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TRPV Expression in Subjects With Sensitive Skin

Distribution and Expression of Non-neuronal Transient Receptor Potential (TRPV) Ion Channels in Sensitive Skin Syndrome.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01871883
Enrollment
30
Registered
2013-06-07
Start date
2013-05-31
Completion date
2016-09-30
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensitive Skin

Keywords

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

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.

Detailed description

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. Although the pathogenesis of sensitive skin syndrome is not completely understood, the most accepted theory is the presence of an altered barrier function. Irritation results from the abnormal penetration of substances to deeper layers of the skin, where they can induce vasodilation and stimulate c-type neuronal fibers. 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 was first discovered in 1997, when it was identified as the specific receptor for capsaicin in a subgroup of nociceptors. It is a non-selective thermo-sensitive cationic channel that can be found in nerves from the central and peripheral nervous system, fibroblasts, smooth muscle, mast cells, endothelial cells, gastrointestinal, respiratory and urinary epithelial cells. TRPV1 can be activated by excessive heat (\>42ºC), acidic pH (\< 5.9), and also by endogenous substances such as N- arachidonoyl dopamine, leucotriene B, phospholipase C, and many others. In 2001, the functional expression of TRPV1 was identified in human keratinocytes. Their physiologic role in the skin has not been completely understood, but they have been related to differentiation, proliferation, inflammation and homeostasis of the epidermal barrier. Their presence in keratinocytes and cutaneous nervous fibers suggests a role in the sensitive function of the epidermis. It has been proved that the stimulation of TRPV1 in neuronal cells can induce pruritus and burning sensation. In vitro studies have demonstrated that the exogenous stimulation of TRPV1 in keratinocytes induces the release of nitric oxide, ATP, dopamine, prostaglandins, and other pro-inflammatory substances that can act as paracrine mediators between keratinocytes and cutaneous nerve fibers. Therefore, there are scientific bases to hypothesize that an increase in the expression of these receptors can be the responsible for the sensitive skin syndrome.

Interventions

PROCEDURESkin biopsy

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.

PROCEDUREOral mucosa specimen

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.

Sponsors

Hospital Central Dr. Ignacio Morones Prieto
CollaboratorOTHER
Universidad Autonoma de San Luis Potosí
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Expression of TRPV1Up to 1 yearDetermine the expression of TRPV1 in patients with sensitive skin

Secondary

MeasureTime frameDescription
TRPV1 and Sensitive SkinUp to 1 yearCorrelate the expression of TRVP1 with the presence of sensitive skin syndrome
TRPV1 and skin phototypeUp to 1 yearIdentify variations in the expression of TRPV1 according to skin phototype
TRPV1 and barrier functionUp to 1 yearCorrelate the expression of TRPV1 with the transepidermal water loss as an indirect measure of barrier function.

Other

MeasureTime frameDescription
TRPV1 mRNA in biopsiesUp to 1 yearQuantify the expression of mRNA of TRPV1 in epidermal keratinocytes obtained by skin biopsies through RT-PCR
TRPV1 in biopsies by immunohistochemistryUp to 1 yearQuantify the expression of TRPV1 in epidermal keratinocytes obtained by skin biopsies through immunohistochemistry
mRNA1 of TRPV1 in oral keratinocytesUp to 1 yearQuantify the expression of mRNA of TRPV1 in epidermal keratinocytes obtained from oral mucosa through RT-PCR
TRPV1 in oral keratinocytes by immunohistochemistryUp to 1 yearQuantify the expression of TRPV1 in epidermal keratinocytes obtained from oral mucosa through immunohistochemistry.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026