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

Pierre Fabre

Status: Completed

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04687839

RL3010A2019001

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Healthy adult subjects

Experimental group

Description:

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.

Treatment:

Device: Wound healing medical device

Procedure: Induction of suction blister

Other: Transepidermal water loss (TEWL)

Other: Macrophotography