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

Primary Purpose

Skin Irritancy Tests

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
10% lactic acid test
Placebo
Sponsored by
Universidad Autonoma de San Luis Potosí
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Skin Irritancy Tests focused on measuring Sensitive skin, Lactic acid test, Transepidermal water loss, Colorimetry, Capacitance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers
  • Informed consent

Exclusion Criteria:

  • Pregnancy
  • Known allergy to lactic acid
  • Presence of any dermatoses in the nasolabial folds
  • Topical o systemic drugs in the previous 4 weeks

Sites / Locations

  • Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test subject

Placebo

Arm Description

To each subject, the investigators will randomly apply 10% lactic acid on one nasolabial fold, once.

To each subject, the investigators will apply placebo (0.9% saline solution) on the contralateral nasolabial fold to the lactic acid, simultaneously.

Outcomes

Primary Outcome Measures

Sensitivity to lactic acid
Identify and measure the presence of any unpleasant sensation after the application of 10% lactic acid test to the nasolabial fold. Will serve to identify subjects with sensitive skin.

Secondary Outcome Measures

Erythema
Measure the presence of erythema through colorimetry (a* axis).
Skin pigmentation
Measure the melanin angle (through L* axis) before performing the test.
Transepidermal water loss
Quantify the change in TEWL by evaporimetry in grams per squared meter per hour, as an indirect measure of skin barrier disfunction.
Capacitance
Quantify the change in capacitance by corneometry, as an indirect measure of skin barrier disfunction.

Full Information

First Posted
April 27, 2012
Last Updated
November 28, 2012
Sponsor
Universidad Autonoma de San Luis Potosí
Collaborators
Hospital Central "Dr. Ignacio Morones Prieto"
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1. Study Identification

Unique Protocol Identification Number
NCT01591993
Brief Title
Determination of Sensitive Skin and Its Biophysical Response in a Latin-American Population
Official Title
Determination of Sensitive Skin in a Mexican Population by Lactic Acid Testing and Its Analysis Through Biophysical Measures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de San Luis Potosí
Collaborators
Hospital Central "Dr. Ignacio Morones Prieto"

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Sensitive skin is defined as the presence of itching, stinging, burning or other unpleasant sensations due to external factors (such as light, heat, cold, air, cosmetic products, soap, water and even emotional and hormonal factors). By definition it is a subjective syndrome, where there are no clinical signs, making it a self-diagnosed entity. Previous community-based studies, mostly in caucasians, have found a high prevalence in general population. Nonetheless, to date there are only a few studies and with a small amount of subjects that have applied an objective test to identify this syndrome, and even fewer have explored the possible alterations associated to it. The investigators aim to describe the frequency in a hispanic population, and further explore the presence of alterations in the barrier function through measurement of TEWL and capacitance, as well as possible subclinical erythema (a* axis of colorimetry) or variations due to skin pigmentation (L* axis). The volunteers in the study will be randomized to receive in one nasolabial fold 10% lactic acid solution, and placebo (0.9% saline solution) in the other to act as the control. The investigators will be grading any unpleasant sensation in a 10-point scale (VAS) at 4 different time intervals: 3, 5, 8 and 10 minutes. The investigators will be measuring colorimetry (ChromaMeter CR-300 (Minolta, Japan)), TEWL (Evaporimeter DermaLab (Cortex Technology, Denmark)) and capacitance (Corneometer DermaLab Moisture Module (Cortex Technology, Denmark)) before performing the test, and at 3, 5, 8 and 10 minutes after it. These time intervals have been previously determined according to previous reports where the maximum intensity of the response is obtained in the first 5 minutes, and after 10 minutes the response gradually diminishes. Statistical analysis will be performed with square chi test, t-test or U-Mann-Whitney, according to the parametric or non-parametric distribution of the values. All tests will be performed using the JMP software 8.0 (Cary, NC, USA) at 95% of confidence, statistical significance at 5% with 80% power.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Irritancy Tests
Keywords
Sensitive skin, Lactic acid test, Transepidermal water loss, Colorimetry, Capacitance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test subject
Arm Type
Experimental
Arm Description
To each subject, the investigators will randomly apply 10% lactic acid on one nasolabial fold, once.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
To each subject, the investigators will apply placebo (0.9% saline solution) on the contralateral nasolabial fold to the lactic acid, simultaneously.
Intervention Type
Procedure
Intervention Name(s)
10% lactic acid test
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity to lactic acid
Description
Identify and measure the presence of any unpleasant sensation after the application of 10% lactic acid test to the nasolabial fold. Will serve to identify subjects with sensitive skin.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Erythema
Description
Measure the presence of erythema through colorimetry (a* axis).
Time Frame
0, 3, 5, 8 and 10 minutes
Title
Skin pigmentation
Description
Measure the melanin angle (through L* axis) before performing the test.
Time Frame
0 minutes
Title
Transepidermal water loss
Description
Quantify the change in TEWL by evaporimetry in grams per squared meter per hour, as an indirect measure of skin barrier disfunction.
Time Frame
0, 3, 5, 8 and 10 minutes
Title
Capacitance
Description
Quantify the change in capacitance by corneometry, as an indirect measure of skin barrier disfunction.
Time Frame
0, 3, 5, 8, 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Informed consent Exclusion Criteria: Pregnancy Known allergy to lactic acid Presence of any dermatoses in the nasolabial folds Topical o systemic drugs in the previous 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana V Hernández-Blanco, MD
Organizational Affiliation
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adriana Ehnis-Pérez, MD
Organizational Affiliation
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan P Castanedo-Cázares, MD
Organizational Affiliation
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bertha Torres-Álvarez, MD
Organizational Affiliation
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Official's Role
Study Chair
Facility Information:
Facility Name
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
City
San Luis Potosí
ZIP/Postal Code
78210
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
9687028
Citation
Seidenari S, Francomano M, Mantovani L. Baseline biophysical parameters in subjects with sensitive skin. Contact Dermatitis. 1998 Jun;38(6):311-5. doi: 10.1111/j.1600-0536.1998.tb05764.x.
Results Reference
background
PubMed Identifier
9145266
Citation
Issachar N, Gall Y, Borell MT, Poelman MC. pH measurements during lactic acid stinging test in normal and sensitive skin. Contact Dermatitis. 1997 Mar;36(3):152-5. doi: 10.1111/j.1600-0536.1997.tb00399.x.
Results Reference
background
PubMed Identifier
18492170
Citation
Sparavigna A, Di Pietro A, Setaro M. 'Healthy skin': significance and results of an Italian study on healthy population with particular regard to 'sensitive' skin. Int J Cosmet Sci. 2005 Dec;27(6):327-31. doi: 10.1111/j.1467-2494.2005.00287.x.
Results Reference
background

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

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