Healthy
Conditions
Keywords
Heaklthy adult subject, Wound
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.
Interventions
PROCEDUREInduction of suction blister
For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model.
OTHERTransepidermal water loss (TEWL)
* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) * For subsequent visits, before product application
OTHERMacrophotography
* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) * For subsequent visits, before product application
DEVICEWound healing medical device
Twice daily application on superficial wounds
Sponsors
Pierre Fabre Dermo Cosmetique
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed