Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma

Not Applicable

Not yet recruiting

• Conditions: Melasma

• 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

Study Timeline

• Study First Submitted: 2024-05-07
• Status Verified: 2024-07
• Study Start: 2024-07-15
• Study First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
antipigmenting assessment	Day 168	modified Melasma Area Severity Index (mMASI)

Secondary Outcome Measures

Name	Time	Method
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
skin hydration	Day 168	Corneometer
exposome questionnaire	baseline	questionnaire
confocal	Day 168	confocal measurements (15 subjects)
Melasma status	baseline	questionnaire
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)
adverse events	Day 168	reporting

Trial Locations

Locations (1)

CIDP; 🇧🇷 Rio de Janeiro, Brazil