Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma

Evaluation of the Efficacy of the Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma

This 6 month, comparative study assesses the benefit of a dermocosmetic regimen (Serum B3 + B3 retinol night cream) for 6 months compared to hydroquinone 4% (the gold standard in hyperpigmentation) followed by the dermocosmetic regimen for 3 months or the Kligman Trio for 3 months followed by the dermocosmetic regimen for 3 months in adult women with melasma on the face.

Study Overview

• Status: Not yet recruiting
• Conditions: Melasma
• Intervention / Treatment: Other: Liftactiv® B3 Serum; Other: Liftactiv® B3 retinol night cream; Other: Sunscreen UVAage® Inter SPF 50+; Other: Mineral 89 cream

Detailed Description

Study objective

1. Assessing the antipigmenting efficacy of the routine (serum B3 + B3 retinol night cream) in women with melasma.
2. Evaluation of Kligman Trio (KT) (Vitacid Plus) compared to the routine (serum B3 + B3 retinol night cream)
3. Evaluation of Hydroquinone 4% (HQ 4%) compared to the routine (serum B3 + B3 retinol night cream).
4. Assessment of the routine maintenance with SERUM B3 + retinol B3 night cream after 3 months of use of Klingman Trio (KT)(Vitacid plus) and HQ4%

Primary endpoint:

o Improvement of mMASI and MASI

Secondary endpoints:

• Improvement of Physician Global Assessment IGA for melasma
• Improvements on clinical parameters such as fine lines, skin tone, radiance, skin texture and skin elasticity evaluated by the investigator.
• Global efficacy by the subject and by the investigator (Physician's Global assessment)
• Global tolerance
• Safety
• Cosmetic acceptability
• Improvement of Quality of life (MelasQOL)
• Exposome questionnaire
• Questionnaire on hormonal status
• Improvement of the morphological and structural characteristics of ageing skin - By confocal microscopy (15 subjects per subgroup)
• Clinical scoring: hyperpigmentation scale
• Standard facial pictures with Colorface®
• Chromameter® measurements (target lesion assessment compared to non lesional surrounding skin)
• Tewameter® measurements
• Corneometer® measurements

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Deloche-Bensmain, PhD; Phone Number: +33 7 76 11 27 98; Email: claire.deloche-bensmaine@loreal.com
• Study Contact Backup: Name: Marianna Feiges; Email: mariana.feiges@loreal.com

Study Locations

• Brazil
  • Rio de Janeiro, Brazil
    • CIDP
    • Contact: Alessandro NASCIMENTO
    • Principal Investigator: Renato Moura, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 18-65 years
• Phototype II-V
• 50% with sensitive skin (declarative);
• Subjects should be affected by well defined symmetrical (on both sides of the face) epidermal melasma (clinically diagnosed under Wood's light examination) lasting since more than a year

Exclusion Criteria:

