Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644157
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Treatment and Prevention of Melasma Relapses by Using 1064nm 650 Microsecond Laser
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatment and Prevention of Melasma Relapses by Using 1064nm 650 Microsecond Laser a Prospective Randomized Intra-individual Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Melasma650
Brief Summary:
Melasma is a frequently acquired hyperpigmentary disorder affecting up to 30 of child-bearing women in some populations Melasma is still often called chloasma or the pregnancy mask and is considered as the main consequence of female hormone stimulation on a predisposed genetic background but only 20 of pregnant women are affected The investigator hypothesize that the Aerolase laser treatment could not only enhance the efficacy of the topical depigmenting agents but also by reducing the vascular component decrease the intensity of the relapses
All patients applied to the entire face the cosmetic depigmenting agent Mela B3 La Roche Posay cream twice daily for 3 months One session of laser on one side of the face randomly assigned for each patient for the duration of the study will be performed every other week for 12 weeks for a total of 6 sessions All the patients will apply the entire face a sunscreen of sun protection factor 50 with high UVA protection UV Mune 400 La Roche Posay during the entire study duration
All patients applied to the entire face the cosmetic depigmenting agent Mela B3 La Roche Posay cream twice daily for 3 months One session of laser on one side of the face randomly assigned for each patient for the duration of the study will be performed every other week for 12 weeks for a total of 6 sessions All the patients will apply the entire face a sunscreen of sun protection factor 50 with high UVA protection UV Mune 400 La Roche Posay during the entire study duration
Detailed Description:
None
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