Wound HealNCT06467032
Effectiveness and Tolerance of Cicaplast Baume B5 After Superficial CO2 Laser Resurfacing
A study testing superficial CO2 laser resurfacing and Laser untreated side in people with Wound Heal, run by Cosmetique Active International at 1 site in France.
Trial summary
This monocentric, double-blinded, randomized with intra-individual comparisons study is an interventional cosmetic study. The objective is to evaluate the effectiveness of a new formulation on the re-epithelialization kinetic after superficial CO2 laser dermabrasion in comparison to an untreated area. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- superficial CO2 laser resurfacing and Laser untreated side
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2023to 21 Apr 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- phototype II and III on the Fitzpatrick scale
- subjects with normal clinical examination and medical history compatible with the study
Who cannot join
- subject with underlying pathology that may interfere with the interpretation of the study results (dermatological history of psoriasis, eczema, urticaria... or suspicion/history of allergies to cosmetics), skin abnormality (scars, excessive hair growth, tattoos...) in the test areas (back, midline), systemic pathology
- subject with excessive exposure to natural (sun) or artificial (tanning salon) ultraviolet light (UV) 4 weeks prior to the initial visit or who anticipates such exposure during the study
- subject who has taken systemic treatment for more than 5 days in the month prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness and Tolerance of Cicaplast Baume B5 on the Re-epithelialization Kinetic After Superficial CO2 Laser Resurfacing
This monocentric, double-blinded, randomized with intra-individual comparisons study is an interventional cosmetic study.
The objective is to evaluate the effectiveness of a new formulation on the re-epithelialization kinetic after superficial CO2 laser dermabrasion in comparison to an untreated area.
Read the detailed description
This clinical trial is conducted in accordance with the protocol, the Helsinki declaration (1964) and subsequent amendments, and the International Council on Harmonisation (ICH) Good Clinical Practice (GCP), and in compliance with applicable regulatory requirements.
Statistical method: analysis will be performed using R software version 4.0.2. or higher. All statistical tests will be two-sided and at the 5% level of significance. Normality tests will be at the 1% level of significance (Shapiro-Wilk). All efficacy evaluation will be done on the Per Protocol Set.
The categorical variables are summarized by frequency and percentage for each response category (N, %). The continuous variables are summarized using means, medians, minimum, maximum, and standard deviations for the data collected at each visit.
Sample size determination: A number of 22 subjects would allow to detect a significant difference of at least of 2 days for complete re-epithelialization score between the treated and untreated areas with a power of 91% at a risk alpha of 0.05 and assuming a common standard deviation of ±2.7 days. Twenty-five (25) subjects will be included in the study to take into account possible dropouts.
- Conditions
- Wound Heal
- Being tested
- superficial CO2 laser resurfacing, Laser untreated side
- Keywords
- re-epithelialization, superficial CO2 laser resurfacing, Cicaplast Baume B5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superficial CO2 laser resurfacingOther
Application of the tested product and comparators on the laser treated side of the back
Laser untreated sideOther
Application of the tested product and comparators on the laser untreated (control) side of the back
| Study group | Role | What they receive |
|---|---|---|
| superficial CO2 laser resurfacing | Experimental | The tested product and comparators are applied twice daily from Day2 to Day18 (except Sundays Day7 and Day14). Each subject receives a total of 30 applications of each tested product. Receives: Other: superficial CO2 laser resurfacing |
| Laser untreated side | Active comparator | The tested product and comparators are applied twice daily from Day2 to Day18 (except Sundays Day7 and Day14). Each subject receives a total of 30 applications of each tested product. Receives: Other: Laser untreated side |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing assessment by the Investigator (number of days for complete re-epithelialization)
assessment on a 6-point scale: 0 (No healing); 1 (Weak healing: <25% of the lesion area); 2 (Partial healing: between 25 and 50% of the lesion area); 3 (Significant healing: between 50 and 75% of the lesion area); 4 (Almost complete healing: >75% of the lesion area); 5 (Complete healing).
Measured: from baseline to Day19
Secondary outcomes (1)
wound healing assessment by the Investigator (number of days for 25%, 50% and 75% re-epithelialization)
assessment on a 6-point scale: 0 (No healing); 1 (Weak healing: <25% of the lesion area); 2 (Partial healing: between 25 and 50% of the lesion area); 3 (Significant healing: between 50 and 75% of the lesion area); 4 (Almost complete healing: >75% of the lesion area); 5 (Complete healing).
