NCT06016803

Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The CE-marketed medical device class IIa RL3010A - DP0378 developed by Pierre Fabre Laboratories is indicated in the treatment of superficial wounds and abrasions. It forms a protective layer on the surface of wounds maintaining a moist environment improving the healing process thanks to its moisturizing and film-forming effect. Through this study, the overall tolerance of the medical device will be evaluated in subjects presenting a superficial wound after having undergone a dermatological procedure as cryotherapy, laser (laser Nd Yag, fractional laser C02), Intense Pulse Light (IPL) or skin lesion excision for which stitches were removed.

Detailed description

This open-labelled study will be conducted as a monocentric study, in children and adults presenting a superficial wound after having undergone a dermatological act. To assess the global tolerance of the medical device RL3010A - DP0378 in subjects presenting a superficial wound after having undergone a dermatological procedure, after 7 days of twice daily applications under normal conditions of use 3 visits are planned: * Visit 1: Inclusion (D1) * Visit 2: Intermediate visit (D3) * Visit 3: Final visit (D8) The maximal duration of participation for a subject is 8 days, from the inclusion visit (visit 1) to the end of the study.

Conditions

• Skin Abrasion
• Superficial Wound

Interventions

Type	Name	Description
DEVICE	Cicatryl (RL3010A - DP0378)	Tested product is applied twice a day. The maximum duration of application is 7 days.

Timeline

• Start date: 2023-08-30
• Primary completion: 2023-11-29
• Completion: 2023-11-29
• First posted: 2023-08-30
• Last updated: 2024-09-19

Locations

1 site across 1 country: Poland