Clinical Trials Directory

Trials / Completed

CompletedNCT02603029

Influence of of Cream With the Silver Fir Wood Extract (Belinal) on Skin

Placebo Controlled Study of Influence of Cream With the Silver Fir (Abies Alba) Wood Extract on the Skin

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
VIST - Faculty of Applied Sciences · Academic / Other
Sex
Female
Age
45 Years – 60 Years
Healthy volunteers
Accepted

Summary

Objective of the study is to determine the influence of the cream with Silver fir wood (Abies alba) extract (Belinal) on the skin parameters and functions in comparison to the placebo cream. 10 healthy female subjects will use the test cream on one half and placebo cream on the other half of the face and of the gluteal part twice a day for 12 weeks. Various face skin parameters will be evaluated before the cream use (the baseline), after 6 and after 12 weeks of the cream use. To evaluate the photoprotective potential of Belinal the minimal erythema dose (MED) will be determined before (the baseline) and after 12 weeks of the cream use at the gluteal area.

Detailed description

Objective of the study is to determine the influence of the cream with Silver fir wood (Abies alba) extract (Belinal; 2% cream) on the skin parameters and functions in comparison to the placebo cream. 10 healthy female subjects will use the test cream on one half and placebo cream on the other half of the face and of the gluteal area (split-face and split-gluteal area ) twice a day for 12 weeks. Face skin parameters will be evaluated before the cream use (the baseline), after 6 and after 12 weeks of the cream use. The photoprotective potential of Belinal will be evaluated with a determination of the minimal erythema dose (MED) at the gluteal area before (the baseline) and after 12 weeks of the cream use. Comparison will be done as the mean of the individual ratios. The differences between the before-after condition will be analyzed with the statistical test of analysis of variance. In case of failure to find homogeneity in the variances the nonparametric ANOVA, the Willcoxon test, will be used. The results will be expressed as mean ± standard error for each group with a significance level of 0.05 for all the statistical tests.

Conditions

Interventions

TypeNameDescription
OTHERPlacebo creamSubjects will use placebo cream twice per day for 12 weeks on one half of the face and of the gluteal area.
OTHERBelinal creamSubjects will use Belinal cream twice per day for 12 weeks on the other half of the face and of the gluteal area.

Timeline

Start date
2015-03-01
Primary completion
2015-07-01
Completion
2015-07-01
First posted
2015-11-11
Last updated
2016-03-08

Source: ClinicalTrials.gov record NCT02603029. Inclusion in this directory is not an endorsement.