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

NCT ID: NCT06320314

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2024-05-22

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

Conditions

Hyperpigmentation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

mild to moderate melasma

adult patients suffering from mild to moderate melasma (Investigator's Global Assessment (IGA) 1 or 2)

Group Type: EXPERIMENTAL

tested product (2039125 03)

Intervention Type: OTHER

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

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)

Group Type: EXPERIMENTAL

tested product (2039125 03)

Intervention Type: OTHER

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

solar lentigo

adult patients suffering from solar lentigo with a pigmentation score \> 5

Group Type: EXPERIMENTAL

tested product (2039125 03)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cosmetique Active International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Pinto

Role: PRINCIPAL_INVESTIGATOR

PhDTrials center

Locations

PhDTrials Center

Lisbon, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Pedro Pinto

Role: CONTACT

geral@phdtrials.com

+351 216034267 ext. 501

Facility Contacts

Pedro Pinto

Role: primary

geral@phdtrials.com

+351 216034267 ext. 501

Other Identifiers

LRP23021-E serum

Identifier Type: -

Identifier Source: org_study_id