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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study objective
- Assessing the antipigmenting efficacy of the routine (serum B3 + B3 retinol night cream) in women with melasma.
- Evaluation of Kligman Trio (KT) (Vitacid Plus) compared to the routine (serum B3 + B3 retinol night cream)
- Evaluation of Hydroquinone 4% (HQ 4%) compared to the routine (serum B3 + B3 retinol night cream).
- 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
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
-
-
-
Rio de Janeiro, Brazil
- CIDP
-
Contact:
- Alessandro NASCIMENTO
-
Principal Investigator:
- Renato Moura, MD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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+
|
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.
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.
twice daily (morning and beginning of the afternoon)
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
|
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.
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.
twice daily (morning and beginning of the afternoon)
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
|
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.
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.
twice daily (morning and beginning of the afternoon)
2 drops in the morning before sunscreen application for 6 months
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
antipigmenting assessment
Time Frame: Day 84
|
Melasma Area Severity Index (MASI)
|
Day 84
|
|
antipigmenting assessment
Time Frame: Day 84
|
modified Melasma Area Severity Index (mMASI)
|
Day 84
|
|
antipigmenting assessment
Time Frame: Day 168
|
Melasma Area Severity Index(MASI)
|
Day 168
|
|
antipigmenting assessment
Time Frame: Day 168
|
modified Melasma Area Severity Index (mMASI)
|
Day 168
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
antipigmenting assessment
Time Frame: Day-28
|
Melasma Area Severity Index(MASI)
|
Day-28
|
|
antipigmenting assessment
Time Frame: Day-28
|
modified Melasma Area Severity Index (mMASI)
|
Day-28
|
|
antipigmenting assessment
Time Frame: baseline
|
Melasma Area Severity Index(MASI)
|
baseline
|
|
antipigmenting assessment
Time Frame: baseline
|
modified Melasma Area Severity Index (mMASI)
|
baseline
|
|
antipigmenting assessment
Time Frame: Day 28
|
Melasma Area Severity Index(MASI)
|
Day 28
|
|
antipigmenting assessment
Time Frame: Day 28
|
modified Melasma Area Severity Index (mMASI)
|
Day 28
|
|
antipigmenting assessment
Time Frame: Day 56
|
Melasma Area Severity Index(MASI)
|
Day 56
|
|
antipigmenting assessment
Time Frame: Day 56
|
modified Melasma Area Severity Index (mMASI)
|
Day 56
|
|
antipigmenting assessment
Time Frame: Day 112
|
Melasma Area Severity Index(MASI)
|
Day 112
|
|
antipigmenting assessment
Time Frame: Day 112
|
modified Melasma Area Severity Index (mMASI)
|
Day 112
|
|
antipigmenting assessment
Time Frame: Day 140
|
Melasma Area Severity Index(MASI)
|
Day 140
|
|
antipigmenting assessment
Time Frame: Day 140
|
modified Melasma Area Severity Index (mMASI)
|
Day 140
|
|
Investigator Global Assessment (IGA) assessment
Time Frame: Day -28
|
IGA score
|
Day -28
|
|
Investigator Global Assessment (IGA) assessment
Time Frame: baseline
|
IGA score
|
baseline
|
|
Investigator Global Assessment (IGA) assessment
Time Frame: Day 28
|
IGA score
|
Day 28
|
|
Investigator Global Assessment (IGA) assessment
Time Frame: Day 56
|
IGA score
|
Day 56
|
|
Investigator Global Assessment (IGA) assessment
Time Frame: Day 84
|
IGA score
|
Day 84
|
|
Investigator Global Assessment (IGA) assessment
Time Frame: Day 112
