- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01871883
TRPV Expression in Subjects With Sensitive Skin
Distribution and Expression of Non-neuronal Transient Receptor Potential (TRPV) Ion Channels in Sensitive Skin Syndrome.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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San Luis Potosí, Mexico, 78210
- Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sensitive Skin
Subjects with sensitive skin, diagnosed by the lactic acid stinging test.
Skin biopsy Oral mucosa specimen
|
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.
Other Names:
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.
Other Names:
|
Active Comparator: Non-sensitive skin
Subjects without sensitive skin, determined by a negative lactic acid stinging test Skin biopsy Oral mucosa specimen
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expression of TRPV1
Time Frame: Up to 1 year
|
Determine the expression of TRPV1 in patients with sensitive skin
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TRPV1 and Sensitive Skin
Time Frame: Up to 1 year
|
Correlate the expression of TRVP1 with the presence of sensitive skin syndrome
|
Up to 1 year
|
TRPV1 and skin phototype
Time Frame: Up to 1 year
|
Identify variations in the expression of TRPV1 according to skin phototype
|
Up to 1 year
|
TRPV1 and barrier function
Time Frame: Up to 1 year
|
Correlate the expression of TRPV1 with the transepidermal water loss as an indirect measure of barrier function.
|
Up to 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TRPV1 mRNA in biopsies
Time Frame: Up to 1 year
|
Quantify the expression of mRNA of TRPV1 in epidermal keratinocytes obtained by skin biopsies through RT-PCR
|
Up to 1 year
|
TRPV1 in biopsies by immunohistochemistry
Time Frame: Up to 1 year
|
Quantify the expression of TRPV1 in epidermal keratinocytes obtained by skin biopsies through immunohistochemistry
|
Up to 1 year
|
mRNA1 of TRPV1 in oral keratinocytes
Time Frame: Up to 1 year
|
Quantify the expression of mRNA of TRPV1 in epidermal keratinocytes obtained from oral mucosa through RT-PCR
|
Up to 1 year
|
TRPV1 in oral keratinocytes by immunohistochemistry
Time Frame: Up to 1 year
|
Quantify the expression of TRPV1 in epidermal keratinocytes obtained from oral mucosa through immunohistochemistry.
|
Up to 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- 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"
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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. Erratum In: Exp Dermatol. 2009 Dec;18(12):1096.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRPV1SenSk
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