Aprile Vol.2 N° 1 - 2006 - Salute per tutti

hardens and strengthens the nail (6). Hydroxypropyl
Chitosan (HPCH) improves nail hydration
and is an excellent carrier of actives (7); the
sulfur donor improves quality and supports nail
growth (8).
Aim of the study was to assess the efficacy of this
new topical formulation in improving nail splitting/fragility
by means of two separate investigations
in women.
M ethods
First study
The study included women with nail
alterations namely lamellar splitting caused by
pathologic process (mycosis, psoriasis or bacterial
infection) or exogenous causes (trauma,
chemical agents or humidity) who had signed an
informed consent form.
Overall, 36 women were enrolled, 41% office
workers, 27% housewives, 8% manual workers,
6% dressmakers, 5.5% nurses, 5.5% students,
7% other.
Every night, the subjects applied the test
productA on the surface of the nails of one randomly
assigned hand for 28 days. The subjects
were advised not to wash hands for the following
6 hours. The nails of the other hand were
evaluated as control nails.
Casts (silicon replica) of nail lamina were taken
on days 0, 14, 28 from the thumb of both hands
(after removal of the product by washing) and
subjected to computerized image analysis (9)
(optical profilometry) in order to evaluate the
regularity of the nail surface at baseline and any
change due to the treatment. Silicon replicas
were taken in standard conditions in order to
reproduce them at any time.
Pictures of silicon replicas at a light angle of 45°
revealed shadows on the replica (which is the
negative image of longitudinal and transverse
grooves in the nail lamina). These shadows were
transformed into a grey scale whose intensity
was proportional to the intensity of the shadows
and therefore to the depth of the grooves. The
surface of the replica underwent a scanning procedure
highlighting any alterations in the longitudinal
and transverse grooves (Beau lines) in
the nail. The scans were taken almost at the centre
of basal replica, and always at the same level
but not at the same preceding height (since the
nail plate was grown) for the following observations
times. The precision in the measurement is
Equisetum arvense in a new transungual technology improves nail structure and appearance
obtained by observing thoroughly the morphology
of the nail plate and by identifying precise
traces to be used as reference.
The mean roughness (Ra) was calculated as the
arithmetical mean of all deviations in absolute
value.
The parameters evaluated on days 0, 14, 28 were
clinical assessment of the nails treated including
the classification of the damage (dystrophy, onycholysis,
splitting and fragility) and the causative
factors. The degree of the damage was assessed
on the basis of the following score scale:
0 = absent, 1/2 = slight, 1 = moderate, 2 = severe.
Statistical analysis was performed by measuring
the significance of differences between groups
(treated vs untreated) and between times (intermediate
vs baseline and final vs baseline) by
means of Student’s t test for roughness, and of
Wilcoxon test for clinical parameters.
Moreover, the subject’s acceptability of the test
product was investigated. Each subject
expressed a 4-points score on different items
referred to the product (appearance, tactile sensation,
feeling on and after application, tolerability
and efficacy).
Second study
The study included women with nail
alterations (dystrophy, onycholysis, splitting and
fragility) due to pathological or exogenous causes,
who had signed an informed consent form.
Overall, 22 women were enrolled, 50% housewives,
18% office workers, 9% manual workers,
5% nurses, 9% students, 9% other.
The aim of this study was to evaluate the protective
activity of the test product with respect to a
common cosmetic nail varnish applied for 2
weeks on the treated and control nails.
Every night, the subjects applied, on alternative
days, the test product B on the surface of the nails
of one hand randomly assigned for 2 weeks. The
nails of the other hand were evaluated as control
nails. After product absorption, the subject
applied a common cosmetic nail varnish, provided
by the Investigator, to the nails of both
hands. Before each new test product application,
the common nail varnish was removed in all
nails by means of a standard solvent provided by
the Investigator.
Clinical and instrumental assessments for evaluation
of nail alterations were performed at baseline,
on day 7 and on day 14 (final visit). Casts
(silicon replicas) of nail surfaces of the thumb
treated and untreated were subjected to
A. Extract of E. arvense, Methyonine, HPCH and other ingredients, patented by Polichem SA, Lugano (Switzerland);
B. Ecocel
Journal of Plastic Dermatology 2006; 2, 1 33
® patented by Polichem SA, Lugano (Switzerland). Same composition as per the first study, with the exception of sulfur donor:
methylsulfonyl methane (MSM) instead of methyonine.