• Subjects under topical or systemic retinoids;
• Subjects having used topical tretinoin within 3 months or topical hydroquinone within 6 months prior to inclusion;
• Subjects under systemic immunosuppressants and considered immune compromised
• Subjects under active treatment of melasma (including topicals or procedures) within the last 3 months
• Pregnant women and/or breastfeeding women
• Subjects with a recent change in contraception (since less than 6 months);
• Subjects known allergy to any component of tested product;
• Subjects not presenting with the conditions needed to comply with the protocol;
• Subjects without any other dermatological conditions on the face
• Subject under menopause phase with hormonal replace therapy
• Subjects in the initial phase, change or discontinuation of hormonal treatment (estroprogesterone, cyproteron acetate, androgenic...) in the last 3 months;
• Subjects currently using any medication, which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
• Subjects unable to give their informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; dermocosmetic regimen consisting in Liftactiv(® B3 serum + Liftactiv® B3 retinol night cream (all Vichy Laboratoires, France) for 6 months + Mineral 89 cream + Sunscreen UVAage Inter SPF 50+	Other: Liftactiv® B3 Serum; In Group 1: Application once daily for 6 months, 3-4 drops twice a day (morning before the sunscreen and evening) In Group 2 and Group 3: Application once daily, 3-4 drops twice a day (morning before the sunscreen and evening) for 3 months following HQ4% or Kligman Trio treatment.; Other: Liftactiv® B3 retinol night cream; In Group 1: Application once daily (morning) for 6 months In Group 2 and Group 3: During week 1, apply 2 evenings/week. During week 2, apply every other evening. During week 3, apply every evening. During nights when retinol night cream is not applied, replace with Mineral 89 cream for 3 months following HQ4% or Kligman Trio treatment.; Other: Sunscreen UVAage® Inter SPF 50+; twice daily (morning and beginning of the afternoon); Other: Mineral 89 cream; 2 drops in the morning before sunscreen application for 6 months
Active Comparator: Group 2; hydroquinone 4% (HQ4%, Hydroquinona 40 mg/g, Germed, Brazil) for 3 months followed by the dermocosmetic regimen (Liftactiv(® B3 serum + Liftactiv® B3 retinol night cream + Mineral 89 cream + Sunscreen UVAage Inter SPF 50+) for 3 months	Other: Liftactiv® B3 Serum; In Group 1: Application once daily for 6 months, 3-4 drops twice a day (morning before the sunscreen and evening) In Group 2 and Group 3: Application once daily, 3-4 drops twice a day (morning before the sunscreen and evening) for 3 months following HQ4% or Kligman Trio treatment.; Other: Liftactiv® B3 retinol night cream; In Group 1: Application once daily (morning) for 6 months In Group 2 and Group 3: During week 1, apply 2 evenings/week. During week 2, apply every other evening. During week 3, apply every evening. During nights when retinol night cream is not applied, replace with Mineral 89 cream for 3 months following HQ4% or Kligman Trio treatment.; Other: Sunscreen UVAage® Inter SPF 50+; twice daily (morning and beginning of the afternoon); Other: Mineral 89 cream; 2 drops in the morning before sunscreen application for 6 months
Active Comparator: Group 3; Combination of hydroquinone, resorcinol corticosteroid (Kligman Trio, Vitacid Plus Cream, Claredor Brazil) for 3 months followed by the dermocosmetic regimen (Liftactiv(® B3 serum + Liftactiv® B3 retinol night cream + Mineral 89 cream + Sunscreen UVAage Inter SPF 50+) for 3 months	Other: Liftactiv® B3 Serum; In Group 1: Application once daily for 6 months, 3-4 drops twice a day (morning before the sunscreen and evening) In Group 2 and Group 3: Application once daily, 3-4 drops twice a day (morning before the sunscreen and evening) for 3 months following HQ4% or Kligman Trio treatment.; Other: Liftactiv® B3 retinol night cream; In Group 1: Application once daily (morning) for 6 months In Group 2 and Group 3: During week 1, apply 2 evenings/week. During week 2, apply every other evening. During week 3, apply every evening. During nights when retinol night cream is not applied, replace with Mineral 89 cream for 3 months following HQ4% or Kligman Trio treatment.; Other: Sunscreen UVAage® Inter SPF 50+; twice daily (morning and beginning of the afternoon); Other: Mineral 89 cream; 2 drops in the morning before sunscreen application for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
antipigmenting assessment	Melasma Area Severity Index (MASI)	Day 84
antipigmenting assessment	modified Melasma Area Severity Index (mMASI)	Day 84
antipigmenting assessment	Melasma Area Severity Index(MASI)	Day 168
antipigmenting assessment	modified Melasma Area Severity Index (mMASI)	Day 168

