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.
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
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Tested product is applied twice a day. The maximum duration of application is 7 days.
Dermscan Poland
Gdansk, Poland, Poland
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
Time frame: Day 8
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
Time frame: 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
Time frame: 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
Time frame: Day 3 and Day 8
To assess the soothing efficacy of the product
Scale with 4 levels ranked from worst to best : Not effective - Little effective - Effective - Very effective
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: About 8 days
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