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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)
Study 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 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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
mild to moderate melasma
adult patients suffering from mild to moderate melasma (Investigator's Global Assessment (IGA) 1 or 2)
Intervention: tested product (Other)
mild to moderate acne induced PIHP
adult patients suffering from mild to moderate acne-induced PIHP (IGA 1 or 2) without active acne (i.e. less than 10 inflammatory lesions)
Intervention: tested product (Other)
solar lentigo
adult patients suffering from solar lentigo with a pigmentation score > 5
Intervention: tested product (Other)
Outcomes
Primary Outcomes
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 (markedly darker than the surrounding normal skin).
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 (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).
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 (form 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.
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 measurements(from baseline to Day84)
- stigmatization questionnaire(from baseline to Day84)
- local tolerability assessment by the patient(Day28; Day56; Day84)
- local tolerability assessment by the investigator(Day28; Day56; Day84)