NCT02369432

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2015

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

February 16, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

February 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

2.6 years

First QC Date

February 16, 2015

Last Update Submit

October 12, 2017

Conditions

Atopic Dermatitis

Keywords

Drug carriersPolymeric microparticlesPreferential accumulation in inflamed skinAtopic dermatitisPilosebaceous folliclesSelective drug deliveryDrug reservoir

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 3

Secondary Outcomes (1)

  • Assessment of the quantity of fluorescence (assessed by number of pixels on pictures taken with confocal microscopy)

    Day 3

Study Arms (1)

Group of healthy volunteers and group of patients

EXPERIMENTAL

* 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

Drug: Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsy

Interventions

Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsyDRUG
Group of healthy volunteers and group of patients

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers:
  • Volunteers over 18
  • 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
  • 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 signed a free and informed consent form
  • Patients affiliated to a social security system

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional University Hospital

Besançon, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Philippe HUMBERT

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

February 24, 2015

Study Start

February 20, 2015

Primary Completion

October 3, 2017

Study Completion

October 3, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

FR(1)