Atopic DermatitisDA-TRPM8NCT03610386
Effects of an Anti-TRPM8 in the Atopic Dermatitis Pruritus
A study testing Adding menthoxypropanediol to the biopsy and No adding menthoxypropanediol to the biopsy in people with Atopic Dermatitis, run by University Hospital, Brest at 1 site in France.
Trial summary
The aim of the study is to analyse the effect of the menthoxypropanediol, a derivative of menthol, on the pruritus of atopic dermatitis (ex vivo study). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Adding menthoxypropanediol to the biopsy and No adding menthoxypropanediol to the biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2018to 29 Jan 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age with atopic dermatitis.
- AND presenting active itchy lesions,
- Patients with no systemic and / or topical treatment for AD or pruritus.
- Patients who gave their written consent
Who cannot join
- Patients with a physical or psychological disability to sign the consent.
- Patients not supported by social security.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vitro Study Of the Effects of the Menthoxypropanediol, an Anti-TRPM8, in the Atopic Dermatitis Pruritus
The aim of the study is to analyse the effect of the menthoxypropanediol, a derivative of menthol, on the pruritus of atopic dermatitis (ex vivo study).
Read the detailed description
AD is a fairly common pathology whose prevalence in Western Europe and the United States is estimated at 10 to 15% in children and 4 to 7% in adults. This frequency has been steadily increasing for several decades. However, while the prevalence is increasing rapidly in emerging countries, a plateau has been observed for a few years in the industrialized countries with a maximum of 20% reached in Northern Europe.
The predominant symptom of AD is pruritus. It has a strong impact on the lives of patients both physically, psychologically and socially, which causes stress and sleep disorders. Because of this pruritus, sleep disturbances but also the displaying character of the disease, the quality of life of patients and their families is very often altered.
The pathophysiology of this chronic pathology and associated pruritus is complex and incompletely understood and current treatments are unfortunately only symptomatic.
Many receptors (TRPA1, TRPV1, PAR2 ...), molecules (neuromediators, neuropeptides, histamine ...) and secreted cytokines (IL-2, -4, -13 and -31, TSLP) are involved in the induction and mediation of chronic pruritus. Their role in pruritus associated with AD begins to be understood. Among them, the TRPM 8 has a particular interest. Indeed, this receptor belongs to the superfamily of the "potential transient receptor (TRP)" whose members are known to play a major role in sensory perceptions, including the perception of pruritus. TRPM8 is a thermoreceptor, activated by cold (T <28 ° C) or compounds such as menthol or derivatives, or eucalyptus and the beneficial action of menthol in the soothing of pruritus makes the TRPM8 receptor an attractive therapeutic target for treatment of pruritus in AD. Its role has never been studied in this context.
This project aims to study the role of TRPM8 in the pathophysiology of pruritus in AD in an in vitro model. Biopsies of atopic dermatitis patients (2/patient in pruritic skin lesion) will be put in culture and submit to topical application of menthoxypropanediol. The effect of this molecule on receptors involved in pruritus pathway will be assay (immunohistochemistry, QPCR).
- Conditions
- Atopic Dermatitis
- Being tested
- Adding menthoxypropanediol to the biopsy, No adding menthoxypropanediol to the biopsy
- Keywords
- Atopic, Dermatitis, TRPM8, menthol
- Medical subject headings
- Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adding menthoxypropanediol to the biopsyOther
Two biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. They will be situated in a pruritic lesion area little or not visible (inside of the arm, the back …). One of the two biopsies will receive menthoxypropanediol topically.
No adding menthoxypropanediol to the biopsyOther
Two biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. They will be situated in a pruritic lesion area little or not visible (inside of the arm, the back …). One of the two biopsies will not receive menthoxypropanediol.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Two biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. They will be situated in a pruritic lesion area little or not visible (inside of the arm, the back …).One of two biopsies will be left in culture for 24 hours and then the biopsy will be cut in half: half will be used for immunohistochemical analyzes, the second half for transcriptomic analyzes . Receives: Other: No adding menthoxypropanediol to the biopsy |
| Treatment with menthoxypropanediol | Experimental | Two biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. Thy will be situated in a pruritic lesion area little or not visible (inside of the arm, the back …).One of two biopsies will be left in culture for 24 hours. Then the menthoxypropanediol (200 µM) will be applied topically on this explant and left for 6 hours. Then the biopsy will be cut in half: half will be used for immunohistochemical analyzes, the second half for transcriptomic analyzes. Receives: Other: Adding menthoxypropanediol to the biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitigation of pruritus markers after topical application of menthoxypropanediol on AD skin biopsies : proteins expression analysis
For proteins expression analysis, Immunostaining of specific receptors and proteins will be made on skin sections of AD skin biopsy. Photos will be realized with an "Axiocam" camera and analyzed by "Axiovision" software. Staining intensity of each will be evaluated in well-defined reference areas by quantitative (immuno-)histomorphometry by using ImageJ software. Relative intensity of each receptor or protein of AD patient biopsy treated or not by menthoxypropanediol will be compared to each other and compared also to healthy skin.
Measured: ONE DAY
Mitigation of pruritus markers after topical application of menthoxypropanediol on AD skin biopsies : transcriptomic analysis
For transcriptomic analysis, RNA from AD skin biopsies will be extracted and QPCR analysis will be performed. Variation of receptor and proteins expression with and without menthoxypropanediol treatment will be realized on AD skin and also compared to healthy skin.
