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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:
The maximal duration of participation for a subject is 8 days, from the inclusion visit (visit 1) to the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation | Experimental | Group applying the tested medical device |
|
| Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications | Experimental | Group applying the tested medical device |
|
| Subjects having undergone a skin lesion excision for which stitches were removed | Experimental | Group applying the tested medical device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cicatryl (RL3010A - DP0378) | Device | Tested product is applied twice a day. The maximum duration of application is 7 days. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Subject who just undergone (the same day) a dermatological procedure, done according to the investigator's usual practices:
Subject with a superficial wound after the dermatological procedure
Exclusion Criteria:
Criteria related to the skin condition :
Criteria related to treatments and/or products :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermscan Poland | Gdansk | Poland | 80288 | Poland |
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| 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 | 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 | 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 |