Efficacy and Tolerability of Tested Formula After 3 Months of 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

Overview

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.

Interventions

• Other tested product
  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

Primary outcome measures

• IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP) [Time frame: from baseline to Day84]
• modified Melasma Area and Severity Index (mMASI) for patients with melasma [Time frame: from baseline to Day 84]
• Post-Acne Hyperpigmentation Index (PAHPI) [Time frame: from baseline to Day 84]
• solar lentigo pigmentation scale [Time frame: from baseline to Day84]

Secondary outcome measures (1)

• colorimetry measures [Time frame: from baseline to Day84]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Singapore · 1 center

• National Skin Care Centre — Singapore

Identifiers

NCT: NCT06253468 · LRP23021-C serum

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