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

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ClinicalTrials.gov Identifier: NCT01591993
Recruitment Status : Completed
First Posted : May 4, 2012
Last Update Posted : November 29, 2012
Sponsor:
Collaborator:
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by (Responsible Party):
Juan Pablo Castanedo Cazares, Universidad Autonoma de San Luis Potosí

Tracking Information
First Submitted Date  ICMJE April 27, 2012
First Posted Date  ICMJE May 4, 2012
Last Update Posted Date November 29, 2012
Study Start Date  ICMJE October 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
Sensitivity to lactic acid [ Time Frame: 10 minutes ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01591993 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • Erythema [ Time Frame: 0, 3, 5, 8 and 10 minutes ]
    Measure the presence of erythema through colorimetry (a* axis).
  • Skin pigmentation [ Time Frame: 0 minutes ]
    Measure the melanin angle (through L* axis) before performing the test.
  • Transepidermal water loss [ Time Frame: 0, 3, 5, 8 and 10 minutes ]
    Quantify the change in TEWL by evaporimetry in grams per squared meter per hour, as an indirect measure of skin barrier disfunction.
  • Capacitance [ Time Frame: 0, 3, 5, 8, 10 minutes ]
    Quantify the change in capacitance by corneometry, as an indirect measure of skin barrier disfunction.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of Sensitive Skin and Its Biophysical Response in a Latin-American Population
Official Title  ICMJE Determination of Sensitive Skin in a Mexican Population by Lactic Acid Testing and Its Analysis Through Biophysical Measures
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Skin Irritancy Tests
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Test subject
    To each subject, the investigators will randomly apply 10% lactic acid on one nasolabial fold, once.
    Intervention: Procedure: 10% lactic acid test
  • Placebo Comparator: Placebo
    To each subject, the investigators will apply placebo (0.9% saline solution) on the contralateral nasolabial fold to the lactic acid, simultaneously.
    Intervention: Procedure: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2012)
260
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2012)
200
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01591993
Other Study ID Numbers  ICMJE SenSk12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juan Pablo Castanedo Cazares, Universidad Autonoma de San Luis Potosí
Study Sponsor  ICMJE Universidad Autonoma de San Luis Potosí
Collaborators  ICMJE Hospital Central "Dr. Ignacio Morones Prieto"
Investigators  ICMJE
Principal Investigator: Diana V Hernández-Blanco, MD Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Principal Investigator: Adriana Ehnis-Pérez, MD Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Study Director: Juan P Castanedo-Cázares, MD Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Study Chair: Bertha Torres-Álvarez, MD Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
PRS Account Universidad Autonoma de San Luis Potosí
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP