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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperpigmentation
- Sponsor
- Cosmetique Active International
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- modified Melasma Area and Severity Index (mMASI) for patients with melasma
- Status
- Recruiting
- Last Updated
- last year
Overview
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 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: * 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.
Investigators
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
Outcomes
Primary Outcomes
modified Melasma Area and Severity Index (mMASI) for patients with melasma
Time Frame: from baseline to Day 84
The mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar, chin); area of involvement for each region (using a scale from 0 to 6); darkness compared to the surrounding normal skin for each area (using a scale from 0 to 6.
Post-Acne Hyperpigmentation Index (PAHPI)
Time Frame: from baseline to Day 84
The PAHPI total score is the sum of all 3 weighted scores: median lesion size (from 2 \[\< 3mm\] to 8 \[\> 10 mm\], 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.
IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)
Time Frame: from baseline to Day84
the hyperpigmentation is measured on a scale from 0 (cleared, almost cleared) to 3 (severe (markedly darker than the surrounding skin)
solar lentigo pigmentation scale
Time Frame: from baseline to Day84
the solar lentigo pigmentation scale evaluates the pigmentation using the following scale: from 0 (no pigmentation) to 10 (brown+).
Secondary Outcomes
- colorimetry measures(from baseline to Day84)