Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT06016803
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure
Sponsor:
Pierre Fabre Dermo Cosmetique
Organization:
Study Overview
Official Title:
Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: