Status:
COMPLETED
Assessment of the Wound Healing Efficacy and Tolerance of a Medical Device on Wounds in Healthy Subjects.
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2020
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04687839
Start Date
July 13 2020
End Date
August 17 2020
Last Update
March 19 2021
Active Locations (1)
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1
Dr. Kirstin Deuble-Bente
Schenefeld, Germany, 22869