MelasmaNCT06516224
Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
A study testing Liftactiv® B3 Serum, Liftactiv® B3 retinol night cream and Sunscreen UVAage® Inter SPF 50+ in people with Melasma, run by Cosmetique Active International at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- Liftactiv® B3 Serum, Liftactiv® B3 retinol night cream and Sunscreen UVAage® Inter SPF 50+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jul 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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);
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Marianna Feiges contact
About this study
Official title: 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.
Read the 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:
- 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
- Conditions
- Melasma
- Being tested
- Liftactiv® B3 Serum, Liftactiv® B3 retinol night cream, Sunscreen UVAage® Inter SPF 50+, Mineral 89 cream
- Keywords
- melasma, hyperpigmentation
- Medical subject headings
- Melanosis, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liftactiv® B3 SerumOther
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.
Liftactiv® B3 retinol night creamOther
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.
Sunscreen UVAage® Inter SPF 50+Other
twice daily (morning and beginning of the afternoon)
Mineral 89 creamOther
2 drops in the morning before sunscreen application for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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+ Receives: Other: Liftactiv® B3 Serum; Other: Liftactiv® B3 retinol night cream; Other: Sunscreen UVAage® Inter SPF 50+; Other: Mineral 89 cream |
| Group 2 | Active comparator | 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 Receives: Other: Liftactiv® B3 Serum; Other: Liftactiv® B3 retinol night cream; Other: Sunscreen UVAage® Inter SPF 50+; Other: Mineral 89 cream |
| Group 3 | Active comparator | 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 Receives: Other: Liftactiv® B3 Serum; Other: Liftactiv® B3 retinol night cream; Other: Sunscreen UVAage® Inter SPF 50+; Other: Mineral 89 cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
antipigmenting assessment
Melasma Area Severity Index (MASI)
Measured: Day 84
antipigmenting assessment
modified Melasma Area Severity Index (mMASI)
Measured: Day 84
antipigmenting assessment
Melasma Area Severity Index(MASI)
Measured: Day 168
antipigmenting assessment
modified Melasma Area Severity Index (mMASI)
Measured: Day 168
Secondary outcomes (105)
antipigmenting assessment
Melasma Area Severity Index(MASI)
Measured: Day-28
antipigmenting assessment
modified Melasma Area Severity Index (mMASI)
Measured: Day-28
antipigmenting assessment
Melasma Area Severity Index(MASI)
Measured: baseline
antipigmenting assessment
modified Melasma Area Severity Index (mMASI)
Measured: baseline
antipigmenting assessment
Melasma Area Severity Index(MASI)
Measured: Day 28
antipigmenting assessment
modified Melasma Area Severity Index (mMASI)
Measured: Day 28
antipigmenting assessment
Melasma Area Severity Index(MASI)
Measured: Day 56
antipigmenting assessment
modified Melasma Area Severity Index (mMASI)
Measured: Day 56
antipigmenting assessment
Melasma Area Severity Index(MASI)
Measured: Day 112
antipigmenting assessment
modified Melasma Area Severity Index (mMASI)
Measured: Day 112
antipigmenting assessment
Melasma Area Severity Index(MASI)
Measured: Day 140
antipigmenting assessment
modified Melasma Area Severity Index (mMASI)
Measured: Day 140
Investigator Global Assessment (IGA) assessment
IGA score
Measured: Day -28
Investigator Global Assessment (IGA) assessment
IGA score
Measured: baseline
Investigator Global Assessment (IGA) assessment
IGA score
Measured: Day 28
Investigator Global Assessment (IGA) assessment
IGA score
Measured: Day 56
Investigator Global Assessment (IGA) assessment
IGA score
Measured: Day 84
Investigator Global Assessment (IGA) assessment
IGA score
Measured: Day 112
Investigator Global Assessment (IGA) assessment
IGA score
Measured: Day 140
Investigator Global Assessment (IGA) assessment
IGA score
Measured: Day 168
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
scores 0 to 5
Measured: Day -28
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
scores 0 to 5
Measured: baseline
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
scores 0 to 5
Measured: Day 28
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
scores 0 to 5
Measured: Day 84
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
scores 0 to 5
Measured: Day 168
Clinical scoring hyperpigmentation
scale 0 to 10
Measured: baseline
Clinical scoring hyperpigmentation
scale 0 to 10
Measured: Day 28
Clinical scoring hyperpigmentation
scale 0 to 10
Measured: Day 56
Clinical scoring hyperpigmentation
scale 0 to 10
Measured: Day 84
Clinical scoring hyperpigmentation
scale 0 to 10
Measured: Day 112
Clinical scoring hyperpigmentation
scale 0 to 10
Measured: Day 140
Clinical scoring hyperpigmentation