Measured: ONE DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start21 Nov 2018
- Primary completion29 Jan 2019
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Beiersdorf
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610386
- Sponsor's protocol ID
- DA-TRPM8 (29BRC18.0077)
- Acronym
- DA-TRPM8
- Status last verified
- Dec 2021
- First submitted
- 12 Jun 2018
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Study Of the Effects of the Menthoxypropanediol, an Anti-TRPM8, in the Atopic Dermatitis Pruritus
- ClinicalTrials.gov ID
- NCT03610386
- Acronym / sponsor ID
- DA-TRPM8 / DA-TRPM8 (29BRC18.0077)
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic, Dermatitis, TRPM8, menthol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Beiersdorf
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 1 Aug 2018 (actual)
- 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.
The aim of the study is to analyse the effect of the menthoxypropanediol, a derivative of menthol, on the pruritus of atopic dermatitis (ex vivo study).
Detailed description
AD is a fairly common pathology whose prevalence in Western Europe and the United States is estimated at 10 to 15% in children and 4 to 7% in adults. This frequency has been steadily increasing for several decades. However, while the prevalence is increasing rapidly in emerging countries, a plateau has been observed for a few years in the industrialized countries with a maximum of 20% reached in Northern Europe.
The predominant symptom of AD is pruritus. It has a strong impact on the lives of patients both physically, psychologically and socially, which causes stress and sleep disorders. Because of this pruritus, sleep disturbances but also the displaying character of the disease, the quality of life of patients and their families is very often altered.
The pathophysiology of this chronic pathology and associated pruritus is complex and incompletely understood and current treatments are unfortunately only symptomatic.
Many receptors (TRPA1, TRPV1, PAR2 ...), molecules (neuromediators, neuropeptides, histamine ...) and secreted cytokines (IL-2, -4, -13 and -31, TSLP) are involved in the induction and mediation of chronic pruritus. Their role in pruritus associated with AD begins to be understood. Among them, the TRPM 8 has a particular interest. Indeed, this receptor belongs to the superfamily of the "potential transient receptor (TRP)" whose members are known to play a major role in sensory perceptions, including the perception of pruritus. TRPM8 is a thermoreceptor, activated by cold (T <28 ° C) or compounds such as menthol or derivatives, or eucalyptus and the beneficial action of menthol in the soothing of pruritus makes the TRPM8 receptor an attractive therapeutic target for treatment of pruritus in AD. Its role has never been studied in this context.
This project aims to study the role of TRPM8 in the pathophysiology of pruritus in AD in an in vitro model. Biopsies of atopic dermatitis patients (2/patient in pruritic skin lesion) will be put in culture and submit to topical application of menthoxypropanediol. The effect of this molecule on receptors involved in pruritus pathway will be assay (immunohistochemistry, QPCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: No adding menthoxypropanediol to the biopsyTwo biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. They will be situated in a pruritic lesion area little or not visible (inside of the arm, the back …).One of two biopsies will be left in culture for 24 hours and then the biopsy will be cut in half: half will be used for immunohistochemical analyzes, the second half for transcriptomic analyzes . |
| Treatment with menthoxypropanediol | Experimental | Other: Adding menthoxypropanediol to the biopsyTwo biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. Thy will be situated in a pruritic lesion area little or not visible (inside of the arm, the back …).One of two biopsies will be left in culture for 24 hours. Then the menthoxypropanediol (200 µM) will be applied topically on this explant and left for 6 hours. Then the biopsy will be cut in half: half will be used for immunohistochemical analyzes, the second half for transcriptomic analyzes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years of age with atopic dermatitis.
- AND presenting active itchy lesions,
- Patients with no systemic and / or topical treatment for AD or pruritus.
- Patients who gave their written consent
Key exclusion criteria (2 listed)
- Patients with a physical or psychological disability to sign the consent.
- Patients not supported by social security.
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 |
|---|---|---|
| Adding menthoxypropanediol to the biopsyTwo biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. They will be situated in a pruritic lesion area little or not visible (inside of the arm, the back …). One of the two biopsies will receive menthoxypropanediol topically. | Other | Treatment with menthoxypropanediol |
| No adding menthoxypropanediol to the biopsyTwo biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. They will be situated in a pruritic lesion area little or not visible (inside of the arm, the back …). One of the two biopsies will not receive menthoxypropanediol. | Other | Control |
Primary outcome
Mitigation of pruritus markers after topical application of menthoxypropanediol on AD skin biopsies : proteins expression analysis
Time frame: ONE DAY
For proteins expression analysis, Immunostaining of specific receptors and proteins will be made on skin sections of AD skin biopsy. Photos will be realized with an "Axiocam" camera and analyzed by "Axiovision" software. Staining intensity of each will be evaluated in well-defined reference areas by quantitative (immuno-)histomorphometry by using ImageJ software. Relative intensity of each receptor or protein of AD patient biopsy treated or not by menthoxypropanediol will be compared to each other and compared also to healthy skin.
Mitigation of pruritus markers after topical application of menthoxypropanediol on AD skin biopsies : transcriptomic analysis
Time frame: ONE DAY
For transcriptomic analysis, RNA from AD skin biopsies will be extracted and QPCR analysis will be performed. Variation of receptor and proteins expression with and without menthoxypropanediol treatment will be realized on AD skin and also compared to healthy skin.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adding menthoxypropanediol to the biopsy and No adding menthoxypropanediol to the biopsy in people with Atopic Dermatitis, run by University Hospital, Brest at 1 site in France.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 28 Dec 2021. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mitigation of pruritus markers after topical application of menthoxypropanediol on AD skin biopsies : proteins expression analysis (time frame: ONE DAY). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2021.