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

Sponsor
Pierre Fabre Dermo Cosmetique (Industry)
Overall Status
Completed
CT.gov ID
NCT04687839
Collaborator
(none)
44
1
1
1.1
38.3

Study Details

Study Description

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
  • Procedure: Induction of suction blister
  • Other: Transepidermal water loss (TEWL)
  • Other: Macrophotography
  • Device: Wound healing medical device
N/A

Study Design

Study Type:
Interventional
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 :
Jul 13, 2020
Actual Primary Completion Date :
Aug 17, 2020
Actual Study Completion Date :
Aug 17, 2020

Arms and Interventions

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

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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

  2. 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

  3. Tolerance of the tested product [Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)]

    By measuring the occurence of adverse event

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr. Kirstin Deuble-Bente Schenefeld Germany 22869

Sponsors and Collaborators

  • Pierre Fabre Dermo Cosmetique

Investigators

  • Principal Investigator: Kirstin Deuble-Bente, Dr., Kiebitzweg 2, 22869 Schenefeld/Hamburg, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier:
NCT04687839
Other Study ID Numbers:
  • RL3010A2019001
First Posted:
Dec 29, 2020
Last Update Posted:
Mar 19, 2021
Last Verified:
Dec 1, 2020
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

Study Results

No Results Posted as of Mar 19, 2021