Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436261
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Hybrid-Fractional Laser for Facial Rejuvenation
Sponsor:
Revision Skincare
Organization:
Revision Skincare
Study Overview
Official Title:
A Randomized Multi-Center Double-Blinded Split-Face Controlled Study Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Hybrid-Factional Laser for Facial Rejuvenation
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized multi-center double-blinded split-face controlled clinical trial was conducted to investigate the tolerability safety and efficacy of a post-procedure cream when used immediately after hybrid-fractional laser treatment and for 7 days post-procedure with three times daily application in healthy female subjects aged 35-65 years with moderate to severe global face photodamage score of 4 to 7 out of the 10-point Modified Griffiths scale Furthermore this clinical trial compared the active post-procedure cream to a comparator moisturizer often paired with skin rejuvenation procedures This is a cosmetic study with an FDA-regulated device
A total of 16 healthy female subjects completed the study 8 subjects at both sites
A total of 16 healthy female subjects completed the study 8 subjects at both sites
Detailed Description:
This randomized multi-center double-blinded split-face controlled clinical trial was conducted to investigate the tolerability safety and efficacy of a post-procedure cream when used immediately after hybrid-fractional laser treatment and for 7 days post-procedure with three times daily application in healthy female subjects aged 35-65 years with moderate to severe global face photodamage score of 4 to 7 out of the 10-point modified Griffiths scale The ability of the post-procedure cream to soothe skin and improve patient downtime post-procedure was investigated by evaluating tolerability parameters erythema edema dryness burning itching stinging over the course of the study Furthermore this clinical trial compared the active post-procedure cream to a comparator moisturizer often paired with skin rejuvenation procedures
A 7-day washout period was required of all subjects prior to hybrid-fractional laser treatment Tolerability investigator erythema edema dryness subject burning itching stinging and safety were assessed through grading at screening pre-procedure post-procedure post-procedurepost-product application and days 1 3 5 and 7 post-procedure
In addition efficacy evaluation using the Modified Griffiths scale was performed at screening pre-procedure and day 7 post-procedure Self-assessment questionnaires were completed by subjects post-procedurepost-product application and days 1 5 and 7 post-procedure Clinical photography was completed at screening pre-procedure post-procedurepost-product application and days 1 3 5 and 7 post-procedure
A total of 16 healthy female subjects completed the study 8 subjects at both sites
A 7-day washout period was required of all subjects prior to hybrid-fractional laser treatment Tolerability investigator erythema edema dryness subject burning itching stinging and safety were assessed through grading at screening pre-procedure post-procedure post-procedurepost-product application and days 1 3 5 and 7 post-procedure
In addition efficacy evaluation using the Modified Griffiths scale was performed at screening pre-procedure and day 7 post-procedure Self-assessment questionnaires were completed by subjects post-procedurepost-product application and days 1 5 and 7 post-procedure Clinical photography was completed at screening pre-procedure post-procedurepost-product application and days 1 3 5 and 7 post-procedure
A total of 16 healthy female subjects completed the study 8 subjects at both sites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None