Skin AbrasionNCT06016803
Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure
A study testing Cicatryl (RL3010A - DP0378) in people with Skin Abrasion and Superficial Wound, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.
Trial 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 surface of wounds maintaining a moist environment improving the healing process thanks to its moisturizing and… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Skin Abrasion, Superficial Wound
- What is being tested?
- Cicatryl (RL3010A - DP0378)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 30 Aug 2023to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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.
- Conditions
- Skin Abrasion, Superficial Wound
- Being tested
- Cicatryl (RL3010A - DP0378)
- Keywords
- Wound healing, Medical device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cicatryl (RL3010A - DP0378)Device
Tested product is applied twice a day. The maximum duration of application is 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation | Experimental | Group applying the tested medical device Receives: Device: Cicatryl (RL3010A - DP0378) |
| Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications | Experimental | Group applying the tested medical device Receives: Device: Cicatryl (RL3010A - DP0378) |
| Subjects having undergone a skin lesion excision for which stitches were removed | Experimental | Group applying the tested medical device Receives: Device: Cicatryl (RL3010A - DP0378) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 8
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: About 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start30 Aug 2023
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AbrasionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016803
- Sponsor's protocol ID
- RL3010A2022001
- Status last verified
- Sep 2024
- First submitted
- 25 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure
- ClinicalTrials.gov ID
- NCT06016803
- Acronym / sponsor ID
- RL3010A2022001
- Conditions
- Skin Abrasion, Superficial Wound
- Keywords
- Wound healing, Medical device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation | Experimental | Device: Cicatryl (RL3010A - DP0378)Group applying the tested medical device |
| Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications | Experimental | Device: Cicatryl (RL3010A - DP0378)Group applying the tested medical device |
| Subjects having undergone a skin lesion excision for which stitches were removed | Experimental | Device: Cicatryl (RL3010A - DP0378)Group applying the tested medical device |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cicatryl (RL3010A - DP0378)Tested product is applied twice a day. The maximum duration of application is 7 days. | Device | 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 |
Primary outcome
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
Time frame: Day 8
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
7 secondary outcomes
To assess the evolution of the physical signs of local tolerance at the site of product application on the wound
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
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
Time frame: Day 3 and Day 8
To assess the soothing efficacy of the product
Time frame: Day 3 and Day 8
To assess the soothing efficacy of the product
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.
Time frame: Day 3 and Day 8
To evaluate the compliance of the subjects to product application.
Time frame: About 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cicatryl (RL3010A - DP0378) in people with Skin Abrasion and Superficial Wound, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.