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

Primary Purpose

Skin Abrasion, Superficial Wound

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cicatryl (RL3010A - DP0378)
Sponsored by
Pierre Fabre Dermo Cosmetique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Skin Abrasion focused on measuring Wound healing, Medical device

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation

    Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications

    Subjects having undergone a skin lesion excision for which stitches were removed

    Arm Description

    Group applying the tested medical device

    Group applying the tested medical device

    Group applying the tested medical device

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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
    To assess the repairing efficacy of the product
    Scale with 4 levels ranked from worst to best : Not effective - Little effective - Effective - Very effective
    To assess the soothing efficacy of the product
    Sacle with 4 levels ranked from worst to best : Not effective - Little effective - Effective - Very effective
    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.
    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).
    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.

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 23, 2023
    Sponsor
    Pierre Fabre Dermo Cosmetique
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06016803
    Brief Title
    Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure
    Official Title
    Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    November 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pierre Fabre Dermo Cosmetique

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Abrasion, Superficial Wound
    Keywords
    Wound healing, Medical device

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation
    Arm Type
    Experimental
    Arm Description
    Group applying the tested medical device
    Arm Title
    Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications
    Arm Type
    Experimental
    Arm Description
    Group applying the tested medical device
    Arm Title
    Subjects having undergone a skin lesion excision for which stitches were removed
    Arm Type
    Experimental
    Arm Description
    Group applying the tested medical device
    Intervention Type
    Device
    Intervention Name(s)
    Cicatryl (RL3010A - DP0378)
    Intervention Description
    Tested product is applied twice a day. The maximum duration of application is 7 days.
    Primary Outcome Measure Information:
    Title
    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
    Description
    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
    Time Frame
    Day 8
    Secondary Outcome Measure Information:
    Title
    To assess the evolution of the physical signs of local tolerance at the site of product application on the wound
    Description
    Physical signs with 5 levels ranked from best to worst : None - Very mild - Mild - Moderate - Severe
    Time Frame
    Day 1 before and immediately after the test product application (10 to 30 minutes), at Day 3 and at Day 8.
    Title
    To assess the evolution of the functional signs of local tolerance at the site of product application on the wound
    Description
    Functional signs with 5 levels ranked from best to worst : None - Very mild - Mild - Moderate - Severe
    Time Frame
    Day 1 before and immediately after the test product application (10 to 30 minutes), at Day 3 and at Day 8.
    Title
    To assess the repairing efficacy of the product
    Description
    Scale with 4 levels ranked from worst to best : Not effective - Little effective - Effective - Very effective
    Time Frame
    Day 3 and Day 8
    Title
    To assess the soothing efficacy of the product
    Description
    Sacle with 4 levels ranked from worst to best : Not effective - Little effective - Effective - Very effective
    Time Frame
    Day 3 and Day 8
    Title
    To assess the soothing efficacy of the product
    Description
    Discomfort sensations with NRS ranging from 0 (None) to 10 (Hugely). Higher scores mean a worse outcome.
    Time Frame
    Day 1 before and immediately after the test product application, at Day 3 and at Day 8
    Title
    To evaluate subjects' global satisfaction as regards to the use the medical device RL3010A - DP0378.
    Description
    Global satisfaction through a specific questionnaire (Conditions of use, organoleptic properties, effects, and others will be assessed).
    Time Frame
    Day 3 and Day 8
    Title
    To evaluate the compliance of the subjects to product application.
    Description
    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.
    Time Frame
    About 8 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adeline BACQUEY
    Phone
    +33562877753
    Email
    adeline.bacquey@pierre-fabre.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christophe CHAMARD
    Phone
    +33562488566
    Email
    christophe.chamard@pierre-fabre.com

    12. IPD Sharing Statement

    Learn more about this trial

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