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

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ClinicalTrials.gov Identifier: NCT04687839
Recruitment Status : Completed
First Posted : December 29, 2020
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Dermo Cosmetique

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Procedure: Induction of suction blister Other: Transepidermal water loss (TEWL) Other: Macrophotography Device: Wound healing medical device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessment of the Wound Healing Efficacy and Tolerance of the Medical Device RL3010A DP0378 on a Blister Suction Model in Healthy Subjects.
Actual Study Start Date : July 13, 2020
Actual Primary Completion Date : August 17, 2020
Actual Study Completion Date : August 17, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy adult subjects

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
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

Other: 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


Outcome Measures
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Primary Outcome Measures :
  1. Effect of the tested product on the wound healing at D6 [ Time Frame: Day6 ]
    By measuring the wound surface (measured by macro-photos) on treated area compared to an untreated area


Secondary Outcome Measures :
  1. Effect of the tested product on the cutaneous barrier restoration [ Time Frame: 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

  2. Effect of the tested product on healing [ Time Frame: 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

  3. Tolerance of the tested product [ Time Frame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1) ]
    By measuring the occurence of adverse event


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04687839


Locations
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Germany
Dr. Kirstin Deuble-Bente
Schenefeld, Germany, 22869
Sponsors and Collaborators
Pierre Fabre Dermo Cosmetique
Investigators
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Principal Investigator: Kirstin Deuble-Bente, Dr. Kiebitzweg 2, 22869 Schenefeld/Hamburg, Germany
More Information
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Responsible Party: Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier: NCT04687839    
Other Study ID Numbers: RL3010A2019001
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pierre Fabre Dermo Cosmetique:
Heaklthy adult subject
Wound