An interventional study of Cicatryl (RL3010A - DP0378) in Skin Abrasion and Superficial Wound, sponsored by Pierre Fabre Dermo Cosmetique. Completed at 1 site in Poland. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Pierre Fabre Dermo Cosmetique · Not applicable, Interventional, and Supportive care
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 60 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Pierre Fabre Dermo Cosmetique is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subject who just undergone (the same day) a dermatological procedure, done according to the investigator's usual practices:
Exclusion Criteria:
Criteria related to the skin condition :
Criteria related to treatments and/or products :
Group applying the tested medical device
Device: Cicatryl (RL3010A - DP0378)
Group applying the tested medical device
Device: Cicatryl (RL3010A - DP0378)
Group applying the tested medical device
Device: Cicatryl (RL3010A - DP0378)
Tested product is applied twice a day. The maximum duration of application is 7 days.
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
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Pierre Fabre Dermo Cosmetique