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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Procedure: Induction of suction blister
* Other: Transepidermal water loss (TEWL)
* Other: Macrophotography
* Device: Wound healing medical device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy adult subjects<br>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<br>* For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model.<br>Other: Transepidermal water loss (TEWL)<br>* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) For subsequent visits, before product application<br>Other: Macrophotography<br>* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) For subsequent visits, before product application<br>Device: Wound healing medical device<br>* Twice daily application on superficial wounds<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heaklthy adult subject, Wound