Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366503
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-10
Brief Title:
Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation
Sponsor:
Revision Skincare
Organization:
Revision Skincare
Study Overview
Official Title:
A Randomized Single-Center Double-Blinded Split-Face Controlled Study Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation
Status:
COMPLETED
Status Verified Date:
2024-04
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 single-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 fractional ablative CO2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage score of 4 to 9 out of the 10-point Modified Griffiths scale Furthermore this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures This is a cosmetic study with a FDA-regulated device
A total of 22 healthy female subjects completed the study
A total of 22 healthy female subjects completed the study
Detailed Description:
This randomized single-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 fractional ablative CO2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage score of 4 to 9 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 and pain over the course of the study Furthermore this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures
A 14-day washout period was required of all subjects prior to CO2 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 7 and 14 post-procedure Pain evaluations were completed by subjects using the 11-point Wong Baker Faces Pain Rating scale post-procedure post-procedurepost-product application and days 1 3 5 7 and 14 post-procedure
In addition efficacy evaluation using the Modified Griffiths scale was performed at screening pre-procedure and days 1 3 5 7 and 14 post-procedure Self-assessment questionnaires were completed by subjects post-procedurepost-product application and days 1 3 and 14 post-procedure Clinical photography was completed at all timepoints screening to day 14 post-procedure
A total of 22 subjects completed study participation
A 14-day washout period was required of all subjects prior to CO2 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 7 and 14 post-procedure Pain evaluations were completed by subjects using the 11-point Wong Baker Faces Pain Rating scale post-procedure post-procedurepost-product application and days 1 3 5 7 and 14 post-procedure
In addition efficacy evaluation using the Modified Griffiths scale was performed at screening pre-procedure and days 1 3 5 7 and 14 post-procedure Self-assessment questionnaires were completed by subjects post-procedurepost-product application and days 1 3 and 14 post-procedure Clinical photography was completed at all timepoints screening to day 14 post-procedure
A total of 22 subjects completed study participation
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?:
False
Is an FDA AA801 Violation?:
None