Skin ScarsNCT07020507
Exploratory Study to Evaluate the Efficacy of the Cosmetic Product RV3895A on Re-epidermised Scars Following Burns and Surgical Stitches in Adults, Adolescents and Children Over a 6-month Follow-up Period
An observational study of Skin Scars and Post-burn Scars, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
This study is exploratory, non-comparative and open-label, conducted in France. It aims to provide insights into the effectiveness and safety of RV3895A - RY1774, potentially benefiting participants by improving scar appearance and quality of life.The aim of this study is to evaluate the efficacy of the cosmetic… Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Skin Scars, Post-burn Scars, Post-surgical-stitches Scars
- What is being tested?
- Product gel RV3895A
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2021to 3 Oct 2023
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects were recruited from their usual consultations and/or from the centre's registry. If necessary, advertisements were used. Subjects corresponding to the eligibility criteria could receive a telephone call, letter or email offering them to take part in this clinical study.
Who may be able to join
- Male or female
- For group 1: subjects aged between 18 to 65 included
- For group 2: subjects aged between 2 to 17 years included
- Subject with superficial scar(s):
- Red and re-epidermised
- Less than 6 months old
Show all 29Show fewer
- For subgroups 1A and 2A: Located on the body and/or face
- For sub-group 1C: Located on the upper limbs and/or neck and/or face
- For group 1A: spread over an area less than or equal to 30% of the body surface area
- For group 1C: spread over an area less than or equal to 15% of the body surface area
- For group 2: spread over an area less than or equal to 10% of the body surface area
- For sub-groups 1A and 2A: deep 2nd degree burns, whether grafted or not and/or in the 3rd degree graft(s) with limited cutaneous involvement and preservation of underlying structures
- For sub-group 1C: post-surgical suture requiring stitches to be inserted and removed if applicable (case of non-absorbable stitches)
- NON-INCLUSION CRITERIA:
- Subject with abundant hairiness on the instrumental measurement area
- Subject with a known history of scarring problems such as keloid scars
- Subject with superinfected scar(s)
- Subject with non-re-epidermised scar(s)
- Subject with contraindications to scar massage according to investigator assessment (dermatological conditions, treatment, pathologies, etc.) apart from a stage of scarring or a type of scar that does not allow scar massage (e.g. inflammatory scar).
- Subject with another dermatological condition (including pityriasis versicolor, severe pigmentation disorders (vitiligo, melasma, multiple lentigines, numerous and/or congenital nevi in particular if extensive)) or characteristics (e.g. tattoo) on the studied scar(s), liable to interfere with the study evaluations, or considered hazardous for the subject or incompatible with the study requirements, in the opinion of the investigator
- Subject with a pathology that may interfere with the healing stages (such as vascular pathologies, diabetes, chronic smoking associated with vascular complications...)
- Systemic treatments derived from vitamin A (retinoids, etc.) taken within the 2 months before the inclusion visit or planned during the study
- Systemic treatment with corticosteroids and/or immunosuppressants taken within the 4 weeks before the inclusion visit or planned during the study
- Surgery (other than that which caused the scar(s)) or chemical or significantly invasive dermatological treatment on the studied scar(s) liable to interfere, according to investigator assessment, with the study results within the previous weeks before the inclusion visit or planned during the study
- Systemic or topical treatments on the studied scar(s) having an influence on pruritus (benzodiazepines, antihistamines...) established or modified within the weeks before the inclusion visit or planned to be established or modified during the study and considered as not stabilised according to investigator assessment
- Topical corticosteroid and/or immunosuppressants treatments applied on the studied scar(s) within 2 weeks before the inclusion visit or planned during the study
- Silicone-based scar treatment/product(s) applied within the wound healing phase to the studied scar(s)
- Any other scar care product(s) (emollient, etc.) applied on the studied scar(s) within the week before the inclusion visit*
- Water applied on the studied scar(s) within 2 hours before the inclusion * Other medicinal or physical treatments for the scar(s) are authorised (clothing/compressive dressings, massages, stabilised topical antihistamines, thermal water, etc.).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Clinique de Rééducation et de Réadaptation Fonctionnelle du Docteur Jean Ster
Lamalou-les-Bains, 34240
About this study
This study is exploratory, non-comparative and open-label, conducted in France. It aims to provide insights into the effectiveness and safety of RV3895A - RY1774, potentially benefiting participants by improving scar appearance and quality of life.The aim of this study is to evaluate the efficacy of the cosmetic product RV3895A - RY1774 on re-epidermised scars of the face and body following burns and surgical stitches in adults, adolescents and children over a 6-month follow-up period.
