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Exploratory Study of the Cutaneous Penetration of Biodegradable Polymeric Microparticles in Atopic Dermatitis (MicroIskin)

Primary Purpose

Atopic Dermatitis

Status
Terminated
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsy
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atopic Dermatitis focused on measuring Drug carriers, Polymeric microparticles, Preferential accumulation in inflamed skin, Atopic dermatitis, Pilosebaceous follicles, Selective drug delivery, Drug reservoir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers:

    • Volunteers over 18
    • Male volunteers under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion)
    • Caucasian volunteers
    • Volunteers having never shown any type of skin lesions regardless of its origin especially any allergic skin reactions.
    • Volunteers having signed a free and informed consent form
    • Volunteers affiliated to a social security system

  • Patients:

    • Patients over 18
    • Male patients under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion)
    • Caucasian patients
    • Acute phase of atopic dermatitis with a SCORAD between 15 and 40
    • Patients suffering from atopic dermatitis skin lesions ≥ 1.5 cm² on the inside of the forearm
    • Patients having been treated by class II dermocorticoids with a two-week wash-out prior to inclusion
    • Patients having signed a free and informed consent form
    • Patients affiliated to a social security system

Exclusion Criteria:

  • Participants under 18
  • Pregnant or Breastfeeding women
  • Post-menopausal women
  • Patients having skin lesions adjacent to the selected area
  • Patients with complications of atopic dermatitis
  • SCORAD <15 or >40
  • Patients being treated with a topical or a systemic treatment influencing the skin penetration of the microparticles
  • Patients allergics to any component of the formulation
  • Patients using cosmetic products on their forearms
  • Patients planning to expose themselves to the sun
  • Patients with a known immune deficiency
  • Patients allergic to any product or device used before, during or after the skin biopsy
  • Patients suffering from known wound healing disorders
  • Patients with known inherited ou acquired hemostasis disorders
  • Patients unable to follow the protocol requirements
  • Patients currently involved in another clinical trial (or whose participation has ended less than 2 weeks before inclusion)
  • Patients who are not affiliated to a social security system
  • Patients in an exclusion period following participation in another clinical trial
  • Incapacitated adults
  • Participants placed under tutorship or curatorship
  • Participants under judicial protection

Sites / Locations

  • Regional University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group of healthy volunteers and group of patients

Arm Description

Healthy volunteers: Microparticles will be applied to the skin of the forearm and then a skin biopsy of this area will be performed Patients suffering from atopic dermatitis: Microparticles will be applied to the skin of the forearm both to an area affected by dermatitis and to an area deprived from the disease. A skin biopsy of these two areas will be performed

Outcomes

Primary Outcome Measures

Assessment of the penetration beyond the stratum corneum in human skin (fluorochrome contained in the particle will be detected by confocal microscopy)
Healthy volunteers: Microparticles are applied to the skin of the forearm and then a skin biopsy of this area is performed Patients suffering from atopic dermatitis: Microparticles are applied to the skin of the forearm both to an area affected by dermatitis and to an area deprived from the disease. A skin biopsy of these two areas is performed. The fluorochrome contained in the particle will be detected by confocal microscopy to determine whether the particles have reached beyond the stratum corneum

Secondary Outcome Measures

Assessment of the quantity of fluorescence (assessed by number of pixels on pictures taken with confocal microscopy)
This will be assessed by the number of pixels on pictures taken with confocal microscopy. It will allow for the comparison between patients/healthy volunteers and the comparison of affected/non-affected area in patients

Full Information

First Posted
February 16, 2015
Last Updated
October 12, 2017
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
University of Franche-Comté
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1. Study Identification

Unique Protocol Identification Number
NCT02369432
Brief Title
Exploratory Study of the Cutaneous Penetration of Biodegradable Polymeric Microparticles in Atopic Dermatitis
Acronym
MicroIskin
Official Title
Exploratory Study of the Cutaneous Penetration of Biodegradable Polymeric Microparticles in Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in enrolling patients
Study Start Date
February 20, 2015 (Actual)
Primary Completion Date
October 3, 2017 (Actual)
Study Completion Date
October 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
University of Franche-Comté