|
IGA score
|
Day 112
|
|
Investigator Global Assessment (IGA) assessment
Time Frame: Day 140
|
IGA score
|
Day 140
|
|
Investigator Global Assessment (IGA) assessment
Time Frame: Day 168
|
IGA score
|
Day 168
|
|
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
Time Frame: Day -28
|
scores 0 to 5
|
Day -28
|
|
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
Time Frame: baseline
|
scores 0 to 5
|
baseline
|
|
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
Time Frame: Day 28
|
scores 0 to 5
|
Day 28
|
|
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
Time Frame: Day 84
|
scores 0 to 5
|
Day 84
|
|
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
Time Frame: Day 168
|
scores 0 to 5
|
Day 168
|
|
Clinical scoring hyperpigmentation
Time Frame: baseline
|
scale 0 to 10
|
baseline
|
|
Clinical scoring hyperpigmentation
Time Frame: Day 28
|
scale 0 to 10
|
Day 28
|
|
Clinical scoring hyperpigmentation
Time Frame: Day 56
|
scale 0 to 10
|
Day 56
|
|
Clinical scoring hyperpigmentation
Time Frame: Day 84
|
scale 0 to 10
|
Day 84
|
|
Clinical scoring hyperpigmentation
Time Frame: Day 112
|
scale 0 to 10
|
Day 112
|
|
Clinical scoring hyperpigmentation
Time Frame: Day 140
|
scale 0 to 10
|
Day 140
|
|
Clinical scoring hyperpigmentation
Time Frame: Day 168
|
scale 0 to 10
|
Day 168
|
|
Clinical scoring target lesion comparing to surrounding skin
Time Frame: baseline
|
scale 0 to 10
|
baseline
|
|
Clinical scoring target lesion comparing to surrounding skin
Time Frame: Day 28
|
scale 0 to 10
|
Day 28
|
|
Clinical scoring target lesion comparing to surrounding skin
Time Frame: Day 56
|
scale 0 to 10
|
Day 56
|
|
Clinical scoring target lesion comparing to surrounding skin
Time Frame: Day 84
|
scale 0 to 10
|
Day 84
|
|
Clinical scoring target lesion comparing to surrounding skin
Time Frame: Day 112
|
scale 0 to 10
|
Day 112
|
|
Clinical scoring target lesion comparing to surrounding skin
Time Frame: Day 140
|
scale 0 to 10
|
Day 140
|
|
Clinical scoring target lesion comparing to surrounding skin
Time Frame: Day 168
|
scale 0 to 10
|
Day 168
|
|
Subject global efficay rating
Time Frame: Day 28
|
rating
|
Day 28
|
|
Subject global efficay rating
Time Frame: Day 56
|
rating
|
Day 56
|
|
Subject global efficay rating
Time Frame: Day 84
|
rating
|
Day 84
|
|
Subject global efficay rating
Time Frame: Day 112
|
rating
|
Day 112
|
|
Subject global efficay rating
Time Frame: Day 140
|
rating
|
Day 140
|
|
Subject global efficay rating
Time Frame: Day 168
|
rating
|
Day 168
|
|
Investigator global efficay rating
Time Frame: Day 28
|
rating
|
Day 28
|
|
Investigator global efficay rating
Time Frame: Day 56
|
rating
|
Day 56
|
|
Investigator global efficay rating
Time Frame: Day 84
|
rating
|
Day 84
|
|
Investigator global efficay rating
Time Frame: Day 112
|
rating
|
Day 112
|
|
Investigator global efficay rating
Time Frame: Day 140
|
rating
|
Day 140
|
|
Investigator global efficay rating
Time Frame: Day 168
|
rating
|
Day 168
|
|
Cosmetic acceptability
Time Frame: Day 28
|
questionnaire
|
Day 28
|
|
Cosmetic acceptability
Time Frame: Day 56
|
questionnaire
|
Day 56
|
|
Cosmetic acceptability
Time Frame: Day 84
|
questionnaire
|
Day 84
|
|
Cosmetic acceptability
Time Frame: Day 112
|
questionnaire
|
Day 112
|
|
Cosmetic acceptability
Time Frame: Day 140
|
questionnaire
|
Day 140
|
|
Cosmetic acceptability
Time Frame: Day 168
|
questionnaire
|
Day 168
|
|
Evolution of quality of life
Time Frame: Day -28
|
MelasQoL
|
Day -28
|
|
Evolution of quality of life
Time Frame: baseline
|
MelasQoL
|
baseline
|
|
Evolution of quality of life
Time Frame: Day 28
|
MelasQoL
|
Day 28
|
|
Evolution of quality of life
Time Frame: Day 56