Patients are divided into 2 groups:
Read more
- Group 1: adults with:
- Subgroup 1A: adults with post-burn scar(s)
- Subgroup 1C: adults with post-surgical scar(s) requiring stitches to be inserted and removed if applicable (in the case of non-absorbable stitches).
- Group 2: children and/or adolescents including children aged 2 to 7 years inclusive with:
- Subgroup 2A: children/adolescents with post-burn scar(s)
The study consists of 4 visits:
Visit 1: Inclusion (Day 1), Visit 2: Intermediate visit (Day 22), Visit 3: Intermediate visit (Day 85), Visit 4: End-of-study visit (planned or anticipated) (Day 169 )
- Conditions
- Skin Scars, Post-burn Scars, Post-surgical-stitches Scars
- Being tested
- Product gel RV3895A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product gel RV3895AOther
The product is applied twice a day to the scar(s) under study, avoiding all contact with natural orifices (and avoiding ingestion by children in the case of application to the hands in particular). The product is applied using a specific massage technique developed for the product and which is explained by the investigator at visit 1. The product is applied in sufficient quantity to cover the application area.
| Study group | Role | What they receive |
|---|---|---|
| Group 1A | Adults with post-burn scar(s) Receives: Other: Product gel RV3895A | |
| Group 1C | Adults with post-suture scar(s) requiring stitches to be inserted and removed if applicable (in the case of non-absorbable stitches). Receives: Other: Product gel RV3895A | |
| Group 2A | Children/adolescents with post-burn scar(s). Receives: Other: Product gel RV3895A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical aspect of scar(s) compared to normal skin by the investigator
The investigator assessed the physical appearance of the studied scar(s) in comparison to normal skin using the "POSAS Observer Scale" (Patient and Observer Scar Assessment Scale)
Measured: Day 1, Day 22, Day 85, and Day 169
Physical and functional aspect of scar(s) by the subject
Subjects who were of age to complete the assessment evaluated the physical appearance in comparison to normal skin and the functional appearance of the studied scar(s) using the "POSAS Patient Scale"
Measured: Day 1, Day 22, Day 85, and Day 169, and monthly at home between Visit 2 and Visit4
Soothing effect
The subject/parent(s) or legal guardian(s) evaluated the soothing effect using a Numerical Rating Scale (NRS) to assess discomfort over the past 3 days (except for the evaluation at Day 1 after application) from 0 (no discomfort) to 10 (severe discomfort)
Measured: at Day 1 (before and after product application), Day 22, Day 85, and Day 169, and monthly at home between Visit 2 and Visit 4.
Inflammatory aspect of scar
The investigator evaluated the inflammatory aspect of the scar using the vitropression test
Measured: at Day 1, Day 22, Day 85, and Day 169
Evolution of scar aspect compared to Day 1
The investigator assessed the evolution of the scar's appearance compared to D1 based on all parameters evaluated in the study using a dynamic Investigator's Global Assessment (IGA) scale ranging from -1 (worsening), 0 (no change), 1 (slight improvement), 2 (clear improvement), 3 (very clear improvement)
Measured: at Day 22, Day 85, and Day 169
Overall satisfaction with Test product (Investigator's assessment)
The investigator assessed overall satisfaction with the product's impact on scar appearance based on usual practice and study parameters using an NRS from 0 (not at all satisfied) to 10 (very satisfied)
Measured: at Day 22, Day 85, and Day 169
Overall satisfaction with Test product (Subject/Parent/Guardian assessment)
The subject/parent(s) or legal guardian(s) assessed overall satisfaction with the product's impact on scar appearance using an NRS from 0 (not at all satisfied) to 10 (very satisfied)
Measured: at Day 22, Day 85, and Day 169
Erythema quantification
Erythema was quantified using chromametry through spectrocolorimetric parameters
Measured: at Day 1, Day 22, Day 85, and Day 169
Dermatology Life Quality Index (DLQI)
Quality of life was assessed by subjects of appropriate age using the Dermatology Life Quality Index (DLQI) questionnaire
Measured: at Day 1, Day 22, Day 85, and Day 169 and monthly at home between Visit 2 and Visit 4
Specific impact of burns on quality of life
For subgroup 1a (Burns) only : evaluated by subjects using the "body image" and "heat sensitivity" subdomains of the Burn Specific Health Scale-Brief (BSHS-B)
Measured: at Day 1, Day 22, Day 85, and Day 169
Visual aspect of the scar through illustrative photographs
Measured: at Day 1, Day 22, Day 85, and Day 169.
