Clinical trial NCT06268496: Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperpigmentation
Keywords: facial hyperpigmentation
melasma
acne induced PIHP
solar lentigo
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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:

* 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.

Eligibility criteria: Inclusion Criteria:

* all phototypes
* only one of the following pigmentary conditions on the face: epidermal or mixed, mild to moderate melasma; mild to moderate acne-induced PIHP; solar lentigo
* female patient of childbearing potential must use one of the reliable methods of contraception and agree not to change it during the study
* patient agreeing not to be exposed to ultraviolet radiation (UV), natural (sun) or artificial (tanning salon), during the study

Exclusion Criteria:

* female patient who gave birth less than 3 months prior to Day 0, who is pregnant, breast-feeding or who plans to become pregnant during the study
* male patient with beard or facial hair, which would interfere with clinical evaluation or clinical procedure baseline)
* patient with any inflammatory dermatosis of the face such as seborrheic dermatitis, rosacea etc.
* severe melasma, dermal melasma
* patient with facial pigmentary disorders other than those described in inclusion criteria
* patient who has used topical depigmenting agents such as hydroquinone and derivatives, glycolic acid, kojic acid, retinoids and derivatives, azelaic acid, niacinamide within 1 month prior to Day 0/Baseline visit
* patient who has used systemic treatments such as tranexamic acid and oral melatonin within 1 month prior to Day 0/Baseline visit;
* patient who has used drugs inducing pigmentation such as tetracyclines, fluoroquinolones, antiepileptics within 1 month prior to Day 0/Baseline visit

Primary outcomes:
measure: IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)
timeFrame: from baseline to Day84
measure: modified Melasma Area and Severity Index (mMASI) for patients with melasma
timeFrame: from baseline to Day84
measure: Post-Acne Hyperpigmentation Index (PAHPI)
timeFrame: from baseline to Day84
measure: solar lentigo pigmentation scale
timeFrame: from baseline to Day84
Secondary outcomes:
measure: colorimetry measurements
timeFrame: from baseline to Day84
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin Instituto da Pele Ltda
Study officials:
affiliation: Medcin Instituto da Pele Ltda
name: Sergio Schalka
role: PRINCIPAL_INVESTIGATOR
References: