NCT03610386

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2019

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

June 12, 2018

Last Update Submit

December 10, 2021

Conditions

Atopic Dermatitis

Keywords

AtopicDermatitisTRPM8menthol

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    ONE DAY

Study Arms (2)

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 .

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.

Other: Adding menthoxypropanediol to the biopsy

Interventions

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.

Treatment with menthoxypropanediol
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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with a physical or psychological disability to sign the consent.
  • Patients not supported by social security.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brest

Brest, France

Location

MeSH Terms

Conditions

Dermatitis, AtopicDermatitis

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2018

First Posted

August 1, 2018

Study Start

November 21, 2018

Primary Completion

January 29, 2019

Study Completion

January 29, 2019

Last Updated

December 28, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)