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

March 16, 2024 updated by: Cosmetique Active International

Evaluation of the Efficacy and Tolerability of the Tested Formula 2039125 03 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

Recruiting

Conditions

Intervention / Treatment

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 (i.e. 60 patients in total) was considered sufficient to meet the study objective.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
      • Lisboa, Portugal
        • Recruiting
        • PhDTrials Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • female patient of childbearing potential must use one of the reliable methods of contraception and agree not to change it 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 (2039125 03)
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 (2039125 03)
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 (2039125 03)
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 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)
from baseline to Day84
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 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)
from baseline to Day 84
Post-Acne Hyperpigmentation Index (PAHPI)
Time Frame: from baseline to Day 84
The PAHPI score is the sum of all 3 weighted scores: median lesion size (from 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.
from baseline to Day 84

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
colorimetry measurements
Time Frame: from baseline to Day84
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

This is where you will find people and organizations involved with this study.

Sponsor

Cosmetique Active International

Investigators

  • Principal Investigator: Pedro Pinto, PhDTrials Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2024

Primary Completion (Estimated)

May 22, 2024

Study Completion (Estimated)

May 22, 2024

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 16, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRP23021-E 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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