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Assessment of the Wound Healing Efficacy and Tolerance of a Medical Device on Wounds in Healthy Subjects.

NCT04687839 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-03-19

No results posted yet for this study

Summary

The tested medical device is indicated for the treatment of wounds and small skin injuries. The intention of this study is to evaluate the tolerance and efficacy of the test product by measuring the recovery of the skin barrier after wound produced by suction blister. But also, by validating the accompanying physiological effect of the study product during this recovery.

Conditions

  • Healthy

Interventions

PROCEDURE

Induction of suction blister

For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model.

OTHER

Transepidermal water loss (TEWL)

* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) * For subsequent visits, before product application

OTHER

Macrophotography

* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) * For subsequent visits, before product application

DEVICE

Wound healing medical device

Twice daily application on superficial wounds

Sponsors & Collaborators

  • Pierre Fabre Dermo Cosmetique

    lead INDUSTRY

Principal Investigators

  • Kirstin Deuble-Bente, Dr. · Kiebitzweg 2, 22869 Schenefeld/Hamburg, Germany

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2020-08-17
Completion
2020-08-17

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04687839 on ClinicalTrials.gov