Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
- Conditions
- Melasma
- Interventions
- Other: Liftactiv® B3 SerumOther: Liftactiv® B3 retinol night creamOther: Sunscreen UVAage® Inter SPF 50+Other: Mineral 89 cream
- Registration Number
- NCT06516224
- Lead Sponsor
- Cosmetique Active International
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Liftactiv® B3 retinol night cream 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+ Group 2 Mineral 89 cream 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 Group 3 Liftactiv® B3 Serum 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 Group 1 Sunscreen UVAage® Inter SPF 50+ 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+ Group 1 Mineral 89 cream 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+ Group 2 Liftactiv® B3 retinol night cream 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 Group 2 Sunscreen UVAage® Inter SPF 50+ 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 Group 3 Sunscreen UVAage® Inter SPF 50+ 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 Group 1 Liftactiv® B3 Serum 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+ Group 2 Liftactiv® B3 Serum 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 Group 3 Liftactiv® B3 retinol night cream 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 Group 3 Mineral 89 cream 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
- Primary Outcome Measures
Name Time Method antipigmenting assessment Day 168 modified Melasma Area Severity Index (mMASI)
- Secondary Outcome Measures
Name Time Method antipigmenting assessment Day 140 modified Melasma Area Severity Index (mMASI)
Investigator Global Assessment (IGA) assessment Day 168 IGA score
Clinical assessment (fine lines, skin tone, radiance, texture and elasticity) Day 168 scores 0 to 5
Clinical scoring hyperpigmentation Day 168 scale 0 to 10
Clinical scoring target lesion comparing to surrounding skin Day 168 scale 0 to 10
images Day 168 Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights.
Skin quality Day 168 Chromameter, Individual Typology Angle (ITA)
confocal Day 168 confocal measurements (15 subjects)
Melasma status baseline questionnaire
adverse events Day 168 reporting
skin hydration Day 168 Corneometer
Subject global efficay rating Day 168 rating
Investigator global efficay rating Day 168 rating
Cosmetic acceptability Day 168 questionnaire
Evolution of quality of life Day 156 MelasQoL
transepidermal water loss Day 168 Tewameter
exposome questionnaire baseline questionnaire
Trial Locations
- Locations (1)
CIDP
🇧🇷Rio de Janeiro, Brazil