Effectiveness and Tolerance of Cicaplast Baume B5 After Superficial CO2 Laser Resurfacing
NCT ID: NCT06467032
Last Updated: 2024-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2023-01-16
2023-04-21
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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superficial CO2 laser resurfacing
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.
superficial CO2 laser resurfacing
Application of the tested product and comparators on the laser treated side of the back
Laser untreated side
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.
Laser untreated side
Application of the tested product and comparators on the laser untreated (control) side of the back
Interventions
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superficial CO2 laser resurfacing
Application of the tested product and comparators on the laser treated side of the back
Laser untreated side
Application of the tested product and comparators on the laser untreated (control) side of the back
Eligibility Criteria
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Inclusion Criteria
* subjects with normal clinical examination and medical history compatible with the study
Exclusion Criteria
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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Cosmetique Active International
INDUSTRY
Responsible Party
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Principal Investigators
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Catherine Queille-Roussel
Role: PRINCIPAL_INVESTIGATOR
Centre de Pharmacologie Clinique Applique a la Dermatologie
Locations
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CPCAD
Nice, , France
Countries
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Other Identifiers
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LRP21007 Cicaplast
Identifier Type: -
Identifier Source: org_study_id
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