Journal of Dermatological Treatment.

2008; 19: 327–332

ORIGINAL ARTICLE

Patient-reported outcomes from a multicenter, randomized,

TM
vehicle-
controlled clinical study of MAS063DP (Atopiclair ) in the
management of mild-to-moderate atopic dermatitis in adults

WILLIAM ABRAMOVITS1, ADELAIDE A. HEBERT2, MARK BOGUNIEWICZ3,

STEVEN E. KEMPERS4, EDUARDO TSCHEN5, MICHAEL T. JARRATT6,
ANNE W. LUCKY7, RAYMOND L. CORNELISON8, LEONARD J. SWINYER9 &
J Dermatolog Treat Downloaded from informahealthcare.com by Chulalonkorn University on 05/05/11

TERRY M. JONES10
1
Department of Dermatology, Baylor University Medical Center and University of Texas Southwestern School of Medicine,
Dallas, TX, USA / Dermatology Treatment & Research Center, Dallas, TX, USA, 2Department of Dermatology, University
of Texas—Houston, Houston, TX, USA, 3Division of Allergy-Immunology, Department of Pediatrics, National Jewish
Medical and Research Center and University of Colorado School of Medicine, Denver, CO, USA, 4Minnesota Clinical Study
Center, Fridley, MN, USA, 5Academic Dermatology Associates, Albuquerque, NM, USA, 6DermResearch Inc., Austin, TX,
USA, 7Dermatology Research Associates, Cincinnati, OH, USA, 8Department of Dermatology, University of Oklahoma
Health Sciences Center, Oklahoma City, OK, USA, 9Dermatology Research Center, Salt Lake City, UT, USA, and 10J&S
Studies, Bryan, TX, USA
For personal use only.

Abstract TM
Background: MAS063DP (Atopiclair ) is a topical cream approved for symptomatic relief in the treatment of atopic and
contact dermatitis. Methods: This was a multicenter, randomized, double-blind, vehicle-controlled study in adults with
mild–moderate atopic dermatitis. Patients were given MAS063DP or vehicle (2:1) three times per day to areas affected by
atopic dermatitis for up to 50 days. A patient global assessment change from baseline was determined at days 8, 22, 36, and
50. Patient total body pruritus (visual analog scale) and patient opinion on treatment acceptability were also assessed.
Results: A total of 218 patients (active: n5145, vehicle: n573) were enrolled. At Day 22, 77% of patients on MAS063DP
had a patient global assessment of good improvement or better versus 21% on vehicle (pv0.0001, chi-squared test).
Similarly, more patients had improvement in itch over their total body on MAS063DP than on vehicle (pv0.0001).
Conclusion: MAS063DP treatment results in patient-perceived improvements in mild–moderate atopic dermatitis.

Key words: Atopic dermatitis, MAS063DP, non-steroidal, topical treatment

Introduction barrier. A characteristic finding in AD patients is

Atopic dermatitis (AD) is a chronic inflammatory
condition of the skin that affects individuals of all
ages. It is characterized by intense pruritus with a
course marked by exacerbations and remissions.
The pruritus has a major negative effect on a
patient’s quality of life, causing sleep disruption,
irritability, and generalized stress for affected
patients and family members, as well as exacting
meaningful personal and societal financial costs (1–
3). Pruritus leads to scratching which results in
secondary skin changes such as lichenification,
excoriations, and further breakdown of the skin
xerosis of the skin. Xerotic skin is relatively unable
to hold moisture, thus it is less pliable and more
likely to crack and fissure. Skin barrier breakdown
increases susceptibility to irritation and infection.
Treatment of AD is aimed at reversing pruritus,
xerosis, inflammation and secondary infections (4).
Therapy of AD is an ever-changing paradigm
involving patient and caregiver education, treatment
with topical corticosteroids and non-steroidal anti-
inflammatory agents such as calcineurin inhibitors
and novel agents, frequent use of emollients to aid
skin hydration and sometimes use of systemic agents
and phototherapy (5). However, the pruritus of AD

Correspondence: William Abramovits, Dermatology Treatment & Research Center, 5310 Harvest Hill, Suite 160, Dallas, TX 75230, USA. E-mail:
DrA@DermCenter.us

(Received 15 May 2008; accepted 25 May 2008)

ISSN 0954-6634 print/ISSN 1471-1753 online # 2008 Informa UK Ltd.
DOI: 10.1080/09546630802232799
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 328 W. Abramovits et al.
may be particularly difficult to suppress with the
available topical medications (6–8). Topical corti-
costeroids remain the standard of care for treating
AD, but concerns about local side effects including
skin atrophy, as well as systemic effects such as
hypothalamic-pituitary-axis suppression are of con-
cern (9,10). Topical calcineurin inhibitors such a
tacrolimus and pimecrolimus also have been shown
to reduce the extent, severity, and symptoms of AD,
but their application is associated with some burning
on application and a questionable risk for skin
cancer was recently raised (9,11,12). Hence, novel
topical treatments that rapidly suppress itch and
reduce the affected body surface area and lesion
severity without these potential adverse effects
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would be very welcomed by patients living with AD.
TM
MAS063DP (Atopiclair , ZarzendaH) is a novel
non-steroidal cream indicated for the management
of AD. This cream contains glycyrrhetinic acid
(GA), extract from Vitis vinifera, telmesteine. GA,
a major component of licorice (Glycyrrhiza glabra),
has anti-inflammatory effects (13–15), possibly
mediated through inhibition of 11-b-hydroxysteroid
dehydrogenase, an enzyme that interconverts active
cortisol to and from inactive cortisone; this inhibi-
tion may increase the cortisol available for binding to
For personal use only.
local glucocorticoid receptors, including in the skin
(16–18). GA also has been reported to inhibit the
complement cascade (19), IgE-mediated degranula-
tion (20), histamine synthesis and release (21),
TNF-alpha-mediated IL-8 production and p38
MAPK phosphorylation (22), as well as leukotriene
C4 release (23). The bioflavonoids in the Vitis
vinifera extract have been reported to have antiox-
idant activity (24). The shea butter in the formula-
tion, which is derived from Butyrospermum parkii and
purified to eliminate antigenic protein, contains
triglycerides and fatty acids as well as phytosterols
and tocopherols. In addition to liposoluble and
hydrosoluble moisturizers/emollients, the formula-
tion contains hyaluronate, a physiological constitu-
ent of the extra-cellular matrix of the dermis, which
has hygroscopic and wound healing properties (25),
and telmesteine, which has antielastase and antic-
ollagenase activity in vitro and inhibits metallopro-
teinases that are over-expressed in AD (26,27).
A recent multi-center, randomized, vehicle-controlled
clinical study showed the safety and efficacy of
MAS063DP in the long-term management of mild-
to-moderate AD in adults (28). Furthermore,
MAS063DP treatment was not associated with local
irritation and contact dermatitis; burning on applica-
tion was reported rarely.
As new therapies for AD become available, it is
important to evaluate its patient-reported outcomes
and acceptance, as non-compliance with topical
therapy is very common and will likely affect the
response in actual clinical practice. Formulation
characteristics such as ease or difficulty of use,
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cosmetic acceptability, odor, and staining are recog-
nized to affect patients’ preferences. We report
herein on patient-reported outcomes and acceptance
of MAS063DP treatment from a clinical study on
the management of mild-to-moderate AD in adults,
for which safety and efficacy have been previously
reported (28).
Materials and methods
The study design and methods have been described
previously (28). In brief, male and female patients
aged 18 or over with mild-to-moderate AD accord-
ing to the criteria of Hanifin and Rajka (29) and
Rajka and Langeland (30), were enrolled at 10 study
centers in the United States. Patients were excluded
if they had severe AD, an active skin infection
requiring antimicrobial treatment, a history of
allergy to study cream components, previous treat-
ment with MAS063DP, or another skin or systemic
condition that could interfere with study participa-
tion. Topical corticosteroids, immunomodulators,
antihistamines, non-steroidal anti-inflammatory
drugs and phototherapy were excluded during a
washout period prior to treatment initiation and
during the study. The study was approved by the
institutional review board of each center and all
patients provided written informed consent.
Patients were randomized (2:1) to MAS063DP or
vehicle cream (Sinclair Pharma Ltd, Godalming,
United Kingdom). The study cream was adminis-
tered to all areas affected by AD three times per day
for up to 50 days. Patients were assessed at baseline
(Day 1) and Days 8, 22, 36, and 50. The primary
study outcome measure was the eczema area and
severity index (EASI) at Day 22; additional investi-
gator assessments have been previously described
(28). The patient-reported outcomes included the
patient global assessment (PGA) of clinical improve-
ment from baseline and itch over total body
improvement from baseline (both using an individual
assessment score ranging from 21 [worse] to 3 [total
resolution]). In addition, at the completion of the
study, patient acceptability of the study cream
formulation was assessed (willingness to continue
on study substance, effectiveness compared with prior
treatments, ease of use/spreading; cosmetic accept-
ability, odor and staining of clothing). Analyses
(SASH, System for Microsoft Windows, Release 8.2;
SAS’ Institute Inc., Cary, NC, USA) were performed
on the intent-to-treat (ITT) population using the last
observation carried forward method for missing data.
Results
Patient disposition
Of the 218 patients enrolled, 145 (66.5%) were
randomized to MAS063DP and 73 (33.5%) to
 AD patient-reported outcomes with MAS063DP
vehicle. Of the 32 (14.6%) of patients who did not
complete the study, the most common reasons for
withdrawal were ‘use of prohibited medication’ (six
of 16 patients) in the MAS063DP group and
‘consent withdrawal’ or ‘need for additional topical
or systemic medication for their AD’ (seven and six
of 16 patients, respectively).
Baseline characteristics
There were 127 females and 91 males (aged 18–84
years) with a duration of the current episode of AD
ranging from 5 days to 58 years. The majority of
patients were Caucasian (73%). The most common
AD pattern was constant or frequent (80% of
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patients) and with no seasonal course (66%).
Almost 50% of patients had pruritus, lichenification,
chronic relapsing course and family history of atopy;
greater than 65% reported a history of allergy.
Affected area(s) included head and neck in 11% in
both treatment groups, upper limbs in 44% and
40%, on trunk in 13% and 18%, and on lower limbs
in 32% and 32%, in MAS063DP and vehicle
groups, respectively. No statistically significant
difference between treatment groups was found for
baseline characteristics (28).
For personal use only.
Efficacy
PGA. More MAS063DP-treated patients (ITT
population) experienced improvement compared to
baseline in their individual PGA than vehicle-treated
patients at all times (chi-squared test, pv0.0001). A
PGA of good improvement or total resolution was
achieved in 77% of MAS063PD-treated patients
versus 21% of vehicle-patients at Day 22
(Figure 1A). At Day 50, fewer MAS063PD-treated
patients had worsening in individual PGAs than
vehicle-treated patients (Figure 1B). Similar results
Figure 1. Improvement in patient global assessment compared to baseline at Day 22 (A) and Day 50 (B). Difference in treatment groups
was significant (pv0.0001, chi-squared test). Intent-to-treat population (n5216), last observation carried forward.
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329
were observed for the per protocol (PP) population,
accounting for patients who used rescue medications
(data not shown).
Patient’s assessment of improvement in itch. More
MAS063DP-treated patients (ITT population)
experienced improvement compared to baseline in
their assessments of itch over total body than
vehicle-treated patients at all times (chi-squared
test, pv0.0001). An assessment of good improve-
ment or total resolution was achieved in 78% of
MAS063PD-treated patients versus 27% of vehicle
patients at Day 22 (Figure 2A). At Day 50, fewer
MAS063PD-treated patients had worsening in itch
than vehicle-treated patients (Figure 2B). Similar
results were observed for the PP population (data
not shown).
Patients’ opinion of acceptability of study cream.
Acceptability for the study cream was greater in the
MAS063DP-treated group than the vehicle-treated
group with respect to ‘willingness to continue’ on
study cream (pv0.0001, chi-squared), study cream
‘odor’ (pv0.05) and ‘effectiveness’ compared to prior
treatments (pv0.0001) (Figure 3A–C).
Compliance
In the MAS063DP-treated group, 88.9% of the
patients self-administered the study cream for the
scheduled treatment period, compared to 78.0% of
the vehicle-treated patients.
Discussion
As no current therapy for AD is curative, continuous
or repeated treatments are necessary to stabilize and
maintain an acceptable skin condition. At present,
the selection of individual treatments for a patient
 330 W. Abramovits et al.
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Figure 2. Improvement in patient itch over total body assessment compared to baseline at Day 22 (A) and Day 50 (B). Difference in
treatment groups was significant (pv0.0001, chi-squared test). Intent-to-treat population (n5216), last observation carried forward.

mainly depends on factors such as disease severity,
age, efficacy, safety, and treatment costs, and patient
treatment compliance. The latter is often crucial to
treatment success but may be adversely impacted by
the other factors. For example, topically applied
corticosteroids remain the state-of-the-art treatment
for mild-to-moderate flare-ups (9,31,32,33,34).
However, one study reported that 73% of partici-
For personal use only.
will likely decrease clinical effectiveness and result in
higher overall treatment costs (36). While compli-
ance can be more or less controlled in clinical
studies, it is likely to be influenced by the ‘content-
edness’ of patients with the treatment modality in
daily practice, as observed for topically applied
corticosteroids (35,37). Patients who are content
with their treatment, including being able to perceive

pants had worries regarding topical corticosteroids
and 24% were non-compliant as a result of these
worries (35). In addition, AD patients often delay
initiating topical corticosteroid therapy even during
flare-ups of AD due to concerns about safety (34).
Objective clinical efficacy reported from studies are
often considered in recommending a treatment to
patients, but those that are used inappropriately or
not used at all due to non-compliance ‘in practice’
disease improvement, should be more compliant and
more likely to ‘stick’ with it.
We have previously reported that MAS063DP
significantly improved EASI scores more than
vehicle in mild-to-moderate AD patients, with a
mean treatment difference of 23.67 (95% confi-
dence interval 24.789 to 22.543) in favor of
MAS063DP at Day 22 (pv0.0001, ANCOVA)
(28). Similarly, improvement in investigator global

Figure 3. Patient opinion on study cream acceptability. (A) More MAS063DP-treated patients (92%) than vehicle-treated patients (50%)
indicated they definitely or likely would wish to continue treatment (pv0.0001, chi-squared test). (B) More MAS063DP-treated patients
(28%) than vehicle-treated patients (16%) considered the study cream smell pleasant (pv0.05, chi-squared test). (C) More MAS063DP-
treated patients (89%) than vehicle-treated patients (48%) considered the study cream more effective or more effective than some prior
treatments (pv0.0001, chi-squared test).

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assessments was greater for the MAS063DP-treated
patients than vehicle-treated patients. As might be
predicted for a treatment modality where improve-
ment in the investigator-assessed measures occur, we
also observed that MAS063DP-treated patients had
greater improvement in patient-reported outcomes,
including patient global assessment and patient
assessment of itch over total body, than vehicle-
treated patients. In addition, we observed that
compared with those assigned to vehicle, patients
assigned to MAS063DP reported they were more
willing to continue treatment, found the study cream
smell pleasant, and considered the study cream to be
more effective than prior treatments. These findings
suggest patients prescribed MAS063DP for the
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management of mild-to-moderate AD would be
accepting of such treatment. Further research is
needed to assess clinical effectiveness in a non-study
setting, effects on quality of life, and the cost-
effectiveness of this novel treatment for AD.
Acknowledgement
Declaration of interest: The authors report no
conflicts of interest other than as disclosed below.
For personal use only.
Disclosures
William Abramovits MD has been an investigator
and a consultant for Sinclair Pharma Ltd and
Graceway Pharmaceuticals, LLC, and has received
compensation for services. Adelaide A. Hebert MD
has been an investigator and a consultant for Sinclair
Pharma Ltd and Graceway Pharmaceuticals, LLC,
and has received compensation for services. Mark
Boguniewicz MD has been an investigator for
Sinclair Pharma Ltd and an investigator and con-
sultant for Graceway Pharmaceuticals, LLC, and
has received compensation for services. Steven E.
Kempers MD has been an investigator for Sinclair
Pharma Ltd and Graceway Pharmaceuticals, LLC,
and has received compensation for services. Eduardo
Tschen MD, MBA has been an investigator for
Sinclair Pharma Ltd and Graceway Pharma-
ceuticals, and has received compensation for
services. Michael T. Jarratt MD has been an
investigator and a consultant for Sinclair Pharma
Ltd and Graceway Pharmaceuticals, LLC, and has
received compensation for services. Anne W. Lucky
MD has been an investigator and consultant for
Sinclair Pharma Ltd and an investigator for
Graceway Pharmaceuticals, and has received com-
pensation for services. Raymond L. Cornelison MD
has been an investigator for Sinclair Pharma Ltd and
Graceway Pharmaceuticals, and has received com-
pensation for services. Leonard J. Swinyer MD has
been an investigator for Sinclair Pharma Ltd and
Graceway Pharmaceuticals, and has received
compensation for services. Terry M. Jones MD has
been an investigator for Sinclair Pharma Ltd and
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AD patient-reported outcomes with MAS063DP 331
Graceway Pharmaceuticals, LLC, and has received
compensation for services.
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