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
antipigmenting assessment	Melasma Area Severity Index(MASI)	Day-28
antipigmenting assessment	modified Melasma Area Severity Index (mMASI)	Day-28
antipigmenting assessment	Melasma Area Severity Index(MASI)	baseline
antipigmenting assessment	modified Melasma Area Severity Index (mMASI)	baseline
antipigmenting assessment	Melasma Area Severity Index(MASI)	Day 28
antipigmenting assessment	modified Melasma Area Severity Index (mMASI)	Day 28
antipigmenting assessment	Melasma Area Severity Index(MASI)	Day 56
antipigmenting assessment	modified Melasma Area Severity Index (mMASI)	Day 56
antipigmenting assessment	Melasma Area Severity Index(MASI)	Day 112
antipigmenting assessment	modified Melasma Area Severity Index (mMASI)	Day 112
antipigmenting assessment	Melasma Area Severity Index(MASI)	Day 140
antipigmenting assessment	modified Melasma Area Severity Index (mMASI)	Day 140
Investigator Global Assessment (IGA) assessment	IGA score	Day -28
Investigator Global Assessment (IGA) assessment	IGA score	baseline
Investigator Global Assessment (IGA) assessment	IGA score	Day 28
Investigator Global Assessment (IGA) assessment	IGA score	Day 56
Investigator Global Assessment (IGA) assessment	IGA score	Day 84
Investigator Global Assessment (IGA) assessment	IGA score	Day 112
Investigator Global Assessment (IGA) assessment	IGA score	Day 140
Investigator Global Assessment (IGA) assessment	IGA score	Day 168
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)	scores 0 to 5	Day -28
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)	scores 0 to 5	baseline
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)	scores 0 to 5	Day 28
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)	scores 0 to 5	Day 84
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)	scores 0 to 5	Day 168
Clinical scoring hyperpigmentation	scale 0 to 10	baseline
Clinical scoring hyperpigmentation	scale 0 to 10	Day 28
Clinical scoring hyperpigmentation	scale 0 to 10	Day 56
Clinical scoring hyperpigmentation	scale 0 to 10	Day 84
Clinical scoring hyperpigmentation	scale 0 to 10	Day 112
Clinical scoring hyperpigmentation	scale 0 to 10	Day 140
Clinical scoring hyperpigmentation	scale 0 to 10	Day 168
Clinical scoring target lesion comparing to surrounding skin	scale 0 to 10	baseline
Clinical scoring target lesion comparing to surrounding skin	scale 0 to 10	Day 28
Clinical scoring target lesion comparing to surrounding skin	scale 0 to 10	Day 56
Clinical scoring target lesion comparing to surrounding skin	scale 0 to 10	Day 84
Clinical scoring target lesion comparing to surrounding skin	scale 0 to 10	Day 112
Clinical scoring target lesion comparing to surrounding skin	scale 0 to 10	Day 140
Clinical scoring target lesion comparing to surrounding skin	scale 0 to 10	Day 168
Subject global efficay rating	rating	Day 28
Subject global efficay rating	rating	Day 56
Subject global efficay rating	rating	Day 84
Subject global efficay rating	rating	Day 112
Subject global efficay rating	rating	Day 140
Subject global efficay rating	rating	Day 168
Investigator global efficay rating	rating	Day 28
Investigator global efficay rating	rating	Day 56
Investigator global efficay rating	rating	Day 84
Investigator global efficay rating	rating	Day 112
Investigator global efficay rating	rating	Day 140
Investigator global efficay rating	rating	Day 168
Cosmetic acceptability	questionnaire	Day 28
Cosmetic acceptability	questionnaire	Day 56
Cosmetic acceptability	questionnaire	Day 84
Cosmetic acceptability	questionnaire	Day 112
Cosmetic acceptability	questionnaire	Day 140
Cosmetic acceptability	questionnaire	Day 168
Evolution of quality of life	MelasQoL	Day -28
Evolution of quality of life	MelasQoL	baseline
Evolution of quality of life	MelasQoL	Day 28
Evolution of quality of life	MelasQoL	Day 56
Evolution of quality of life	MelasQoL	Day 84
Evolution of quality of life	MelasQoL	Day 112
Evolution of quality of life	MelasQoL	Day 140
Evolution of quality of life	MelasQoL	Day 156
images	Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.	baseline
images	Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.	Day 28
images	Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.	Day 56
images	Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.	Day 84
images	Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.	Day 112
images	Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.	Day 140
images	Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.	Day 168
Skin quality	Chromameter, Individual Typology Angle (ITA)	baseline
Skin quality	Chromameter, Individual Typology Angle (ITA)	Day 28
Skin quality	Chromameter, Individual Typology Angle (ITA)	Day 56
Skin quality	Chromameter, Individual Typology Angle (ITA)	Day 84
Skin quality	Chromameter, Individual Typology Angle (ITA)	Day 112
Skin quality	Chromameter, Individual Typology Angle (ITA)	Day 140
Skin quality	Chromameter, Individual Typology Angle (ITA)	Day 168
transepidermal water loss	Tewameter	baseline
transepidermal water loss	Tewameter	Day 28
transepidermal water loss	Tewameter	Day 56
transepidermal water loss	Tewameter	Day 84
transepidermal water loss	Tewameter	Day 112
transepidermal water loss	Tewameter	Day 140
transepidermal water loss	Tewameter	Day 168
skin hydration	Corneometer	baseline
skin hydration	Corneometer	Day 28
skin hydration	Corneometer	Day 56
skin hydration	Corneometer	Day 84
skin hydration	Corneometer	Day 112
skin hydration	Corneometer	Day 140
skin hydration	Corneometer	Day 168
confocal	confocal measurements (15 subjects)	baseline
confocal	confocal measurements (15 subjects)	Day 84
confocal	confocal measurements (15 subjects)	Day 168
exposome questionnaire	questionnaire	baseline
Melasma status	questionnaire	baseline
adverse events	reporting	baseline
adverse events	reporting	Day 28
adverse events	reporting	Day 56
adverse events	reporting	Day 84
adverse events	reporting	Day 112
adverse events	reporting	Day 140
adverse events	reporting	Day 168

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Study Director: Claire Deloche-Bensmain, PhD, La Roche Posayl Laboratoires Dermatologiques

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: melasma; hyperpigmentation
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Micronutrients; Vitamins; Radiation-Protective Agents; Vitamin A; Sunscreening Agents
• Other Study ID Numbers: VCY23-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the protocol will be shared by the sponsor upon reasonable request for one year after the end of the study
• IPD Sharing Time Frame: one after finishing study
• IPD Sharing Access Criteria: upon request to the sponsor
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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