TRPV Expression in Subjects With Sensitive Skin

NCT01871883 | Unknown Phase 4

• 1 other identifier: TRPV1SenSk
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Sensitive skin syndrome is defined as the presence of burning, itching or any other unpleasant sensation on the skin, due to physical, chemical or psychological factors. It is frequently a self-diagnosed condition, and there are no accurate tests to recognize or quantify it because of the individual variations in perception and intensity of the related symptoms. The most accepted physiopathogenic theory is the presence of an altered barrier function of epidermis. Also, changes in the pH of the stratum corneum have been found to induce skin sensitivity through the activation of the transient potential receptor vanilloid (TRPV) neuronal receptors. TRPV1 has been found in human keratinocytes, although its physiologic role in the skin is not yet established. Their presence in keratinocytes and cutaneous nervous fibers suggests a role in the sensitive function of the epidermis. Since this receptors can be activated by low pH (\< 5.9), which is also important for the development of sensitive skin, we hypothesized that an increase in the expression of these receptors can be the responsible for the syndrome.

Conditions

Sensitive Skin

Keywords

Sensitive skin; Transient potential receptor vanilloid 1; TRPV1; Transepidermal water loss; Skin Phototype; Lactic acid test; Skin irritancy tests

Outcome Measures

Primary Outcomes (1)

• Expression of TRPV1

  Determine the expression of TRPV1 in patients with sensitive skin

  Up to 1 year

Secondary Outcomes (3)

• TRPV1 and Sensitive Skin

  Up to 1 year

• TRPV1 and skin phototype

  Up to 1 year

• TRPV1 and barrier function

  Up to 1 year

Other Outcomes (4)

• TRPV1 mRNA in biopsies

  Up to 1 year

• TRPV1 in biopsies by immunohistochemistry

  Up to 1 year

• mRNA1 of TRPV1 in oral keratinocytes

  Up to 1 year

Study Arms (2)

Sensitive Skin

EXPERIMENTAL

Subjects with sensitive skin, diagnosed by the lactic acid stinging test. Skin biopsy Oral mucosa specimen

Procedure: Skin biopsy; Procedure: Oral mucosa specimen

Non-sensitive skin

ACTIVE COMPARATOR

Subjects without sensitive skin, determined by a negative lactic acid stinging test Skin biopsy Oral mucosa specimen

Procedure: Skin biopsy; Procedure: Oral mucosa specimen

Interventions

Skin biopsy PROCEDURE

Two skin biopsies will be taken with a 3 mm punch in the retroauricular area. The procedure will be done by an investigator, under aseptic and antiseptic conditions and under local anesthesia with lidocaine and epinephrine. The incision will be sutured with 6-0 Nylon, and the stitches will be removed after 5 days. One biopsy will be processed for immunohistochemistry, the other for RNA extraction and analysis.

Also known as: Skin biopsy by punch

Non-sensitive skin; Sensitive Skin

Oral mucosa specimen PROCEDURE

The sample for keratinocytes from oral mucosa will be taken with a Foam knife, which is a non-invasive procedure. It does not need anesthesia, and it does not leave scars. The procedure consists in gently brush the oral mucosa with the knife five times, and the material that will be obtained will be fixed in a PBS solution for RNA analysis.

Also known as: Oral mucosa keratinocytes, Oral mucosa swap

Non-sensitive skin; Sensitive Skin

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years old
• Known response to the lactic acid stinging test
• Informed signed consent

You may not qualify if:

• Any dermatoses in the test area
• Use of topical medications in the test area
• Personal history of keloid or hypertrophic scarring
• Known allergy to lidocaine
• Know heart disease
• Pregnancy
• Breastfeeding

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 (4)

• Hernández-Blanco D, Castanedo-Cázares JP, Ehnis-Pérez A, Jasso-Ávila I, Conde-Salazar L, Torres-Álvarez B. Prevalence of sensitive skin and its biophysical response in a Mexican population. World J Dermatol 2013;2:1-7. doi:10.5314/wjd.v2.i1.1.

  BACKGROUND

• Escalas-Taberner J, Gonzalez-Guerra E, Guerra-Tapia A. [Sensitive skin: a complex syndrome]. Actas Dermosifiliogr. 2011 Oct;102(8):563-71. doi: 10.1016/j.ad.2011.04.011. Epub 2011 Jul 14. Spanish.

  PMID: 21757181 BACKGROUND

• Kueper T, Krohn M, Haustedt LO, Hatt H, Schmaus G, Vielhaber G. Inhibition of TRPV1 for the treatment of sensitive skin. Exp Dermatol. 2010 Nov;19(11):980-6. doi: 10.1111/j.1600-0625.2010.01122.x.

  PMID: 20626462 BACKGROUND

• Stander S, Schneider SW, Weishaupt C, Luger TA, Misery L. Putative neuronal mechanisms of sensitive skin. Exp Dermatol. 2009 May;18(5):417-23. doi: 10.1111/j.1600-0625.2009.00861.x.

  PMID: 19382311 BACKGROUND

Study Officials

• 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: May 27, 2013
• First Posted: June 7, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

ME (1)