Sensitive SkinPhase 4NCT01871883
TRPV Expression in Subjects With Sensitive Skin
A Phase 4 study testing Skin biopsy and Oral mucosa specimen in people with Sensitive Skin, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitive Skin
- What is being tested?
- Skin biopsy and Oral mucosa specimen
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- May 2013to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Known response to the lactic acid stinging test
- Informed signed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, San Luis Potosí, 78210
About this study
Official title: 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.
Read the 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.
- Conditions
- Sensitive Skin
- Being tested
- Skin biopsy, Oral mucosa specimen
- Keywords
- Sensitive skin, Transient potential receptor vanilloid 1, TRPV1, Transepidermal water loss, Skin Phototype, Lactic acid test, Skin irritancy tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or surgery
Also called Skin biopsy by punch
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.
Oral mucosa specimenProcedure or surgery
Also called Oral mucosa keratinocytes, Oral mucosa swap
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.
| Study group | Role | What they receive |
|---|---|---|
| Sensitive Skin | Experimental | Subjects with sensitive skin, diagnosed by the lactic acid stinging test. Skin biopsy Oral mucosa specimen Receives: 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 Receives: Procedure: Skin biopsy; Procedure: Oral mucosa specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of TRPV1
Determine the expression of TRPV1 in patients with sensitive skin
Measured: Up to 1 year
Secondary outcomes (3)
TRPV1 and Sensitive Skin
Correlate the expression of TRVP1 with the presence of sensitive skin syndrome
Measured: Up to 1 year
TRPV1 and skin phototype
Identify variations in the expression of TRPV1 according to skin phototype
Measured: Up to 1 year
TRPV1 and barrier function
Correlate the expression of TRPV1 with the transepidermal water loss as an indirect measure of barrier function.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sensitive SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Responsible party
- Principal investigator, Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
- Investigators
- Adriana Ehnis-Pérez, MD, Principal investigator, Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"Juan P Castanedo-Cázares, MD, Study director, Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"Bertha Torres-Álvarez, MD, Study chair, Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871883
- Sponsor's protocol ID
- TRPV1SenSk
- Status last verified
- Nov 2015
- First submitted
- 27 May 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21757181Kueper 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.
PubMed 20626462Stander 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.
PubMed 19382311
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution and Expression of Non-neuronal Transient Receptor Potential (TRPV) Ion Channels in Sensitive Skin Syndrome.
- ClinicalTrials.gov ID
- NCT01871883
- Acronym / sponsor ID
- TRPV1SenSk
- Conditions
- Sensitive Skin
- Keywords
- Sensitive skin, Transient potential receptor vanilloid 1, TRPV1, Transepidermal water loss, Skin Phototype, Lactic acid test, Skin irritancy tests
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Study start
- May 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensitive Skin | Experimental | Procedure: Skin biopsy, Procedure: Oral mucosa specimenSubjects with sensitive skin, diagnosed by the lactic acid stinging test. Skin biopsy Oral mucosa specimen |
| Non-sensitive skin | Active comparator | Procedure: Skin biopsy, Procedure: Oral mucosa specimenSubjects without sensitive skin, determined by a negative lactic acid stinging test Skin biopsy Oral mucosa specimen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old
- Known response to the lactic acid stinging test
- Informed signed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsyAlso: Skin biopsy by punchTwo 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. | Procedure or surgery | Non-sensitive skin, Sensitive Skin |
| Oral mucosa specimenAlso: Oral mucosa keratinocytes, Oral mucosa swapThe 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. | Procedure or surgery | Non-sensitive skin, Sensitive Skin |
Primary outcome
Expression of TRPV1
Time frame: Up to 1 year
Determine the expression of TRPV1 in patients with sensitive skin
3 secondary outcomes
TRPV1 and Sensitive Skin
Time frame: Up to 1 year
TRPV1 and skin phototype
Time frame: Up to 1 year
TRPV1 and barrier function
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- BackgroundHernández-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: PubMed 21757181Escalas-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.
- Background: PubMed 20626462Kueper 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.
- Background: PubMed 19382311Stander 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Ehnis-Pérez, MD principal investigator
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Juan P Castanedo-Cázares, MD study director
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Bertha Torres-Álvarez, MD study chair
Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Skin biopsy and Oral mucosa specimen in people with Sensitive Skin, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of TRPV1 (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01871883, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.