Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
NCT ID: NCT06516224
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2024-07-15
2025-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Tolerability of Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins
NCT06320314
Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins
NCT06268496
Efficacy and Tolerability of Tested Formula After 3 Months of Treatment of Facial Hyperpigmentation of 3 Origins
NCT06253468
Efficacy and Tolerability of the Tested Formula After 3 Months of Treatment of Facial Hyperpigmentation of 3 Origins
NCT06234527
Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins
NCT06253455
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
• 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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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+
Liftactiv® 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.
Liftactiv® 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.
Sunscreen UVAage® Inter SPF 50+
twice daily (morning and beginning of the afternoon)
Mineral 89 cream
2 drops in the morning before sunscreen application for 6 months
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
Liftactiv® 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.
Liftactiv® 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.
Sunscreen UVAage® Inter SPF 50+
twice daily (morning and beginning of the afternoon)
Mineral 89 cream
2 drops in the morning before sunscreen application for 6 months
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
Liftactiv® 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.
Liftactiv® 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.
Sunscreen UVAage® Inter SPF 50+
twice daily (morning and beginning of the afternoon)
Mineral 89 cream
2 drops in the morning before sunscreen application for 6 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Liftactiv® 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.
Liftactiv® 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.
Sunscreen UVAage® Inter SPF 50+
twice daily (morning and beginning of the afternoon)
Mineral 89 cream
2 drops in the morning before sunscreen application for 6 months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cosmetique Active International
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claire Deloche-Bensmain, PhD
Role: STUDY_DIRECTOR
La Roche Posayl Laboratoires Dermatologiques
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CIDP
Rio de Janeiro, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Alessandro NASCIMENTO
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VCY23-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.