Measured: from baseline to Day19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start16 Jan 2023
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Queille-Roussel, Principal investigator, Centre de Pharmacologie Clinique Applique a la Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467032
- Sponsor's protocol ID
- LRP21007 Cicaplast
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 20 Jun 2024
- 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 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Tolerance of Cicaplast Baume B5 on the Re-epithelialization Kinetic After Superficial CO2 Laser Resurfacing
- ClinicalTrials.gov ID
- NCT06467032
- Acronym / sponsor ID
- LRP21007 Cicaplast
- Conditions
- Wound Heal
- Keywords
- re-epithelialization, superficial CO2 laser resurfacing, Cicaplast Baume B5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 20 Jun 2024 (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 monocentric, double-blinded, randomized with intra-individual comparisons study is an interventional cosmetic study.
The objective is to evaluate the effectiveness of a new formulation on the re-epithelialization kinetic after superficial CO2 laser dermabrasion in comparison to an untreated area.
Detailed description
This clinical trial is conducted in accordance with the protocol, the Helsinki declaration (1964) and subsequent amendments, and the International Council on Harmonisation (ICH) Good Clinical Practice (GCP), and in compliance with applicable regulatory requirements.
Statistical method: analysis will be performed using R software version 4.0.2. or higher. All statistical tests will be two-sided and at the 5% level of significance. Normality tests will be at the 1% level of significance (Shapiro-Wilk). All efficacy evaluation will be done on the Per Protocol Set.
The categorical variables are summarized by frequency and percentage for each response category (N, %). The continuous variables are summarized using means, medians, minimum, maximum, and standard deviations for the data collected at each visit.
Sample size determination: A number of 22 subjects would allow to detect a significant difference of at least of 2 days for complete re-epithelialization score between the treated and untreated areas with a power of 91% at a risk alpha of 0.05 and assuming a common standard deviation of ±2.7 days. Twenty-five (25) subjects will be included in the study to take into account possible dropouts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| superficial CO2 laser resurfacing | Experimental | Other: superficial CO2 laser resurfacingThe tested product and comparators are applied twice daily from Day2 to Day18 (except Sundays Day7 and Day14). Each subject receives a total of 30 applications of each tested product. |
| Laser untreated side | Active comparator | Other: Laser untreated sideThe tested product and comparators are applied twice daily from Day2 to Day18 (except Sundays Day7 and Day14). Each subject receives a total of 30 applications of each tested product. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- phototype II and III on the Fitzpatrick scale
- subjects with normal clinical examination and medical history compatible with the study
Key exclusion criteria (3 listed)
- subject with underlying pathology that may interfere with the interpretation of the study results (dermatological history of psoriasis, eczema, urticaria... or suspicion/history of allergies to cosmetics), skin abnormality (scars, excessive hair growth, tattoos...) in the test areas (back, midline), systemic pathology
- subject with excessive exposure to natural (sun) or artificial (tanning salon) ultraviolet light (UV) 4 weeks prior to the initial visit or who anticipates such exposure during the study
- subject who has taken systemic treatment for more than 5 days in the month prior to inclusion
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 |
|---|---|---|
| superficial CO2 laser resurfacingApplication of the tested product and comparators on the laser treated side of the back | Other | superficial CO2 laser resurfacing |
| Laser untreated sideApplication of the tested product and comparators on the laser untreated (control) side of the back | Other | Laser untreated side |
Primary outcome
wound healing assessment by the Investigator (number of days for complete re-epithelialization)
Time frame: from baseline to Day19
assessment on a 6-point scale: 0 (No healing); 1 (Weak healing: <25% of the lesion area); 2 (Partial healing: between 25 and 50% of the lesion area); 3 (Significant healing: between 50 and 75% of the lesion area); 4 (Almost complete healing: >75% of the lesion area); 5 (Complete healing).
1 secondary outcome
wound healing assessment by the Investigator (number of days for 25%, 50% and 75% re-epithelialization)
Time frame: from baseline to Day19
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 20 Jun 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.
Catherine Queille-Roussel principal investigator
Centre de Pharmacologie Clinique Applique a la Dermatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superficial CO2 laser resurfacing and Laser untreated side in people with Wound Heal, run by Cosmetique Active International 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 2 inclusion and 3 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 20 Jun 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 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 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?
wound healing assessment by the Investigator (number of days for complete re-epithelialization) (time frame: from baseline to Day19). 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 20 Jun 2024.