NCT02204436

Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Derming SRL · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Emulsion and gel	A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2014-07-30
• Last updated: 2014-07-30

Locations

1 site across 1 country: Italy