Status:
COMPLETED
Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Skin Abrasion
Superficial Wound
Eligibility:
All Genders
2+ years
Phase:
NA
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 s...
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...
Eligibility Criteria
Inclusion
- 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 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.
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06016803
Start Date
August 30 2023
End Date
November 29 2023
Last Update
September 19 2024
Active Locations (1)
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1
Dermscan Poland
Gdansk, Poland, Poland, 80288