Improvement of psoriatic onychodystrophy by a water

Volume 23 Number 7 July 2009
Reprinted Article
Improvement of psoriatic onychodystrophy by a
water-soluble nail lacquer
F Cantoresi,* P Sorgi, A Arcese, A Bidoli, F Bruni,
C Carnevale, S Calvieri
Department of Dermatology, ‘La Sapienza’ University, Rome, Italy
*
Correspondence: F Cantoresi. E-mail: [email protected]
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ACADEMY
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DERMATOLOGY
DERMATOLOGY
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VENEREOLOGY
VENEREOLOGY
(www.eadv.org)
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JEADV
DOI: 10.1111/j.1468-3083.2009.03209.x
SHORT REPORT
Blackwell Publishing Ltd
Improvement of psoriatic onychodystrophy by a water-soluble nail
lacquer
F Cantoresi,* P Sorgi, A Arcese, A Bidoli, F Bruni, C Carnevale, S Calvieri
Department of Dermatology, ‘La Sapienza’ University, Rome, Italy
*Correspondence: F Cantoresi. E-mail: [email protected]
Abstract
Background There is a strong need for effective products, simple to use and safe for a chronic use in the management
of nail psoriasis. Recently, a non-drug, water-soluble nail lacquer became available, containing hydroxypropyl chitosan
(HPCH), horsetail extract (Equisetum arvense) and methylsulphonyl-methane (DMSO2). This product was effective in
strengthening the nails and reducing fragility and roughness in brittle nails. A clinical trial was performed to verify whether
this product was able to improve nail psoriatic signs and appearance.
Patients and methods Thirty adult patients affected by mild to moderate symmetric psoriasis of the matrix and/or of
the nail bed in at least one fingernail diagnosed more than 6 months before screening and with negative mycology
findings were recruited. The nail lacquer was applied once daily on the affected fingernails of the left hand for 24
consecutive weeks. The right hand was used as control. The extent and severity of nail psoriasis was assessed on a target
fingernail by means of the recently proposed Nail Psoriasis Severity Index (NAPSI) score. The value at baseline was 2.83
(± 0.99). At the end of treatment, the patients judged the treatment effect and their willing to continue product application.
Adverse events were carefully recorded.
Results Overall, 28 patients were included in the efficacy analysis. At the end of treatment, results showed a 72%
reduction in pitting, 66% reduction in leukonychia, 63% reduction in onycholysis and a reduction of 65% in NAPSI score
compared to baseline, respectively. No changes were observed in the untreated nails.
Patients’ treatment evaluation was classified as very satisfying or good by 78.6% of patients.
The acceptability of the treatment was excellent in all patients both for the easiness and for the organoleptic
characteristics of the product and 75% of them decided to continue the application after the end of the study.
No adverse reactions were reported.
Conclusion In our experience, the new water-soluble nail lacquer proved to be effective in decreasing signs and
symptoms of nail dystrophy in psoriatic patients. The effect was particularly evident on NAPSI and on pitting. The product
was very well accepted by the patients.
Received: March 2006; Accepted June 2006
Keywords
hydroxypropyl-chitosan (HPCH), nail lacquer, Nail Psoriasis Severity Index (NAPSI), psoriatic onychodystrophy
Conflict of Interest
None declared.
Introduction
Nail abnormalities are evident in up to 50% of patients with
skin psoriasis and may be the first manifestation of the disease
in the whole body. The disease can also be limited to the nails,
by affecting few or several nails. Diagnostic signs include
irregular pitting, salmon patches of the nail bed and
onycholysis with erythematous borders. Nail psoriasis may
produce also non-specific nail signs such as splinter haemorrhages, nail bed hyperkeratosis, nail thickening, crumbling and
leukonychia.1
JEADV 2009, 23, 832–834
In most of the patients, nail abnormalities due to psoriasis cause
pain and restrictions in daily activities and an improvement in
their quality of life is often more important than an objective
clinical improvement.2,6
Nail psoriasis is usually difficult to treat due to different factors:
the slow growth rate of the nail plate, the difficulty of the topical
treatments to penetrate through the nail plate and the long-term
treatment necessary for obtaining any clinical benefit. Moreover,
the potential toxicity of systemic drugs limits the treatment to
patients with extensive disease.3
© 2009 The Authors
Journal compilation © 2009 European Academy of Dermatology and Venereology
Efficacy of new nail-lacquer
Thus, there is a strong unsatisfied need for new effective therapeutic
agents, simple to use and safe enough to allow chronic use by patients.
The limitation of the topical available treatment (such as
calcipotriol, tazarotene and steroids) is that usually they must be
applied under an occlusive medication, which is bothersome,
time-consuming and applicable only at night. Triamcinolone
acetonide could also be injected into the proximal or/and lateral
psoriatic nail fold.
Oral treatments such as low dosages of acitretin, methotrexate,
cyclosporin A and the new biological agents (infliximab and
alefacept) should only be used when nail psoriasis is associated
with widespread disease or psoriatic arthritis.
Recently, a new medical device became available on the market,
consisting in a non-drug, water-soluble nail lacquer containing
hydroxypropyl chitosan (HPCH), which forms a film after application on the nail surface and evaporation of the solvent. Previous
clinical investigations4 put in evidence the properties of the
product, and its effectiveness in the management of nail splitting
and nail brittleness when regularly applied on damaged nails. As
the manifestations of psoriasis in the nails are mostly due to
dystrophy of the nail lamina, which renders the nail soft and
fragile, a clinical trial was performed to verify whether the
strengthening and hardening properties of the HPCH nail lacquer
could improve the structure and the appearance of the nail plates
after regular application on psoriatic nails.
833
Figure 1 NAPSI score and clinical signs in target nails pre- and
post-treatment (data are means ± SEM).
Results
from 0.97 ± 1.10, 0.29 ± 0.60 and 0.54 ± 0.88 at baseline to
0.27 ± 0.64, 0.10 ± 0.31 and 0.20 ± 0.66 at the end of treatment,
respectively. The percent reduction from baseline to end of
treatment was 72% for pitting, 66% for leukonychia and 63% for
onycholysis.
The global clinical evaluation by the Investigator highlighted
that clinical effects started to be evident at the 12-week examination, being evaluated as ‘good’ in 14 patients (50%). At the end of
treatment (24 weeks), the judgement was ‘very satisfying’ and
‘good’ in 22 patients (78.5%).
The evaluation of treatment by the patients was very satisfying
or good in 22 patients (78.6%) by the end of study.
Individual cases referred to the end of treatment are documented
in the pictures presented in Figs 2–4.
The acceptability of the treatment was excellent in all patients
both for the treatment easiness and for the organoleptic
characteristics of the product, and 21 (75%) of them decided to
continue the application after the study end.
The tolerability of the treatment was good in all patients and no
adverse reactions were reported.
Overall 30 patients (20 female and 10 male) aged between 18 and
75 years (mean ± SD, 44.83 ± 16.78), affected by mild to moderate
nail psoriasis in two to five fingernails of both hands (mean,
2.57 ± 0.74), were enrolled. The efficacy analysis was performed in
28 patients being two patients lost to follow-up after the baseline visit.
The NAPSI score decreased from 2.83 ± 0.99 at baseline to 1.00
± 1.22 after 24 weeks of treatment. The data are summarized in
Fig. 1. The pitting, leukonychia and onycholysis score decreased
Nail psoriasis is difficult to treat because systemic treatments
should only be used in moderate to severe cases and topical
treatments are not yet available in formulations suitable for long
lasting contact with the nail lamina and mostly require occlusive
medication, which is bothersome for the patients and suitable
only during the night time.
Patients and methods
Thirty adult patients affected by mild to moderate symmetric nail
psoriasis of the matrix and/or of the nail bed in at least one
fingernail diagnosed more than 6 months before screening and
with negative mycology findings were recruited. The patients
were assessed by the Investigator every 4 weeks for clinical signs
namely pitting, onycholysis and/or leuchonychia and for the
extent and severity of nail psoriasis on the target fingernail, by
means of the Nail Psoriasis Severity Index (NAPSI) score.5 The
NAPSI score at the baseline visit was 2.83 ± 0.99. The nail lacquer
was applied once daily on the affected fingernails of the left hand
for 24 consecutive weeks. The right hand was used as control. At
the end of treatment, the patients judged the treatment effect
and their willing to continue product application. Adverse events
were carefully recorded. The data were processed by means of a
descriptive analysis on the intention-to-treat population.
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Discussion
© 2009 The Authors
Journal compilation © 2009 European Academy of Dermatology and Venereology
Cantoresi et al.
834
Figure 2 Improvement of pitting and salmon patch resolved in the
treated (left) index fingernail nail after 24 treatment weeks,
compared to the untreated right index fingernail.
Figure 4 Onycholysis and salmon patch completely resolved, but
pitting still evident in the treated (left) index fingernail after 24
treatment weeks, compared to the untreated right index fingernail.
After a visual inspection, the effect was particularly evident on
pitting and on nail fragility as reported by the patients.
HPCH is the film forming agent and allows a long lasting
adherence to the nail surface, by penetrating into the unevenness
and holes of the nail structure thus decreasing keratin desquamation.
Moreover, the nail lacquer is endowed by emollient properties,
which may be useful in the local treatment of the psoriatic lesions.
Nail psoriasis is often precipitated and worsened by microtraumas
due to Koebner phenomenon,1 and if the nail plate is strengthened
and protected, this might be reduced.
Figure 3 Pitting almost completely resolved in the treated (left)
index fingernail after 24 treatment weeks, compared to the
untreated right index fingernail.
1 de Berker D, Baran R, Dawber R. The nail in dermatological disease. In:
Baran & Dawber’s. Diseases of the Nails and Their Management, ch. 5, 3rd
edn., Blackwell Science, 2001.
2 de Jong EM, Seeger BA, Gulinck MK et al. Psoriasis of the nails associated
with disability in a large number of patients: results of a recent interview with
1728 patients. Dermatology 1996; 193: 300–303.
3 de Berker D. Management of nail psoriasis. Clin Exp Dermatol 2000; 25:
357–362.
4 Sparavigna A, Setaro M, Genet M et al. Equisetum arvense in a new
transungual technology improves nail structure and appearance. J Plastic
Dermatol 2006; 2: 31–38.
5 Rich P, Scher RK. Nail Psoriasis Severity Index: a useful tool for evaluation of
nail psoriasis. J Am Acad Dermatol 2003; 49: 206–212.
6 Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)
– a simple practical measure for routine clinical use. Clin Exp Derm 1994; 19:
210–216.
BB 07/2009/048
A hardening and strengthening effect of the new medical device
consisting in a HPCH nail lacquer had been previously reported5
in subjects with nail splitting and nail brittleness when regularly
applied on damaged nails. In our experience the new HPCH nail
lacquer provided a relevant improvement of the nail structure of
psoriatic patients affected by onychodystrophy. In particular, the
effect was particular evident on the nail psoriatic clinical signs
such as pitting, leukonychia and onycholysis as shown by the
pictures taken throughout the study.
References
JEADV 2009, 23, 832–834
© 2009 The Authors
Journal compilation © 2009 European Academy of Dermatology and Venereology