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This proof of concept study aims to assess in patients suffering from atopic dermatitis if polymeric microparticles reach the pilosebaceous follicles of inflamed skin.
Detailed Description
Current treatments of inflammatory skin disorders such as acne, psoriasis or atopic dermatitis are primarily topical. They have the advantage of allowing the administration of active substances directly to the skin lesions. However local treatments may have drawbacks (complex application, local and/or systemic side effects...) and cause poor compliance. The use of drug carriers is viewed as one of the most promising strategies to target and control the release of active substances to various skin sites. Polymeric microparticles have shown to have a better stability and a more sustained release pattern than other types of drug vehicles such as liposomes. Based on the results obtained in our preclinical experiments, this proof of concept study aims to assess, in patients suffering from atopic dermatitis, if biodegradable polymeric microparticles reach the pilosebaceous follicles of inflamed skin which would in turn serve as a reservoir of active substance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Drug carriers, Polymeric microparticles, Preferential accumulation in inflamed skin, Atopic dermatitis, Pilosebaceous follicles, Selective drug delivery, Drug reservoir

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group of healthy volunteers and group of patients
Arm Type
Experimental
Arm Description
Healthy volunteers: Microparticles will be applied to the skin of the forearm and then a skin biopsy of this area will be performed Patients suffering from atopic dermatitis: Microparticles will be applied to the skin of the forearm both to an area affected by dermatitis and to an area deprived from the disease. A skin biopsy of these two areas will be performed
Intervention Type
Drug
Intervention Name(s)
Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsy
Primary Outcome Measure Information:
Title
Assessment of the penetration beyond the stratum corneum in human skin (fluorochrome contained in the particle will be detected by confocal microscopy)
Description
Healthy volunteers: Microparticles are applied to the skin of the forearm and then a skin biopsy of this area is performed Patients suffering from atopic dermatitis: Microparticles are applied to the skin of the forearm both to an area affected by dermatitis and to an area deprived from the disease. A skin biopsy of these two areas is performed. The fluorochrome contained in the particle will be detected by confocal microscopy to determine whether the particles have reached beyond the stratum corneum
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Assessment of the quantity of fluorescence (assessed by number of pixels on pictures taken with confocal microscopy)
Description
This will be assessed by the number of pixels on pictures taken with confocal microscopy. It will allow for the comparison between patients/healthy volunteers and the comparison of affected/non-affected area in patients
Time Frame
Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers: Volunteers over 18 Male volunteers under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion) Caucasian volunteers Volunteers having never shown any type of skin lesions regardless of its origin especially any allergic skin reactions. Volunteers having signed a free and informed consent form Volunteers affiliated to a social security system Patients: Patients over 18 Male patients under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion) Caucasian patients Acute phase of atopic dermatitis with a SCORAD between 15 and 40 Patients suffering from atopic dermatitis skin lesions ≥ 1.5 cm² on the inside of the forearm Patients having been treated by class II dermocorticoids with a two-week wash-out prior to inclusion Patients having signed a free and informed consent form Patients affiliated to a social security system Exclusion Criteria: Participants under 18 Pregnant or Breastfeeding women Post-menopausal women Patients having skin lesions adjacent to the selected area Patients with complications of atopic dermatitis SCORAD <15 or >40 Patients being treated with a topical or a systemic treatment influencing the skin penetration of the microparticles Patients allergics to any component of the formulation Patients using cosmetic products on their forearms Patients planning to expose themselves to the sun Patients with a known immune deficiency Patients allergic to any product or device used before, during or after the skin biopsy Patients suffering from known wound healing disorders Patients with known inherited ou acquired hemostasis disorders Patients unable to follow the protocol requirements Patients currently involved in another clinical trial (or whose participation has ended less than 2 weeks before inclusion) Patients who are not affiliated to a social security system Patients in an exclusion period following participation in another clinical trial Incapacitated adults Participants placed under tutorship or curatorship Participants under judicial protection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe HUMBERT
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional University Hospital
City
Besançon
Country
France

12. IPD Sharing Statement

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Exploratory Study of the Cutaneous Penetration of Biodegradable Polymeric Microparticles in Atopic Dermatitis

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