Healthy Clinical Trial
Official title:
Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin
Aim of the study was to evaluate by instrumental measurements the depigmenting activity of a
cosmetic treatment for spotted hand skin; in particular it was investigated the synergic
activity of an emulsion, with clarifying-antioxidant activity combined with an activator
gel, with hydration and keratolytic activity.
Female healthy volunteers aged 45-65 years old, presenting senile lentigo on the hands, were
included in the study.
It was also aim of this study to evaluate treatment efficacy and cosmetic acceptability by
the volunteers and tolerance both by investigator and volunteers.
The following instrumental evaluations were performed in basal conditions (T0 - before
product use), after 4 (T4) and 8 week-treatment (T8):
- Image analysis with UV flash (Wood's light)
- Photographic recovery
- Skin spots image analysis
- Skin colour evaluation
- Spectrophotometry (skin brightness)
- Optical colorimetry (spots colour)
At the end of the study (T8), each volunteer filled a questionnaire regarding:
- the efficacy of the study product (skin brightness and hydration, spots dimensions and
colour intensity - score: very marked; marked; medium; light; absent)
- the cosmetic acceptability of the study product: colour and perfume before and after
application, consistency, spreadability, absorption, effect on the skin, greasiness and
presence of product residues (score: negative; medium; good; excellent) the product
tolerance (score: bad; poor; medium; good; excellent).
At the end of the study the investigator assessed the treatment tolerance considering the
possible appearance of related adverse events as bad, poor, medium, good, excellent.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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