The quantity of product used calculated by weighing the tubes
Measured: Between Day 1 and Day 169
Subjective cosmetic acceptability of the product
The subjective cosmetic acceptability of the product was evaluated by the subject/parent(s) or legal guardian(s) using a questionnaire
Measured: at Day 22, Day 85, and Day 169
Recording of adverse events
At each visit, the occurrence of adverse events since the last visit was determined based on spontaneous reports from the subject/parent(s) or legal guardian(s), non-subjective questioning, and clinical evaluations performed by the investigator. All adverse events were recorded in the Case Report Form (CRF)
Measured: at Day 1 (first application of the product on site), Day 22, Day 85, and Day 169
Overall tolerance assessed by the investigator
Overall tolerance was assessed by the investigator considering all individual adverse events and their characteristics, as well as past experience with similar products, using a 5-point scale (Excellent, Very Good, Good, Moderate, Poor)
Measured: at Day 22, Day 85, and Day 169
Compliance
The subject was to record in their subject diary the applications of the study product, as well as any omissions and changes in frequency
Measured: Duration of the study, from Day 1 to Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start23 Nov 2021
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
Why it stopped: Due to recruitment difficulties, the number of subjects included (n=35) was lower than expected (n=60).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ScarsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 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
- NCT07020507
- Sponsor's protocol ID
- RV3895A20210368
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Evaluate the Efficacy of the Cosmetic Product RV3895A on Re-epidermised Scars Following Burns and Surgical Stitches in Adults, Adolescents and Children Over a 6-month Follow-up Period
- ClinicalTrials.gov ID
- NCT07020507
- Acronym / sponsor ID
- RV3895A20210368
- Conditions
- Skin Scars, Post-burn Scars, Post-surgical-stitches Scars
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to recruitment difficulties, the number of subjects included (n=35) was lower than expected (n=60).
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 13 Jun 2025 (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.
This study is exploratory, non-comparative and open-label, conducted in France. It aims to provide insights into the effectiveness and safety of RV3895A - RY1774, potentially benefiting participants by improving scar appearance and quality of life.The aim of this study is to evaluate the efficacy of the cosmetic product RV3895A - RY1774 on re-epidermised scars of the face and body following burns and surgical stitches in adults, adolescents and children over a 6-month follow-up period.
Patients are divided into 2 groups:
- Group 1: adults with:
- Subgroup 1A: adults with post-burn scar(s)
- Subgroup 1C: adults with post-surgical scar(s) requiring stitches to be inserted and removed if applicable (in the case of non-absorbable stitches).
- Group 2: children and/or adolescents including children aged 2 to 7 years inclusive with:
- Subgroup 2A: children/adolescents with post-burn scar(s)
The study consists of 4 visits:
Visit 1: Inclusion (Day 1), Visit 2: Intermediate visit (Day 22), Visit 3: Intermediate visit (Day 85), Visit 4: End-of-study visit (planned or anticipated) (Day 169 )
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1A | – | Other: Product gel RV3895AAdults with post-burn scar(s) |
| Group 1C | – | Other: Product gel RV3895AAdults with post-suture scar(s) requiring stitches to be inserted and removed if applicable (in the case of non-absorbable stitches). |
| Group 2A | – | Other: Product gel RV3895AChildren/adolescents with post-burn scar(s). |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects were recruited from their usual consultations and/or from the centre's registry. If necessary, advertisements were used. Subjects corresponding to the eligibility criteria could receive a telephone call, letter or email offering them to take part in this clinical study.
Key inclusion criteria (29 listed)
- Male or female
- For group 1: subjects aged between 18 to 65 included
- For group 2: subjects aged between 2 to 17 years included
- Subject with superficial scar(s):
- Subject with abundant hairiness on the instrumental measurement area
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Product gel RV3895AThe product is applied twice a day to the scar(s) under study, avoiding all contact with natural orifices (and avoiding ingestion by children in the case of application to the hands in particular). The product is applied using a specific massage technique developed for the product and which is explained by the investigator at visit 1. The product is applied in sufficient quantity to cover the application area. | Other | Group 1A, Group 1C, Group 2A |
Primary outcome
Physical aspect of scar(s) compared to normal skin by the investigator
Time frame: Day 1, Day 22, Day 85, and Day 169
The investigator assessed the physical appearance of the studied scar(s) in comparison to normal skin using the "POSAS Observer Scale" (Patient and Observer Scar Assessment Scale)
Physical and functional aspect of scar(s) by the subject
Time frame: Day 1, Day 22, Day 85, and Day 169, and monthly at home between Visit 2 and Visit4
Subjects who were of age to complete the assessment evaluated the physical appearance in comparison to normal skin and the functional appearance of the studied scar(s) using the "POSAS Patient Scale"
Soothing effect
Time frame: at Day 1 (before and after product application), Day 22, Day 85, and Day 169, and monthly at home between Visit 2 and Visit 4.
