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

Assessment of the Wound Healing Efficacy and Tolerance of the Medical Device RL3010A DP0378 on a Blister Suction Model in Healthy Subjects.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: Induction of suction blister; Other: Transepidermal water loss (TEWL); Other: Macrophotography; Device: Wound healing medical device

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schenefeld, Germany, 22869
    • Dr. Kirstin Deuble-Bente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject with a phototype I, II or III according to the Fitzpatrick scale
• Subject aged between 18 and 45 years included at selection visit
• Subject with absence of infectious diseases (HIV and Hepatitis), confirmed by negative blood test results

Exclusion Criteria:

• History of keloids and hypertrophic scars
• Subject with removal of axillary lymph nodes
• Pathology, active skin disease or dermatological condition in progress (psoriasis and/or lichen ruber and/or eczema ...) or presence of dermatological lesions on the inner side of the forearm (solar erythema or dermatosis ...) that may affect the performance of the research or judged incompatible with the realization of the study
• Subject with severe illness (severe infectious disease (e.g. severe flu)), chronic disease or acute evolutionary pathology likely to influence the study results or considered by the investigator hazardous for the subject or incompatible with the study
• Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute) Hepatitis
• Subject presenting a healing pathology or a pathology with consequences on the healing like the diabetes mellitus (type I and type II)
• Subject with congenital methemoglobinemia or porphyria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy adult subjects; It's a randomized intra-individual comparative study with two injured study areas (treated and untreated) for each subject. The randomization will determine the application side on which the tested product will be applied (RIGHT or LEFT forearm). Twice daily application on the treated area.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the tested product on the wound healing at D6	By measuring the wound surface (measured by macro-photos) on treated area compared to an untreated area	Day6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the tested product on the cutaneous barrier restoration	By measuring the TEWL (Trans Epidermal Water Loss) on treated area compared to an untreated area	Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Effect of the tested product on healing	By measuring the wound surface (measured by macro-photos) on treated area compared to an untreated area	Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Tolerance of the tested product	By measuring the occurence of adverse event	Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Investigators: Principal Investigator: Kirstin Deuble-Bente, Dr., Kiebitzweg 2, 22869 Schenefeld/Hamburg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Actual): August 17, 2020
• Study Completion (Actual): August 17, 2020

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Heaklthy adult subject; Wound
• Other Study ID Numbers: RL3010A2019001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No