An interventional study of tested product (2039125 03) in Hyperpigmentation, sponsored by Cosmetique Active International. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Cosmetique Active International (part of L'Oréal) · Not applicable, Interventional, and Other
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.
Hyperpigmentation is a common skin condition in which the colour 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 before/after comparisons.
This clinical trial is conducted in accordance with the protocol, the HELSINKI declaration (1964) and subsequent amendments, and/or the International Council on Harmonization (ICH) Good Clinical Practices (GCP)/ and in compliance with applicable regulatory requirements.
Statistical Analysis:
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 (i.e. 60 patients in total) was considered sufficient to meet the study objective.
127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.
This study's planned enrollment of 60 is above the median of 32 across 113 interventional studies indexed under Hyperpigmentation.
Browse Hyperpigmentation studies →Cosmetique Active International is the lead sponsor of 55 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
adult patients suffering from mild to moderate melasma (Investigator's Global Assessment (IGA) 1 or 2)
Other: tested product (2039125 03)
adult patients suffering from mild to moderate acne-induced PIHP (IGA 1 or 2) without active acne (i.e., less than 10 inflammatory lesions)
Other: tested product (2039125 03)
adult patients suffering from solar lentigo with a pigmentation score \> 5
Other: tested product (2039125 03)
application twice a day of the tested product (in the morning and evening) and a sunscreen (in the morning and at midday) to the face for 3 months
IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)
the hyperpigmentation is measured on a scale from 0 (cleared, almost cleared) to 3 (markedly darker than the surrounding normal skin)
Time frame: from baseline to Day84
modified Melasma Area and Severity Index (mMASI) for patients with melasma
the mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar and chin); area of involvement for each region (using a scale from 0 to 6): darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 6)
Time frame: from baseline to Day 84
Post-Acne Hyperpigmentation Index (PAHPI)
The PAHPI score is the sum of all 3 weighted scores: median lesion size (from 2 \[\< 3mm\] to 8 \[\> 10mm\], median lesion intensity (from 3 \[slightly darker than surrounding skin\] to 9 \[significantly darker than surrounding skin\] and number of lesions (from 1 \[1-15\] to 5 \[\> 60\]. Total score ranges from 6 to 22.
Time frame: from baseline to Day 84
colorimetry measurements
skin color is measured using the L\*a\*b\* color space (L\* represents lightness, a\* its position between green and red, b\* its position between blue and yellow).
Time frame: from baseline to Day84
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