Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06268496
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-01-25
Brief Title:
Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins
Sponsor:
Cosmetique Active International
Organization:
Cosmetique Active International
Study Overview
Official Title:
Evaluation of the Efficacy and Tolerability of the Tested Formula BID After 3 Months in the Treatment of Facial Hyperpigmentation of 3 Origins Melasma Acne Induced Post-Inflammatory Hyperpigmentation and Solar Lentigo
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the efficacy cosmetic acceptability and improvement of the stigmatization of the tested product 2039125 03 used bis in die BID for 3 months in adult patients suffering from mild to moderate melasma or mild to moderate acne induced post-inflammatory hyperpigmentation or solar lentigo
Detailed Description:
Hyperpigmentation is a common skin condition in which the color of the skin becomes darker These changes result from an excess of melanin production distribution or transport which can be caused by various internal and external factors such as genetic predisposition hormonal changes inflammation acne ultraviolet UV exposure
Typical hyperpigmentation disorders include post-inflammatory hyperpigmentation melasma and solar lentigines
This open single-centre three-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial hyperpigmentation and used under normal conditions of use with beforeafter comparisons
This clinical trial is conducted in accordance with the protocol the HELSINKI declaration 1964 and subsequent amendments andor the International Council on Harmonization ICH Good Clinical Practices GCP and in compliance with applicable regulatory requirements
Statistical Analysis
Efficacy Analysis in each group the quantitative parameters are analyzed using a mixed-effect model This model includes Time and baseline as fixed effects Patient are added as random effect The comparisons between post-baseline time-point and baseline are performed whatever the interaction results using a Dunnett adjustment Degrees of freedom for the comparisons are approximated by the Kenward-Roger method
Safety Analysis no statistical analysis will be performed on safety The data are presented descriptively
Categorical data are summarized using the number and percentage of patients in each category Continuous data are summarized using the arithmetic mean Standard Deviation SD Q1 Q3 minimum median and maximum values
Regarding the sample size determination there was no formal calculation A number of 20 patients in each group was considered sufficient to meet the study objective
Typical hyperpigmentation disorders include post-inflammatory hyperpigmentation melasma and solar lentigines
This open single-centre three-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial hyperpigmentation and used under normal conditions of use with beforeafter comparisons
This clinical trial is conducted in accordance with the protocol the HELSINKI declaration 1964 and subsequent amendments andor the International Council on Harmonization ICH Good Clinical Practices GCP and in compliance with applicable regulatory requirements
Statistical Analysis
Efficacy Analysis in each group the quantitative parameters are analyzed using a mixed-effect model This model includes Time and baseline as fixed effects Patient are added as random effect The comparisons between post-baseline time-point and baseline are performed whatever the interaction results using a Dunnett adjustment Degrees of freedom for the comparisons are approximated by the Kenward-Roger method
Safety Analysis no statistical analysis will be performed on safety The data are presented descriptively
Categorical data are summarized using the number and percentage of patients in each category Continuous data are summarized using the arithmetic mean Standard Deviation SD Q1 Q3 minimum median and maximum values
Regarding the sample size determination there was no formal calculation A number of 20 patients in each group was considered sufficient to meet the study objective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None