NCT04687839

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-13
• Primary completion: 2020-08-17
• Completion: 2020-08-17
• First posted: 2020-12-29
• Last updated: 2021-03-19

Locations

1 site across 1 country: Germany