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

NCT01591993 | Completed Phase 4

• 1 other identifier: SenSk12
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Irritancy Tests

Keywords

Sensitive skin; Lactic acid test; Transepidermal water loss; Colorimetry; Capacitance

Outcome Measures

Primary Outcomes (1)

• 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.

  10 minutes

Secondary Outcomes (4)

• Erythema

  0, 3, 5, 8 and 10 minutes

• Skin pigmentation

  0 minutes

• Transepidermal water loss

  0, 3, 5, 8 and 10 minutes

• Capacitance

  0, 3, 5, 8, 10 minutes

Study Arms (2)

Test subject

EXPERIMENTAL

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

Procedure: 10% lactic acid test

Placebo

PLACEBO COMPARATOR

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

Procedure: Placebo

Interventions

10% lactic acid test PROCEDURE

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.

Test subject

Placebo PROCEDURE

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Autonoma de San Luis Potosí: lead
• Hospital Central "Dr. Ignacio Morones Prieto": collaborator

Study Sites (1)

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

San Luis Potosí City, San Luis Potosí, 78210, Mexico

Location

Related Publications (3)

• 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.

  PMID: 9687028 BACKGROUND

• 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.

  PMID: 9145266 BACKGROUND

• 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.

  PMID: 18492170 BACKGROUND

Study Officials

• 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"

  PRINCIPAL INVESTIGATOR

• Juan P Castanedo-Cázares, MD

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

  STUDY DIRECTOR

• Bertha Torres-Álvarez, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Research Director

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 4, 2012
• Study Start: October 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

ME (1)