scale 0 to 10
Measured: Day 168
Clinical scoring target lesion comparing to surrounding skin
scale 0 to 10
Measured: baseline
Clinical scoring target lesion comparing to surrounding skin
scale 0 to 10
Measured: Day 28
Clinical scoring target lesion comparing to surrounding skin
scale 0 to 10
Measured: Day 56
Clinical scoring target lesion comparing to surrounding skin
scale 0 to 10
Measured: Day 84
Clinical scoring target lesion comparing to surrounding skin
scale 0 to 10
Measured: Day 112
Clinical scoring target lesion comparing to surrounding skin
scale 0 to 10
Measured: Day 140
Clinical scoring target lesion comparing to surrounding skin
scale 0 to 10
Measured: Day 168
Subject global efficay rating
rating
Measured: Day 28
Subject global efficay rating
rating
Measured: Day 56
Subject global efficay rating
rating
Measured: Day 84
Subject global efficay rating
rating
Measured: Day 112
Subject global efficay rating
rating
Measured: Day 140
Subject global efficay rating
rating
Measured: Day 168
Investigator global efficay rating
rating
Measured: Day 28
Investigator global efficay rating
rating
Measured: Day 56
Investigator global efficay rating
rating
Measured: Day 84
Investigator global efficay rating
rating
Measured: Day 112
Investigator global efficay rating
rating
Measured: Day 140
Investigator global efficay rating
rating
Measured: Day 168
Cosmetic acceptability
questionnaire
Measured: Day 28
Cosmetic acceptability
questionnaire
Measured: Day 56
Cosmetic acceptability
questionnaire
Measured: Day 84
Cosmetic acceptability
questionnaire
Measured: Day 112
Cosmetic acceptability
questionnaire
Measured: Day 140
Cosmetic acceptability
questionnaire
Measured: Day 168
Evolution of quality of life
MelasQoL
Measured: Day -28
Evolution of quality of life
MelasQoL
Measured: baseline
Evolution of quality of life
MelasQoL
Measured: Day 28
Evolution of quality of life
MelasQoL
Measured: Day 56
Evolution of quality of life
MelasQoL
Measured: Day 84
Evolution of quality of life
MelasQoL
Measured: Day 112
Evolution of quality of life
MelasQoL
Measured: Day 140
Evolution of quality of life
MelasQoL
Measured: Day 156
images
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
Measured: baseline
images
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
Measured: Day 28
images
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
Measured: Day 56
images
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
Measured: Day 84
images
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
Measured: Day 112
images
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
Measured: Day 140
images
Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
Measured: Day 168
Skin quality
Chromameter, Individual Typology Angle (ITA)
Measured: baseline
Skin quality
Chromameter, Individual Typology Angle (ITA)
Measured: Day 28
Skin quality
Chromameter, Individual Typology Angle (ITA)
Measured: Day 56
Skin quality
Chromameter, Individual Typology Angle (ITA)
Measured: Day 84
Skin quality
Chromameter, Individual Typology Angle (ITA)
Measured: Day 112
Skin quality
Chromameter, Individual Typology Angle (ITA)
Measured: Day 140
Skin quality
Chromameter, Individual Typology Angle (ITA)
Measured: Day 168
transepidermal water loss
Tewameter
Measured: baseline
transepidermal water loss
Tewameter
Measured: Day 28
transepidermal water loss
Tewameter
Measured: Day 56
transepidermal water loss
Tewameter
Measured: Day 84
transepidermal water loss
Tewameter
Measured: Day 112
transepidermal water loss
Tewameter
Measured: Day 140
transepidermal water loss
Tewameter
Measured: Day 168
skin hydration
Corneometer
Measured: baseline
skin hydration
Corneometer
Measured: Day 28
skin hydration
Corneometer
Measured: Day 56
skin hydration
Corneometer
Measured: Day 84
skin hydration
Corneometer
Measured: Day 112
skin hydration
Corneometer
Measured: Day 140
skin hydration
Corneometer
Measured: Day 168
confocal
confocal measurements (15 subjects)
Measured: baseline
confocal
confocal measurements (15 subjects)
Measured: Day 84
confocal
confocal measurements (15 subjects)
Measured: Day 168
exposome questionnaire
questionnaire
Measured: baseline
Melasma status
questionnaire
Measured: baseline
adverse events
reporting
Measured: baseline
adverse events
reporting
Measured: Day 28
adverse events
reporting
Measured: Day 56
adverse events
reporting
Measured: Day 84
adverse events
reporting
Measured: Day 112
adverse events
reporting
Measured: Day 140
adverse events
reporting
Measured: Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, randomised, 3 group study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claire Deloche-Bensmain, PhD, Study director, La Roche Posayl Laboratoires Dermatologiques
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516224
- Sponsor's protocol ID
- VCY23-001
- Status last verified
- Jul 2024
- First submitted
- 7 May 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the protocol will be shared by the sponsor upon reasonable request for one year after the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
