Clinical trial NCT06516224: Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
Official title: Evaluation of the Efficacy of the Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Melasma
Keywords: melasma
hyperpigmentation
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, randomised, 3 group study
Primary purpose: TREATMENT

Brief 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 for 3 months in adult women with melasma on the face.

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

Eligibility criteria: 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.

Primary outcomes:
measure: antipigmenting assessment
timeFrame: Day 84
measure: antipigmenting assessment
timeFrame: Day 84
measure: antipigmenting assessment
timeFrame: Day 168
measure: antipigmenting assessment
timeFrame: Day 168
Secondary outcomes:
measure: antipigmenting assessment
timeFrame: Day-28
measure: antipigmenting assessment
timeFrame: Day-28
measure: antipigmenting assessment
timeFrame: baseline
measure: antipigmenting assessment
timeFrame: baseline
measure: antipigmenting assessment
timeFrame: Day 28
measure: antipigmenting assessment
timeFrame: Day 28
measure: antipigmenting assessment
timeFrame: Day 56
measure: antipigmenting assessment
timeFrame: Day 56
measure: antipigmenting assessment
timeFrame: Day 112
measure: antipigmenting assessment
timeFrame: Day 112
measure: antipigmenting assessment
timeFrame: Day 140
measure: antipigmenting assessment
timeFrame: Day 140
measure: Investigator Global Assessment (IGA) assessment
timeFrame: Day -28
measure: Investigator Global Assessment (IGA) assessment
timeFrame: baseline
measure: Investigator Global Assessment (IGA) assessment
timeFrame: Day 28
measure: Investigator Global Assessment (IGA) assessment
timeFrame: Day 56
measure: Investigator Global Assessment (IGA) assessment
timeFrame: Day 84
measure: Investigator Global Assessment (IGA) assessment
timeFrame: Day 112
measure: Investigator Global Assessment (IGA) assessment
timeFrame: Day 140
measure: Investigator Global Assessment (IGA) assessment
timeFrame: Day 168
measure: Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
timeFrame: Day -28
measure: Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
timeFrame: baseline
measure: Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
timeFrame: Day 28
measure: Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
timeFrame: Day 84
measure: Clinical assessment (fine lines, skin tone, radiance, texture and elasticity)
timeFrame: Day 168
measure: Clinical scoring hyperpigmentation
timeFrame: baseline
measure: Clinical scoring hyperpigmentation
timeFrame: Day 28
measure: Clinical scoring hyperpigmentation
timeFrame: Day 56
measure: Clinical scoring hyperpigmentation
timeFrame: Day 84
measure: Clinical scoring hyperpigmentation
timeFrame: Day 112
measure: Clinical scoring hyperpigmentation
timeFrame: Day 140
measure: Clinical scoring hyperpigmentation
timeFrame: Day 168
measure: Clinical scoring target lesion comparing to surrounding skin
timeFrame: baseline
measure: Clinical scoring target lesion comparing to surrounding skin
timeFrame: Day 28
measure: Clinical scoring target lesion comparing to surrounding skin
timeFrame: Day 56
measure: Clinical scoring target lesion comparing to surrounding skin
timeFrame: Day 84
measure: Clinical scoring target lesion comparing to surrounding skin
timeFrame: Day 112
measure: Clinical scoring target lesion comparing to surrounding skin
timeFrame: Day 140
measure: Clinical scoring target lesion comparing to surrounding skin
timeFrame: Day 168
measure: Subject global efficay rating
timeFrame: Day 28
measure: Subject global efficay rating
timeFrame: Day 56
measure: Subject global efficay rating
timeFrame: Day 84
measure: Subject global efficay rating
timeFrame: Day 112
measure: Subject global efficay rating
timeFrame: Day 140
measure: Subject global efficay rating
timeFrame: Day 168
measure: Investigator global efficay rating
timeFrame: Day 28
measure: Investigator global efficay rating
timeFrame: Day 56
measure: Investigator global efficay rating
timeFrame: Day 84
measure: Investigator global efficay rating
timeFrame: Day 112
measure: Investigator global efficay rating
timeFrame: Day 140
measure: Investigator global efficay rating
timeFrame: Day 168
measure: Cosmetic acceptability
timeFrame: Day 28
measure: Cosmetic acceptability
timeFrame: Day 56
measure: Cosmetic acceptability
timeFrame: Day 84
measure: Cosmetic acceptability
timeFrame: Day 112
measure: Cosmetic acceptability
timeFrame: Day 140
measure: Cosmetic acceptability
timeFrame: Day 168
measure: Evolution of quality of life
timeFrame: Day -28
measure: Evolution of quality of life
timeFrame: baseline
measure: Evolution of quality of life
timeFrame: Day 28
measure: Evolution of quality of life
timeFrame: Day 56
measure: Evolution of quality of life
timeFrame: Day 84
measure: Evolution of quality of life
timeFrame: Day 112
measure: Evolution of quality of life
timeFrame: Day 140
measure: Evolution of quality of life
timeFrame: Day 156
measure: images
timeFrame: baseline
measure: images
timeFrame: Day 28
measure: images
timeFrame: Day 56
measure: images
timeFrame: Day 84
measure: images
timeFrame: Day 112
measure: images
timeFrame: Day 140
measure: images
timeFrame: Day 168
measure: Skin quality
timeFrame: baseline
measure: Skin quality
timeFrame: Day 28
measure: Skin quality
timeFrame: Day 56
measure: Skin quality
timeFrame: Day 84
measure: Skin quality
timeFrame: Day 112
measure: Skin quality
timeFrame: Day 140
measure: Skin quality
timeFrame: Day 168
measure: transepidermal water loss
timeFrame: baseline
measure: transepidermal water loss
timeFrame: Day 28
measure: transepidermal water loss
timeFrame: Day 56
measure: transepidermal water loss
timeFrame: Day 84
measure: transepidermal water loss
timeFrame: Day 112
measure: transepidermal water loss
timeFrame: Day 140
measure: transepidermal water loss
timeFrame: Day 168
measure: skin hydration
timeFrame: baseline
measure: skin hydration
timeFrame: Day 28
measure: skin hydration
timeFrame: Day 56
measure: skin hydration
timeFrame: Day 84
measure: skin hydration
timeFrame: Day 112
measure: skin hydration
timeFrame: Day 140
measure: skin hydration
timeFrame: Day 168
measure: confocal
timeFrame: baseline
measure: confocal
timeFrame: Day 84
measure: confocal
timeFrame: Day 168
measure: exposome questionnaire
timeFrame: baseline
measure: Melasma status
timeFrame: baseline
measure: adverse events
timeFrame: baseline
measure: adverse events
timeFrame: Day 28
measure: adverse events
timeFrame: Day 56
measure: adverse events
timeFrame: Day 84
measure: adverse events
timeFrame: Day 112
measure: adverse events
timeFrame: Day 140
measure: adverse events
timeFrame: Day 168
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: CIDP
Study officials:
affiliation: La Roche Posayl Laboratoires Dermatologiques
name: Claire Deloche-Bensmain, PhD
role: STUDY_DIRECTOR
References: