Acta Dermato-Venereologica Issue No. 97-5 97-5CompleteContent | Page 23
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SHORT COMMUNICATION
Monitoring Ingenol Mebutate Gel Treatment of Actinic Keratoses by Reflectance Confocal Microscopy
José Luis LÓPEZ ESTEBARANZ, Ana PAMPIN FRANCO, Reyes GAMO VILLEGAS and Uxua FLORISTÁN
Dermatology Service, Hospital Universitario Fundación Alcorcón, ES-28922 Madrid, Spain. E-mail: [email protected]
Accepted Jan 12, 2017; Epub ahead of print Jan 17, 2017
Actinic keratoses (AK) commonly occur in elderly
patients as a result of chronic exposure to ultraviolet
radiation (1). While isolated AK lesions are usually
treated with liquid nitrogen cryosurgery, subclinical
lesions occurring in photo-damaged areas are treated by
photodynamic therapy and topical agents (imiquimod,
5-fluoruracil, diclofenac, and ingenol mebutate) (2). The
advantages of these treatments are that they are non-
invasive, self-administered and effective against both
clinical and subclinical lesions, but most of them require
a long course of treatment and are associated with a high
frequency of local skin reactions (LSRs). The most re-
cently approved agent, ingenol mebutate (IM), needs to
be applied for only 2 or 3 days, it has a shorter duration
of LSRs, and improved adherence (3–5).
Dermoscopy and reflectance confocal microscopy
(RCM) are a help in diagnosis of AK and subsequent
monitoring of treatments (6–8). A correlation between
these techniques and histopathological examination has
been demonstrated (6, 9). RCM offers the possibility of
detecting morphological changes in clinical and sub-
clinical AK at the treated area (10) and has been used
to follow AK in response to different topical treatments
(11). Two recent studies reported successful monitoring
of morphological changes in AKs treated with IM using
a dermoscopy, optical coherence tomography and RCM
(7, 12). The aim of this case series report was to evaluate
the response to IM gel in AK treatment on the face or
scalp using RCM and clinical assessment.
METHODS
A total of 17 patients were enrolled in a prospective study of
case series. All patients were over 50 years of age, with a clinical
diagnosis of AK on the head and face, and indication for ingenol
mebutate (IM) treatment. The study was approved by the local
ethics committee and written informed consent was obtained from
each participant before evaluation.
All patients were treated with IM 0.015% gel (Picato ® , LEO
Pharma, Ballerup, Denmark) applied once daily for 3 consecu-
tive days in the affected area, covering both clinical AK and the
area surrounding the lesions (field of cancerization), and area of
approximately 25 cm 2 .
AK in the target area were examined clinically to evaluate
the treatment response at baseline and at the 8 th week follow-up
visit, while RCM imaging was performed before treatment and
at weeks 4 and 8. Images were obtained using a digital camera
(Canon PowerShot G12, Canon USA Inc., New York, USA).
Lesions were rated as complete response (CR; complete disap-
pearance of the lesions in the treatment area), partial response
(PR; reduction of ≥ 50% in the number of clinically visible AK)
or non-response.
doi: 10.2340/00015555-2607
Acta Derm Venereol 2017; 97: 646–648
RCM images of the areas selected at baseline were captured
with a commercially available hand-held device (VivaScope 1500;
Lucid-Tech, Inc., Henrietta, NY, USA). RCM images 6 × 6 mm
were obtained horizontally from the lesion using the VivaBlock
function modality. Vertical mapping using the VivaStack was
performed at intervals of 5 μm up to a depth of 200 μm, begin-
ning with the stratum corneum (SC ) through the entire epidermis
and into the superficial dermis. Based on previous AK diagnostic
criteria, the study areas were evaluated for the presence or absence
of the following RCM features of AK: hyperkeratosis, parakera-
tosis, disruption of the SC (irregular cornea), overall architectural
disruption (atypical honeycomb pattern, architectural disarray, and
irregular epidermal pattern), blood vessel dilatation, inflammatory
infiltrate, and solar elastosis.
RESULTS
Of the 17 patients initially recruited into the study, 15
had follow-up data until week 4, and 12 patients finalized
the study with evaluation at week 8. Demographic and
clinical characteristics of patients, including AK clinical
severity (Olsen grade) and RCM parameters at baseline
are summarized in Table SI 1 .
The therapeutic outcome at week 8 was evaluated
clinically as CR in 7/12 (58%) patients and PR in 4/12
patients (33%). Only one patient was classified as a
non-responder.
To detect morphological changes following topical
applications of IM, RCM evaluations of AK were per-
formed at baseline and at weeks 4 and 8 after treatment.
Disarranged epidermal pattern was identified in all pa-
tients before initiation of treatment. Disruption of SC and
hyperkeratosis were seen in 14/15 patients. A decreasing
frequency of these abnormal features and parakeratosis
was observed at week 4, especially in the number of
patients with hyperkeratosis and disruption of the SC
(identified in only 3 patients, respectively). Overall, these
https://www.medicaljournals.se/acta/content/abstract/10.2340/00015555-2607
1
Table I. Reflectance confocal microscopy (RCM) findings before
treatment, and 4 and 8 weeks after treatment
Feature on RCM Before
treatment
(n=15)
n (%) 4 weeks after
treatment
(n=15)
n (%) 8 weeks after
treatment
(n=12)
n (%)
Hyperkeratosis
Parakeratosis
Disruption of the stratum corneum
Disarranged epidermal pattern
Solar elastosis
Inflammatory infiltrate
Blood vessel dilatation 14 (93)
9 (60)
14 (93)
15 (100)
12 (80)
11 (73)
9 (60) 3 (20)
1 (7)
3 (20)
7 (47)
12 (80)
11 (73)
9 (60) 1
1
2
5
8
6
7
(8)
(8)
(17)
(42)
(67)
(50)
(58)
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Journal Compilation © 2017 Acta Dermato-Venereologica.