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Completed

NCT Number: NCT04687839

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

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.

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Key information

Conditions

Healthy Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Kirstin Deuble-Bente

Schenefeld, 22869, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Induction of suction blister

Procedure

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

Transepidermal water loss (TEWL)

Other
  • At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
  • For subsequent visits, before product application

Macrophotography

Other
  • At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
  • For subsequent visits, before product application

Wound healing medical device

Device

Twice daily application on superficial wounds

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 29, 2020
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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