oral antibiotics, topical retinoids, who did not agree or disagree were pooled with the negative
topical combination products, oral isotretinoin, and oral responses. All data were analyzed at the 95% confidence

[ December 2013 Volume 6 Number 12] 31

 TABLE 3. Mean facial skin tolerability scores by subjective assessment (study subjects)

MEAN SCORE#

Baseline (n=94) Day 7 (n=48) Day 14 (n=91) Day 28 (n=91)

Itching 0.02 0.02 0.00 0.00

P value* 1.000 1.000 1.000

Burning 0.00 0.00 0.00 0.00

P value* N/C N/C N/C

Stinging 0.02 0.00 0.00 0.00

P value* 1.000 1.000 1.000

Tightness 0.03 0.06 0.01 0.02

P value* 1.000 .750 1.000

*P value relative to baseline; #4-point rating scale (03): 0=none, 1=mild, 2=moderate, 3=severe
N/C=not calculated due to zero values.

TABLE 4. Mean facial skin tolerability scores by objective assessment (investigator)

MEAN SCORE#

Baseline (n=94) Day14 (n=91) Day 28 (n=91)

Erythema 0.22 0.33 0.20

P value* 0.059 .754

Edema 0.01 0.00 0.00

P value* 1.000 1.000

Dryness 0.00 0.12 0.11

P value* 0.001 0.002

Roughness 0.01 0.00 0.07

P value* 1.000 0.125

*P value relative to baseline; #4-point rating scale (03): 0=none, 1=mild, 2=moderate, 3=severe

level. Only subjects with at least one post-baseline time (n=71) were between the ages of 12 and 19 years. Female
point were included in the statistical analysis. subjects comprised 60 percent of the remaining study
population over the age of 19 years (n=12).
RESULTS Subjective assessments. There were no significant
Subject distribution. Ninety-seven subjects were differences in assessments of facial skin tolerability by the
enrolled, and 91 completed the study (Table 1). The mean study subjects for stinging, tightness, itching, and burning
age among study subjects who completed the 28-day study at any time point during the study (Table 3).
was 18.4 years and the median age was 16.0 years. Females Objective assessments. Objective facial skin
comprised 56 percent (n=51) of those who completed the tolerability assessments determined by the investigator
study. The ethnicity disposition was 39.6 percent Caucasian showed no significant changes in mean scores relative to
(n=36), 39.6 percent African American (n=36), and 15.4 baseline for erythema, edema, and roughness at any time
percent Hispanic (n=14) (Table 1). Additionally, 78 percent point during the study (Table 4). A slight but significant

32 [December 2013 Volume 6 Number 12] 32

Figure 1. Transepidermal water loss (TEWL): Change from Figure 2. Epidermal hydration: Change from baseline (% change
baseline (% change in TEWL) in epidermal hydration measured by skin impedance
[Corneometry])

increase in the mean score for facial skin dryness was products throughout the entire duration of the study. There
observed at Day 14 (P=0.001) and Day 28 (P=0.002) were no discontinuations from the study related to adverse
relative to baseline (Table 4). events including skin tolerability reactions.
Instrumental measurements. The percent change in
TEWL scores increased at Day 7 compared to baseline DISCUSSION
(3.44%); however, this was not statistically significant This clinical trial brings forth several important practical
(Figure 1). At Day 14, TEWL had decreased compared to considerations related to the use of designated skin care as
baseline (4.33%), and by Day 28, TEWL had significantly a component of the therapeutic regimen used for
decreased compared to baseline (7.83%, P=0.036) (Figure management of AV. First, the recommendation of a specific
1). Epidermal hydration slightly decreased at Day 7 facial cleanser (FW) that achieved high satisfaction ratings
(0.28%), but increased by Day 14 (6.02%) and Day 28 from study subjects and was very well tolerated, coupled
(5.71%), although comparison to baseline was not with directions on how and when to use it, simplifies the
statistically significant (Figure 2). treatment program for the patient, and obviates the need
Cosmetic acceptability. At the end of the study (Day for the patient to select a product on their own among the
28), a significant majority of subjects favorably rated FW myriad of cleansers for AV that are available in the
and M-SPF30 in all responses to the cosmetic acceptability marketplace. The subject assessments of the FW captured
questionnaire. In particular, subjects felt that FW and M- in the survey completed at the end of the study were highly
SPF30 were easily incorporated into their daily skin routine favorable with the following percent of study subjects
(FW=96.7%; M-SPF30=95.6%), were nonirritating noting specific observations about the FW:
(FW=94.5%; M-SPF30=96.7%), liked the texture (feel) of 96.7 percenteasy to apply
the products (FW=95.6%; M-SPF30=92.3%), would 92.5 percentleft skin feeling smooth and soft
recommend them to family and friends (FW=96.7%; M- 94.5 percentnot irritating
SPF30=95.6%), and had a positive overall impression of the 97.8 percentdid not cause stinging or burning of
skin care products (FW=93.4%; M-SPF30=91.2%). To add, facial skin
more than 85 percent of the 91 subjects completing the 81.6 percenteasily removed makeup
study believed the M-SPF30 helped improve the facial skin 96.7 percenteasy to incorporate into their daily
tolerability of the medications they were using for routine
treatment of AV. 81.3 percenteasier to use than current cleanser due
Facial skin tolerability. There were no statistically to foaming properties
significant increases in erythema, edema, or roughness as 62.6 percentpreferred over currently used skin
compared to baseline after 14 days and 28 days of use of the cleanser.
FW and M-SPF30 products. The investigator assessment of Simplification for the patient is also true with the
increased mean score for facial skin dryness at both Day 14 recommendation of a designated moisturizer (M-SPF30),
(p=0.001) and Day 28 (p=0.002) did not appear to be which, in addition to providing skin hydration and aiding in
clinically relevant when compared to patient-assessed repair of the epidermal permeability barrier, also provides
dryness as only one patient reported moderate dryness ultraviolet B (UVB) and UVA photoprotection rated as SPF
during the study and continued to use the FW and M-SPF30 30. The M-SPF30 was evaluated for both UVA and UVB

