Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640946
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Pain Control for Laser Epilation in Pilonidal Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pain Control for Laser Epilation in Pilonidal Disease
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:
None
Brief Summary:
Its unclear if the application of topical lidocaine prior to laser follicle ablation is effective in reducing discomfort from the procedure This study will use a doubly blinded case-control model to evaluate pain scores after the procedure comparing topical lidocaine to placebo
Detailed Description:
Patients presenting to a dedicated Pilonidal Care Clinic who have at least 2 future laser follicle ablations planned will be queried to determine their interest in participating in the study Patients will be randomized to topical lidocaine or placebo which will be applied for 30 minutes prior to the laser procedure before which it will be removed Laser technicians will be unaware of which cream the patient received and will record a post-procedure Likert pain score from 0 to 10
Patients will return in 6 to 8 weeks at which time they will crossover to the other group Patients who received lidocaine cream will receive placebo and patients who received placebo will receive lidocaine cream Cream removal and laser follicle ablation with post-procedure pain score recording will be conducted as during the first visit
Twenty patients will be recruited and each patient will act as their own control
Patients will return in 6 to 8 weeks at which time they will crossover to the other group Patients who received lidocaine cream will receive placebo and patients who received placebo will receive lidocaine cream Cream removal and laser follicle ablation with post-procedure pain score recording will be conducted as during the first visit
Twenty patients will be recruited and each patient will act as their own control
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