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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Abrasion; Superficial Wound
• Intervention / Treatment: Device: Cicatryl (RL3010A - DP0378)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeline BACQUEY; Phone Number: +33562877753; Email: adeline.bacquey@pierre-fabre.com
• Study Contact Backup: Name: Christophe CHAMARD; Phone Number: +33562488566; Email: christophe.chamard@pierre-fabre.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject who just undergone (the same day) a dermatological procedure, done according to the investigator's usual practices:

  • Group 1: Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation
  • Group 2: Laser (laser Nd Yag, fractional laser C02) or Intense pulse Light (IPL) procedure for dermatological or aesthetical indications (including tattoo removal and depilation)
  • Group 3: Skin lesion excision for which stitches were removed
• Subject with a superficial wound after the dermatological procedure

Exclusion Criteria:

Criteria related to the skin condition :

• Subject having received artificial UV exposure, excessive or prolonged exposure to natural sunlight on the studied area within 4 weeks before the inclusion visit or planning to be exposed to artificial UV, excessive or prolonged natural sunlight during the study
• Subject having a skin disease, skin abnormalities, or dermatological condition on the studied area other than the indication of the dermatological procedure liable to interfere with the study assessments (including infectious or inflammatory dermatosis, photodermatosis, etc.)
• Subject with a known history of allergy or contact dermatitis caused by any of the ingredients of the tested product, antiseptic, dressing or latex (if used by the center)
• Subject with healing disorders
• Subject with coagulation disorders
• Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute) Hepatitis
• Other acute, chronic or progressive disease or medical history considered by the investigator hazardous for the subject or incompatible with the study or liable to interfere with the study assessments

Criteria related to treatments and/or products :

• Systemic corticosteroid treatment in the 4 weeks prior to the inclusion visit or ongoing or planned to be started during the study
• Systemic antibiotics treatment in the 2 weeks prior to the inclusion visit, ongoing or planned to be started during the study
• Systemic treatments that may affects homeostasis (anticoagulant therapy, platelet aggregation inhibitor) in the 4 weeks prior to the inclusion visit, ongoing or planned to be started during the study
• Any other systemic treatment that may affect the healing process, or incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study
• Topical steroid, non-steroid anti-inflammatory, immunomodulator and antibiotics treatments applied on the tested area in the 2 weeks prior to the inclusion visit, ongoing or planned to be started during the study
• Any topical repairing treatment or product applied on the tested area between the dermatological procedure (stitch removal for group 3) and the inclusion visit
• Any other topical treatment on the tested area that may affect the healing process, or incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation; Group applying the tested medical device	Device: Cicatryl (RL3010A - DP0378); Tested product is applied twice a day. The maximum duration of application is 7 days.
Experimental: Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications; Group applying the tested medical device	Device: Cicatryl (RL3010A - DP0378); Tested product is applied twice a day. The maximum duration of application is 7 days.
Experimental: Subjects having undergone a skin lesion excision for which stitches were removed; Group applying the tested medical device	Device: Cicatryl (RL3010A - DP0378); Tested product is applied twice a day. The maximum duration of application is 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Global tolerance with 5 levels ranked from best to worst : Excellent (No functional nor physical signs related to the investigational product observed or reported by the subjects) - Very good - Good - Moderate - Bad	Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the evolution of the physical signs of local tolerance at the site of product application on the wound	Physical signs with 5 levels ranked from best to worst : None - Very mild - Mild - Moderate - Severe	Day 1 before and immediately after the test product application (10 to 30 minutes), at Day 3 and at Day 8.
To assess the evolution of the functional signs of local tolerance at the site of product application on the wound	Functional signs with 5 levels ranked from best to worst : None - Very mild - Mild - Moderate - Severe	Day 1 before and immediately after the test product application (10 to 30 minutes), at Day 3 and at Day 8.
To assess the repairing efficacy of the product	Scale with 4 levels ranked from worst to best : Not effective - Little effective - Effective - Very effective	Day 3 and Day 8
To assess the soothing efficacy of the product	Sacle with 4 levels ranked from worst to best : Not effective - Little effective - Effective - Very effective	Day 3 and Day 8
To assess the soothing efficacy of the product	Discomfort sensations with NRS ranging from 0 (None) to 10 (Hugely). Higher scores mean a worse outcome.	Day 1 before and immediately after the test product application, at Day 3 and at Day 8
To evaluate subjects' global satisfaction as regards to the use the medical device RL3010A - DP0378.	Global satisfaction through a specific questionnaire (Conditions of use, organoleptic properties, effects, and others will be assessed).	Day 3 and Day 8
To evaluate the compliance of the subjects to product application.	The subject / subject's parent(s) will report in his/her diary the applications of investigational product and any omissions or changes in the frequency.	About 8 days

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Wound healing; Medical device
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: RL3010A2022001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No