Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542341
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Study to Evaluate the Efficacy of the décoLITE LED Device in Treating the Signs of Skin Aging of the décolletage Area
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study to Evaluate the Efficacy of the décoLITE LED Device in Treating the Signs of Skin Aging of the décolletage Area
Status:
COMPLETED
Status Verified Date:
2024-08
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:
To assess the efficacy of the décoLITE LED system in reducing the signs of skin aging of the décolletage area one week after a six-week treatment course
Detailed Description:
This was an open-label single-center trial Subjects carried out 5 treatments on separate days each week for 6 weeks The plan for the study was to recruit 25 subjects to consider any dropouts to arrive at a final study total of 20
Treatments were of 10 minutes duration using a combination of red 630nm and near infrared 830nm emitted from light emitting diodes The device emitted 30mWcm2 of light delivering a dose of 18Jcm2 per treatment
Subjects were assessed at baseline at 5 weeks and at 7 weeks one week after the last treatment
Assessments included separate evaluations of lines and pigment of the décolletage using the validated scale developed by Landau et al by the principal investigator and a third party blinded physician standardized photography and recording of safety incidents Subjective responses were based on treatment efficacy and ease of use of the device
Treatments were of 10 minutes duration using a combination of red 630nm and near infrared 830nm emitted from light emitting diodes The device emitted 30mWcm2 of light delivering a dose of 18Jcm2 per treatment
Subjects were assessed at baseline at 5 weeks and at 7 weeks one week after the last treatment
Assessments included separate evaluations of lines and pigment of the décolletage using the validated scale developed by Landau et al by the principal investigator and a third party blinded physician standardized photography and recording of safety incidents Subjective responses were based on treatment efficacy and ease of use of the device
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