[ December 2013 Volume 6 Number 12] 33

photoprotection using the most recently required testing improvement of epidermal permeability barrier function
methods and successfully achieved the broad spectrum after 14 days and 28 days. This further exemplifies the
designation and a sun protection factor (SPF) rating of importance of pre-emptive gentle skin care in patients who
30.33,34 The built in photoprotection component of M- are undergoing medical treatment for AV.
SPF30 is especially important for patients with AV, as the What are the characteristics of the FW and the M-SPF30
recommendation to avoid sun exposure and use sunscreen that suggest specific adaptability for patients with acne-
is included in the product information and approved prone skin and acne-affected skin, including those
package inserts of many topical and oral medications used undergoing treatment for AV? The development and
to treat AV, such as those containing a topical retinoid, formulation characteristics of both the FW and M-SPF30 are
benzoyl peroxide, or a tetracycline class antibiotic.3540 The available from the medical services department of the
M-SPF30 was also rated high in many patient satisfaction manufacturer and have been reviewed in Part 1 of this two-
and cosmetic acceptability parameters in this current study, part article series; however, a summary is provided below.33,41
with the following percent of patients noting specific The development of a facial wash that is adaptable for
observations about M-SPF30: use on acne-prone skin, acne-affected skin, and acne-
87.9 percentimproved skin tolerability with use of treated skin warrants a product that can lather enough to
acne medications remove sebum and other unwanted material present on the
86.8 percentallowed them to not miss applications skin surface (i.e., dirt, makeup, desquamated
of acne medications corneocytes), as many patients with AV have increased
85.7 percenthelped overall treatment. facial sebum production.42 The cleanser must be easy to
The investigator assessments of facial skin tolerability apply, cosmetically pleasing, and have minimal potential for
did not demonstrate any concerning signals with use of the inducing skin irritation. The FW used in the study achieved
combined skin care regimen (FW and M-SPF30). Dryness high subject satisfaction and cosmetic acceptability ratings
was perceived by the investigator as a mean change among for all of these characteristics. Important excipients in the
the subjects as compared to baseline; however, it was not FW are glycerin (humectant), dipotassium glycyrrhizate
determined to be of the magnitude to suggest any major (anti-inflammatory effects), and polyethylene glycol
clinical relevance. To add, the change in assessment of congeners (lubricant and dispersant with low irritation
dryness perceived by the investigator did not correlate with potential), all agents included to minimize cutaneous
the study patient assessments. The patients in the study did irritation and to impart a smooth skin texture.33,41 The major
not identify facial skin dryness as a major concern with the advance included in the FW is the novel surfactant, zinc
exception of one patient who reported moderate facial coceth sulfate, which exhibits effective detergent qualities
dryness and did not discontinue use of FW or M-SPF30 to cleanse skin, produces enough lather to be perceived as
during the study. effective by those using it, has a low irritation potential,
The results obtained from measurements of TEWL and and exerts the ability to maintain function at lower ranges
epidermal hydration that were completed in 47 of the 91 of pH.33,41,43
enrolled subjects who completed the study may be As with the FW, the M-SPF30 achieved very high subject
misleading if one views the data in a cursory manner. The satisfaction and cosmetic acceptability ratings in this study
data are interpreted more accurately if one considers that of actively treated AV. The M-SPF30 moisturizer
these results reflect the reparative effects of the skin care formulation includes several ingredients that were
regimen (FW and M-SPF30) on epidermal barrier function incorporated to address specific challenges that occur in
during acne treatment. The reparative properties of the acne-prone skin, acne-affected skin, and acne-treated skin.
skin care regimen offset the ongoing effects of concurrently Ingredients included in the M-SPF30 to assist with
used topical and/or oral acne therapies, which are known to epidermal permeability barrier repair and maintenance are
induce impairment of the epidermal permeability barrier by a ceramide precursor (pseudoceramide 5), glycerin
increasing TEWL.1116,27 In other words, the ultimate (humectant), and dimethicone (occlusive emollient).33
outcome measures of decreased TEWL and increased Other excipients included to aid in reducing the potential
epidermal hydration represent the ability of the skin care for skin irritation and also reported to exhibit anti-
regimen (FW and M-SPF30) to achieve the following two inflammatory effects are allantoin, panthenol, and
main objectives that support the use of a designated skin glycerretinic acid.44,45 Silica microbeads and corn starch are
care regimen in patients with acne: (1) help repair and included as sebum absorbants adaptable for patients with
maintain epidermal permeability barrier function when oily skin to reduce facial shine and skin
used concurrently with topical and/or oral acne medications oiliness/greasiness, but are not problematic for patients
known to impair the permeability barrier and (2) help to with normal or dry skin.33,41 A matte-effect powder is also
offset the epidermal permeability barrier impairment included to produce a smooth, non-shiny overall
associated with AV both inherently and secondary to appearance to facial skin.33,41 Broad spectrum SPF 30
inflammation that occurs during an acne flare.11,13,14 The photoprotection is provided through the inclusion of
TEWL and epidermal hydration results demonstrate that avobenzone 3%, octisalate 5%, and octocrylene 7%, which
the skin care regimen (FW and M-SPF30) when used are partitioned in plant-derived, lipid-based, lamellar
concomitantly with AV medications contributes to the spheres called oleosomes.46,47 The partitioning of the

34 [December 2013 Volume 6 Number 12]

individual sunscreen components into the oleosomes update on efficacy and safety. Am J Clin Dermatol.
increases their stability by preventing their physical 2008;9(6):369381.
interaction prior to application, allowing for a total 8. Leyden JJ, Tanghetti EA, Miller B, et al. Once daily tazarotene
sunscreen ingredient concentration of 15% with an SPF 30 0.1% gel versus once daily tretinoin 0.1% microsponge gel for
rating.33,41 This concentration is markedly lower than what is the treatment of facial acne vulgaris: a double blind
typically needed to achieve an SPF 30 based on randomized trial. Cutis. 2002;70(5):295298.
comparisons with other commercially available daily facial 9. Galvin SA, Gilbert R, Baker M, et al. Comparative tolerance of
moisturizer SPF 30 products, with the lower sunscreen adapalene 0.1% and six different tretinoin formulations. Br J
concentration more likely to reduce the risk of cutaneous Dermatol. 1998;139(Suppl 52):3440.
irritation.33 10. Gold LS, Tan J, Cruz-Santana A, et al. Adapalene-BPO study
This 28-day, open label clinical study provided practical group: a North American study of adapalene-benzoyl
and scientific information on designated skin care in peroxide combination gel in the treatment of acne. Cutis.
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