CompletedNCT04687839Updated Mar 19, 2021

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

An interventional study of Induction of suction blister and Transepidermal water loss (TEWL) in Healthy, sponsored by Pierre Fabre Dermo Cosmetique. Completed at 1 site in Germany. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-19.

Sponsored by Pierre Fabre Dermo Cosmetique · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 44
Allocation: Not applicable
Ages: 18 Years to 45 Years
Sex: All

Study 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 studied

Healthy

Keywords

Heaklthy adult subject
Wound

In context

Lead sponsor

Pierre Fabre Dermo Cosmetique is the lead sponsor of 58 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: 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

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

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 44 participants (actual)

Study arms

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

Interventions

ProcedureInduction of suction blister
For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model.
OtherTransepidermal water loss (TEWL)
* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) * For subsequent visits, before product application
OtherMacrophotography
* At V1, before blister suction use (T0) and after blister withdrawal before product application (T1) * For subsequent visits, before product application
DeviceWound healing medical device
Twice daily application on superficial wounds

What researchers measure

Primary outcomes

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
Time frame: Day6

Secondary outcomes

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
Time frame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Effect of the tested product on healing
By measuring the wound surface (measured by macro-photos) on treated area compared to an untreated area
Time frame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Tolerance of the tested product
By measuring the occurence of adverse event
Time frame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)

Study locations

1 site

Dr. Kirstin Deuble-Bente
Schenefeld, 22869, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04687839
Lead sponsor: Pierre Fabre Dermo Cosmetique
Responsible party: Sponsor
First posted: Dec 29, 2020
Start date: Jul 13, 2020
Primary completion: Aug 17, 2020
Completion: Aug 17, 2020
Last update: Mar 19, 2021

Study contacts

Kirstin Deuble-Bente, Dr.

principal investigator · Kiebitzweg 2, 22869 Schenefeld/Hamburg, Germany

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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