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

NCT06516224 | Not Yet Recruiting

• 1 other identifier: VCY23-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Keywords

melasma; hyperpigmentation

Outcome Measures

Primary Outcomes (4)

• antipigmenting assessment

  Melasma Area Severity Index (MASI)

  Day 84

• antipigmenting assessment

  modified Melasma Area Severity Index (mMASI)

  Day 84

• antipigmenting assessment

  Melasma Area Severity Index(MASI)

  Day 168

• antipigmenting assessment

  modified Melasma Area Severity Index (mMASI)

  Day 168

Secondary Outcomes (105)

• antipigmenting assessment

  Day-28

• antipigmenting assessment

  Day-28

• antipigmenting assessment

  baseline

• antipigmenting assessment

  baseline

• antipigmenting assessment

  Day 28

Study Arms (3)

Group 1

EXPERIMENTAL

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+

Other: Liftactiv® B3 Serum; Other: Liftactiv® B3 retinol night cream; Other: Sunscreen UVAage® Inter SPF 50+; Other: Mineral 89 cream

Group 2

ACTIVE COMPARATOR

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

Other: Liftactiv® B3 Serum; Other: Liftactiv® B3 retinol night cream; Other: Sunscreen UVAage® Inter SPF 50+; Other: Mineral 89 cream

Group 3

ACTIVE COMPARATOR

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

Other: Liftactiv® B3 Serum; Other: Liftactiv® B3 retinol night cream; Other: Sunscreen UVAage® Inter SPF 50+; Other: Mineral 89 cream

Interventions

Liftactiv® B3 Serum OTHER

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.

Group 1; Group 2; Group 3

Liftactiv® B3 retinol night cream OTHER

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.

Group 1; Group 2; Group 3

Sunscreen UVAage® Inter SPF 50+ OTHER

twice daily (morning and beginning of the afternoon)

Group 1; Group 2; Group 3

Mineral 89 cream OTHER

2 drops in the morning before sunscreen application for 6 months

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Phototype II-V
• % 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

You may not qualify if:

• Subjects under topical or systemic retinoids;
• 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.

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

CIDP

Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Melanosis; Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Claire Deloche-Bensmain, PhD

  La Roche Posayl Laboratoires Dermatologiques

  STUDY DIRECTOR

Central Study Contacts

Claire Deloche-Bensmain, PhD

CONTACT

+33 7 76 11 27 98; claire.deloche-bensmaine@loreal.com

Marianna Feiges

CONTACT

mariana.feiges@loreal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-center, randomised, 3 group study

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: July 23, 2024
• Study Start: July 15, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one after finishing study
• Access Criteria: upon request to the sponsor

Locations

BR (1)