Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure
Skin Abrasion, Superficial Wound
About this trial
This is an interventional supportive care trial for Skin Abrasion focused on measuring Wound healing, Medical device
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
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
Group applying the tested medical device
Group applying the tested medical device
Group applying the tested medical device