At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Determination of Sensitive Skin in a Mexican Population by Lactic Acid Testing and Its Analysis Through Biophysical Measures
In Brief
A Phase 4 clinical trial evaluating 10% lactic acid test and Placebo for Skin Irritancy Tests. Completed, enrolled 260 participants across 1 site.
Detailed Summary
Sensitive skin syndrome is a frequent self-diagnosed entity that has not been previously described in a Latin-american population. One hypothesis to its development is an alteration of the barrier function of the skin. The aim of the study is to describe the frequency of sensitive skin in a mexican population detected through the lactic acid test, and to explore its response through biophysical measures (colorimetry, transepidermal water loss (TEWL) and capacitance). The prevalence of this syndrome in studied populations is approximately 50%. Considering racial skin differences, the investigators would expect at least a 20% prevalence. For this purpose, the investigators would need a minimum of 243 healthy volunteers, 18 years or older, with previous informed consent, to whom the lactic acid test will be performed. The investigators will record any unpleasant sensation graded in a Visual Analog Scale (VAS) of 10 points, colorimetry, TEWL and capacitance before the test and at 3, 5, 8 and 10 minutes after the lactic acid test.
Study Details
Timeline
Interventions
To each subject, 10% lactic acid is applied to one nasolabial fold. This will be performed under humidity, temperature and pH control to avoid influence of these variables in the result of the test.
To each subject, 0.9% saline solution will be applied to the contralateral nasolabial fold. This will be performed under humidity, temperature and pH control to avoid influence of these variables in the result of the test.