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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Procedure: Induction of suction blister; Other: Transepidermal water loss (TEWL); Other: Macrophotography; Device: Wound healing medical device

• Registration Number: NCT04687839
• Lead Sponsor: Pierre Fabre Dermo Cosmetique

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-13
• Primary Completion: 2020-08-17
• Study Completion: 2020-08-17
• Study First Submitted: 2020-09-02
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy adult subjects	Macrophotography	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.
Healthy adult subjects	Induction of suction blister	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.
Healthy adult subjects	Transepidermal water loss (TEWL)	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.
Healthy adult subjects	Wound healing medical device	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dr. Kirstin Deuble-Bente; 🇩🇪 Schenefeld, Germany