- ClinicalTrials.gov ID
- NCT06516224
- Acronym / sponsor ID
- VCY23-001
- Conditions
- Melasma
- Keywords
- melasma, hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- single-center, randomised, 3 group study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Liftactiv® B3 Serum, Other: Liftactiv® B3 retinol night cream, Other: Sunscreen UVAage® Inter SPF 50+, Other: Mineral 89 creamdermocosmetic 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+ |
| Group 2 | Active comparator | Other: Liftactiv® B3 Serum, Other: Liftactiv® B3 retinol night cream, Other: Sunscreen UVAage® Inter SPF 50+, Other: Mineral 89 creamhydroquinone 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 |
| Group 3 | Active comparator | Other: Liftactiv® B3 Serum, Other: Liftactiv® B3 retinol night cream, Other: Sunscreen UVAage® Inter SPF 50+, Other: Mineral 89 creamCombination 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liftactiv® B3 SerumIn 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 | Group 1, Group 2, Group 3 |
| Liftactiv® B3 retinol night creamIn 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 | Group 1, Group 2, Group 3 |
| Sunscreen UVAage® Inter SPF 50+twice daily (morning and beginning of the afternoon) | Other | Group 1, Group 2, Group 3 |
| Mineral 89 cream2 drops in the morning before sunscreen application for 6 months | Other | Group 1, Group 2, Group 3 |
Primary outcome
antipigmenting assessment
Time frame: Day 84
Melasma Area Severity Index (MASI)
antipigmenting assessment
Time frame: Day 84
modified Melasma Area Severity Index (mMASI)
antipigmenting assessment
Time frame: Day 168
Melasma Area Severity Index(MASI)
antipigmenting assessment
Time frame: Day 168
modified Melasma Area Severity Index (mMASI)
105 secondary outcomes
antipigmenting assessment
Time frame: Day-28
antipigmenting assessment
Time frame: Day-28
antipigmenting assessment
Time frame: baseline
antipigmenting assessment
Time frame: baseline
antipigmenting assessment
Time frame: Day 28
antipigmenting assessment
Time frame: Day 28
antipigmenting assessment
Time frame: Day 56
antipigmenting assessment
Time frame: Day 56
antipigmenting assessment
Time frame: Day 112
antipigmenting assessment
Time frame: Day 112
antipigmenting assessment
Time frame: Day 140
antipigmenting assessment
Time frame: Day 140
Investigator Global Assessment (IGA) assessment
Time frame: Day -28
Investigator Global Assessment (IGA) assessment
Time frame: baseline
Investigator Global Assessment (IGA) assessment
Time frame: Day 28
Investigator Global Assessment (IGA) assessment
Time frame: Day 56
Investigator Global Assessment (IGA) assessment
Time frame: Day 84
Investigator Global Assessment (IGA) assessment
Time frame: Day 112
Investigator Global Assessment (IGA) assessment
Time frame: Day 140
Investigator Global Assessment (IGA) assessment
Time frame: Day 168
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
Time frame: Day -28
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
Time frame: baseline
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
Time frame: Day 28
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
Time frame: Day 84
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
Time frame: Day 168
Clinical scoring hyperpigmentation
Time frame: baseline
Clinical scoring hyperpigmentation
Time frame: Day 28
Clinical scoring hyperpigmentation
Time frame: Day 56
Clinical scoring hyperpigmentation
Time frame: Day 84
Clinical scoring hyperpigmentation
Time frame: Day 112
Clinical scoring hyperpigmentation
Time frame: Day 140
Clinical scoring hyperpigmentation
Time frame: Day 168
Clinical scoring target lesion comparing to surrounding skin
Time frame: baseline
Clinical scoring target lesion comparing to surrounding skin
Time frame: Day 28
Clinical scoring target lesion comparing to surrounding skin
Time frame: Day 56
Clinical scoring target lesion comparing to surrounding skin
Time frame: Day 84
Clinical scoring target lesion comparing to surrounding skin
Time frame: Day 112
Clinical scoring target lesion comparing to surrounding skin
Time frame: Day 140
Clinical scoring target lesion comparing to surrounding skin
Time frame: Day 168
Subject global efficay rating
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Yes. the protocol will be shared by the sponsor upon reasonable request for one year after the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianna Feiges contact
Claire Deloche-Bensmain, PhD study director
La Roche Posayl Laboratoires Dermatologiques
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liftactiv® B3 Serum, Liftactiv® B3 retinol night cream and Sunscreen UVAage® Inter SPF 50+ in people with Melasma, run by Cosmetique Active International at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Deloche-Bensmain, PhD (+33 7 76 11 27 98, claire.deloche-bensmaine@loreal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antipigmenting assessment (time frame: Day 84). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.