Melasma
Conditions
Keywords
melasma, hyperpigmentation
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
Interventions
OTHERLiftactiv® 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.
OTHERLiftactiv® 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.
OTHERSunscreen UVAage® Inter SPF 50+
twice daily (morning and beginning of the afternoon)
OTHERMineral 89 cream
2 drops in the morning before sunscreen application for 6 months
Sponsors
Cosmetique Active International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Subjects will be randomized in three groups and will be treated differently taking into account only the original Melasma Area Severity Index (MASI) score at baseline: • An adaptive randomization scheme (minimization method) will be used to determine the treatment group (among the 3 available) to which eligible subjects will be enrolled in. This strategy will ensure a balance between treatment groups for one important prognostic factor, identified as 'baseline MASI'. When a new subject is eligible for randomization, the algorithm verifies the average MASI of the subjects in each group. The new subject will be allocated to a group in such a way that the imbalance is minimized among the groups.
Intervention model description
single-center, randomised, 3 group study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| antipigmenting assessment | Day 84 | Melasma Area Severity Index (MASI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment (IGA) assessment | Day -28 | IGA score |
| Clinical assessment (fine lines, skin tone, radiance, texture and elasticity) | Day -28 | scores 0 to 5 |
| Clinical scoring hyperpigmentation | baseline | scale 0 to 10 |
| Clinical scoring target lesion comparing to surrounding skin | baseline | scale 0 to 10 |
| Subject global efficay rating | Day 28 | rating |
| Investigator global efficay rating | Day 28 | rating |
| Cosmetic acceptability | Day 28 | questionnaire |
| Evolution of quality of life | Day -28 | MelasQoL |
| antipigmenting assessment | Day-28 | Melasma Area Severity Index(MASI) |
| transepidermal water loss | baseline | Tewameter |
| Skin quality | baseline | Chromameter, Individual Typology Angle (ITA) |
| skin hydration | baseline | Corneometer |
| exposome questionnaire | baseline | questionnaire |
| confocal | baseline | confocal measurements (15 subjects) |
| Melasma status | baseline | questionnaire |
| adverse events | baseline | reporting |
| images | baseline | Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights. |
Countries
Brazil
Contacts
Primary ContactClaire Deloche-Bensmain, PhD
Backup ContactMarianna Feiges
Outcome results
None listed