The subject/parent(s) or legal guardian(s) evaluated the soothing effect using a Numerical Rating Scale (NRS) to assess discomfort over the past 3 days (except for the evaluation at Day 1 after application) from 0 (no discomfort) to 10 (severe discomfort)
Inflammatory aspect of scar
Time frame: at Day 1, Day 22, Day 85, and Day 169
The investigator evaluated the inflammatory aspect of the scar using the vitropression test
Evolution of scar aspect compared to Day 1
Time frame: at Day 22, Day 85, and Day 169
The investigator assessed the evolution of the scar's appearance compared to D1 based on all parameters evaluated in the study using a dynamic Investigator's Global Assessment (IGA) scale ranging from -1 (worsening), 0 (no change), 1 (slight improvement), 2 (clear improvement), 3 (very clear improvement)
Overall satisfaction with Test product (Investigator's assessment)
Time frame: at Day 22, Day 85, and Day 169
The investigator assessed overall satisfaction with the product's impact on scar appearance based on usual practice and study parameters using an NRS from 0 (not at all satisfied) to 10 (very satisfied)
Overall satisfaction with Test product (Subject/Parent/Guardian assessment)
Time frame: at Day 22, Day 85, and Day 169
The subject/parent(s) or legal guardian(s) assessed overall satisfaction with the product's impact on scar appearance using an NRS from 0 (not at all satisfied) to 10 (very satisfied)
Erythema quantification
Time frame: at Day 1, Day 22, Day 85, and Day 169
Erythema was quantified using chromametry through spectrocolorimetric parameters
Dermatology Life Quality Index (DLQI)
Time frame: at Day 1, Day 22, Day 85, and Day 169 and monthly at home between Visit 2 and Visit 4
Quality of life was assessed by subjects of appropriate age using the Dermatology Life Quality Index (DLQI) questionnaire
Specific impact of burns on quality of life
Time frame: at Day 1, Day 22, Day 85, and Day 169
For subgroup 1a (Burns) only : evaluated by subjects using the "body image" and "heat sensitivity" subdomains of the Burn Specific Health Scale-Brief (BSHS-B)
Visual aspect of the scar through illustrative photographs
Time frame: at Day 1, Day 22, Day 85, and Day 169.
The quantity of product used calculated by weighing the tubes
Time frame: Between Day 1 and Day 169
Subjective cosmetic acceptability of the product
Time frame: at Day 22, Day 85, and Day 169
The subjective cosmetic acceptability of the product was evaluated by the subject/parent(s) or legal guardian(s) using a questionnaire
Recording of adverse events
Time frame: at Day 1 (first application of the product on site), Day 22, Day 85, and Day 169
At each visit, the occurrence of adverse events since the last visit was determined based on spontaneous reports from the subject/parent(s) or legal guardian(s), non-subjective questioning, and clinical evaluations performed by the investigator. All adverse events were recorded in the Case Report Form (CRF)
Overall tolerance assessed by the investigator
Time frame: at Day 22, Day 85, and Day 169
Overall tolerance was assessed by the investigator considering all individual adverse events and their characteristics, as well as past experience with similar products, using a 5-point scale (Excellent, Very Good, Good, Moderate, Poor)
Compliance
Time frame: Duration of the study, from Day 1 to Day 169
The subject was to record in their subject diary the applications of the study product, as well as any omissions and changes in frequency
Results and safety
The study was stopped early (reason given: Due to recruitment difficulties, the number of subjects included (n=35) was lower than expected (n=60).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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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?
An observational study of Skin Scars and Post-burn Scars, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
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 29 inclusion and 0 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: stopped early, as of the sponsor's last update on 13 Jun 2025. 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 France. 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 was stopped early (reason given: Due to recruitment difficulties, the number of subjects included (n=35) was lower than expected (n=60).). Results are not available in the source record.
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?
Physical aspect of scar(s) compared to normal skin by the investigator (time frame: Day 1, Day 22, Day 85, and Day 169). The study lists 16 primary outcomes in all. 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 13 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.