Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516224
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-07
Brief Title:
Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Efficacy of the Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 KTVitacid 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 Physicians 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
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 KTVitacid 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 Physicians 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None