Determination of Sensitive Skin and Its Biophysical Response in a Latin-American Population

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.

Conditions

• Skin Irritancy Tests

Interventions

PROCEDURE

10% lactic acid test

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.

PROCEDURE

Placebo

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.

Sponsors & Collaborators

• Hospital Central "Dr. Ignacio Morones Prieto"

  collaborator OTHER

• Universidad Autonoma de San Luis Potosí

  lead OTHER

Principal Investigators

• Diana V Hernández-Blanco, MD · Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

• Adriana Ehnis-Pérez, MD · Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

• Juan P Castanedo-Cázares, MD · Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

• Bertha Torres-Álvarez, MD · Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2012-05-31

Completion

2012-08-31

Countries

• Mexico

Study Locations