NCT02620293

Brief Summary

This is an open label, non-comparative investigation to determine the tolerance of Eczema Repair Emollient on healthy subjects with dry/atopic and very dry/atopic skin. The Eczema Repair Emollient will be applied for 47 hours under occlusion. Skin tolerance will be assessed immediately and 1 hour, 24, 48 and 72 hours after patch removal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2016

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

September 9, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

May 1, 2016

Enrollment Period

Same day

First QC Date

September 9, 2015

Last Update Submit

June 2, 2016

Conditions

Eczema

Outcome Measures

Primary Outcomes (1)

  • Skin tolerance assessment using the ISO 10993 scoring system through visual assessment

    Irritation of test products assessed using the Cutaneous Irritancy Index (scores range from \<1 which is non-irritant to \>4 strongly irritating

    47 hours

Study Arms (1)

Eczema Emollient

EXPERIMENTAL

Eczema Repair Emollient

Device: Eczema Repair Emollient

Interventions

Eczema Repair EmollientDEVICE

An Emollient

Eczema Emollient

Eligibility Criteria

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

You may qualify if:

  • Subjects who are able to give written informed consent and from whom written informed consent has been obtained
  • Generally healthy male and female subjects between the ages of 18 and 65 years inclusive
  • Subjects assessed by the dermatologist as having dry/atopic and very dry/ atopic skin
  • Subjects who are able to understand the study, co-operate with the study procedures and are able to attend for all study assessments

You may not qualify if:

  • Subjects with active Psoriasis or other active skin disorders or with present skin tumours or malignant disease or a history of those
  • Subjects taking antihistamine or corticoids, any medication for the treatment of diabetes mellitus, immuno-suppressive drugs or any other medication which in the opinion of the dermatologist may affect the test results.
  • Subjects with active skin disorders or a history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of the trainee dermatologist or SIT personnel may affect the test results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skin Investigation Technology

Hamburg, Germany

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Dörte Segger, PhD

    Skin Investigational Technology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2015

First Posted

December 3, 2015

Study Start

April 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-05

Locations

DE(1)