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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687839
• Other study ID #: RL3010A2019001
• Status: Completed
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: August 17, 2020

Study information

• Verified date: December 2020
• Source: Pierre Fabre Dermo Cosmetique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 17, 2020
• Est. primary completion date: August 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Procedure:
• Induction of suction blister
For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model.

Other:
• Transepidermal water loss (TEWL)
At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) For subsequent visits, before product application
• Macrophotography
At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) For subsequent visits, before product application

Device:
• Wound healing medical device
Twice daily application on superficial wounds

Locations

Country	Name	City	State
Germany	Dr. Kirstin Deuble-Bente	Schenefeld

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Dermo Cosmetique

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Tolerance of the tested product	By measuring the occurence of adverse event	Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)