Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperpigmentation
• Intervention / Treatment: Other: tested product

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 or external factors such as genetic predisposition, hormonal changes, inflammation, acne, ultraviolet (UV) exposure.

Typical hyperpigmentation disorders include post-inflammatory hyperpigmentation, melasma and solar lentigos.

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 will be analyzed using a mixed-effect model. This model includes Time and baseline as fixed effects. Patient will be added as random effect. The comparisons between post-baseline time-point and baseline will be performed whatever the interaction results using a Dunnett adjustment. Degrees of freedom for the comparisons will be approximated by the Kenward-Roger method.
• Safety analysis: No statistical analysis will be performed on safety. The data will be presented descriptively.

Categorical data will be summarized using the number and percentage of patients in each category. Continuous data will be 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 24 patients in each group was considered sufficient to meet the study objective.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • COSDERMA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 with a pigmentation
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mild to moderate melasma; adult patients suffering from mild to moderate melasma (Investigator's Global Assessment (IGA) 1 or 2)	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
Experimental: solar lentigo; adult patients suffering from solar lentigo with a pigmentation score > 5	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
Experimental: 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)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGA score for patients with melasma or post-acne post-inflammatory hyperpigmentation (PIHP)	the hyperpigmentation is measured on a scale from 0 (cleared, almost cleared) to 3 (Severe (Markedly darker than the surrounding normal skin))	from baseline to Day84
modified Melasma Area 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 4)	from baseline to Day 84
Post-Acne Hyper Pigmentation Index (PAHPI)	The PAHPI total score is the sum of all 3 weighted scores: medial 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.	from baseline to Day 84
solar lentigo pigmentation scale	the solar lentigo pigmentation scale evaluates the pigmentation using the following scale: form 0 (no pigmentation) to 10 (brown+).	from baseline to Day84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	from baseline to Day84

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Principal Investigator: Min HU, Laboratoire Cosderma

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Actual): March 5, 2024
• Study Completion (Actual): March 5, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: melasma; facial hyperpigmentation; acne induced PIHP; solar lentigo
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation
• Other Study ID Numbers: LRP23021-B serum

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No