A Phase 3 interventional study of Emulsion and gel in Healthy, sponsored by Derming SRL. Completed at 1 site in Italy. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-30.
Sponsored by Derming SRL · Phase 3, Interventional, and Treatment
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):
At the end of the study (T8), each volunteer filled a questionnaire regarding:
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.
Derming SRL is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Skin spots image analysis: change from baseline (T2, T4 and T8 vs. T0)
Skin spots area was measured on the pre-selected images performed with or without Wood's lamp. The measure of skin spots area was performed by means of an image analysis software, with a function called "magic wand". Based on the colour similarities or on the difference of intensity ranges between the selected pixels (with a specified tolerance interval) the magic wand automatically traced the outline of the spot and measured the selected area (pixel2).
Time frame: after 2, 4 and 8-week-treatment
Spectrophotometric evaluation: change from baseline (T2, T4 and T8 vs. T0)
Skin brightness was measured by a visible-UV-IR (λ from 300 to 900 nm) spectrophotometer which uses a tungsten halogen lamp and a deuterium lamp in accordance with CIE (Commission Internationale de l'Eclarage), the main international organisation concerned with colour and colour measurement. Lamps were switched on 30 minutes before instrument use in order to join a stable emission. Measurement angle was 90° (position of the probe on the skin) and measured area was 2 mm2; used wavelength range was 380-780 nm corresponds to the visible light spectrum.
Time frame: after 2, 4 and 8-week-treatment
Optical colorimetry: change from baseline (T2, T4 and T8 vs. T0)
Measurement of spots colour were performed by a tri-stimulus colorimeter equipped with three special filters to obtain R,G,B values in accordance with CIE (Commission Internationale de l'Eclarage), the main international organisation concerned with colour and colour measurement. CIE L\*a\*b\* system (CIELAB) is the most complete colour-space specified by the CIE (1976). It describes all the colours visible to the human eye; the three coordinates of L\*a\*b\* represent the lightness of the colour (L\* = 0 yields black and L\* = 100 indicates diffuse white; specular white may be higher), its position between red/magenta and green (a\*, negative values indicate green while positive values indicate magenta) and its position between yellow and blue (b\*, negative values indicate blue and positive values indicate yellow).
Time frame: after 2, 4 and 8 week-treatment
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Derming SRL