|
MelasQoL
|
Day 56
|
|
Evolution of quality of life
Time Frame: Day 84
|
MelasQoL
|
Day 84
|
|
Evolution of quality of life
Time Frame: Day 112
|
MelasQoL
|
Day 112
|
|
Evolution of quality of life
Time Frame: Day 140
|
MelasQoL
|
Day 140
|
|
Evolution of quality of life
Time Frame: Day 156
|
MelasQoL
|
Day 156
|
|
images
Time Frame: baseline
|
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
|
baseline
|
|
images
Time Frame: Day 28
|
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
|
Day 28
|
|
images
Time Frame: Day 56
|
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
|
Day 56
|
|
images
Time Frame: Day 84
|
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
|
Day 84
|
|
images
Time Frame: Day 112
|
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
|
Day 112
|
|
images
Time Frame: Day 140
|
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
|
Day 140
|
|
images
Time Frame: Day 168
|
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
|
Day 168
|
|
Skin quality
Time Frame: baseline
|
Chromameter, Individual Typology Angle (ITA)
|
baseline
|
|
Skin quality
Time Frame: Day 28
|
Chromameter, Individual Typology Angle (ITA)
|
Day 28
|
|
Skin quality
Time Frame: Day 56
|
Chromameter, Individual Typology Angle (ITA)
|
Day 56
|
|
Skin quality
Time Frame: Day 84
|
Chromameter, Individual Typology Angle (ITA)
|
Day 84
|
|
Skin quality
Time Frame: Day 112
|
Chromameter, Individual Typology Angle (ITA)
|
Day 112
|
|
Skin quality
Time Frame: Day 140
|
Chromameter, Individual Typology Angle (ITA)
|
Day 140
|
|
Skin quality
Time Frame: Day 168
|
Chromameter, Individual Typology Angle (ITA)
|
Day 168
|
|
transepidermal water loss
Time Frame: baseline
|
Tewameter
|
baseline
|
|
transepidermal water loss
Time Frame: Day 28
|
Tewameter
|
Day 28
|
|
transepidermal water loss
Time Frame: Day 56
|
Tewameter
|
Day 56
|
|
transepidermal water loss
Time Frame: Day 84
|
Tewameter
|
Day 84
|
|
transepidermal water loss
Time Frame: Day 112
|
Tewameter
|
Day 112
|
|
transepidermal water loss
Time Frame: Day 140
|
Tewameter
|
Day 140
|
|
transepidermal water loss
Time Frame: Day 168
|
Tewameter
|
Day 168
|
|
skin hydration
Time Frame: baseline
|
Corneometer
|
baseline
|
|
skin hydration
Time Frame: Day 28
|
Corneometer
|
Day 28
|
|
skin hydration
Time Frame: Day 56
|
Corneometer
|
Day 56
|
|
skin hydration
Time Frame: Day 84
|
Corneometer
|
Day 84
|
|
skin hydration
Time Frame: Day 112
|
Corneometer
|
Day 112
|
|
skin hydration
Time Frame: Day 140
|
Corneometer
|
Day 140
|
|
skin hydration
Time Frame: Day 168
|
Corneometer
|
Day 168
|
|
confocal
Time Frame: baseline
|
confocal measurements (15 subjects)
|
baseline
|
|
confocal
Time Frame: Day 84
|
confocal measurements (15 subjects)
|
Day 84
|
|
confocal
Time Frame: Day 168
|
confocal measurements (15 subjects)
|
Day 168
|
|
exposome questionnaire
Time Frame: baseline
|
questionnaire
|
baseline
|
|
Melasma status
Time Frame: baseline
|
questionnaire
|
baseline
|
|
adverse events
Time Frame: baseline
|
reporting
|
baseline
|
|
adverse events
Time Frame: Day 28
|
reporting
|
Day 28
|
|
adverse events
Time Frame: Day 56
|
reporting
|
Day 56
|
|
adverse events
Time Frame: Day 84
|
reporting
|
Day 84
|
|
adverse events
Time Frame: Day 112
|
reporting
|
Day 112
|
|
adverse events
Time Frame: Day 140
|
reporting
|
Day 140
|
|
adverse events
Time Frame: Day 168
|
reporting
|
Day 168
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Claire Deloche-Bensmain, PhD, La Roche Posayl Laboratoires Dermatologiques
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- VCY23-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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