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

NCT04687839 | Completed

• 1 other identifier: RL3010A2019001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Heaklthy adult subject; Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Effect of the tested product on the cutaneous barrier restoration

  Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)

• Effect of the tested product on healing

  Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)

• Tolerance of the tested product

  Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)

Study Arms (1)

Healthy adult subjects

EXPERIMENTAL

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; Other: Transepidermal water loss (TEWL); Other: Macrophotography; Device: Wound healing medical device

Interventions

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.

Healthy adult subjects

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

Healthy adult subjects

Macrophotography OTHER

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

Healthy adult subjects

Wound healing medical device DEVICE

Twice daily application on superficial wounds

Healthy adult subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Dr. Kirstin Deuble-Bente

Schenefeld, 22869, Germany

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Kirstin Deuble-Bente, Dr.

  Kiebitzweg 2, 22869 Schenefeld/Hamburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: December 29, 2020
• Study Start: July 13, 2020
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: March 19, 2021

Record last verified: 2020-12

Locations

DE (1)