A Phase 4 interventional study of Topical lidocaine and Sham cream in Pilonidal Disease, sponsored by David Mooney. Completed at 1 site in United States. Open to participants aged 16 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by David Mooney · Phase 4, Interventional, and Treatment
It's 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.
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.
David Mooney is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: undergoing laser follicle ablation for pilonidal disease and expected to need at least 2 more treatments -
Exclusion Criteria: Unwilling to consent, not expected to need at least 2 more laser follicle ablations, not a candidate for laser
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Sham cream placed and then removed prior to laser follicle ablation.
Drug: Sham cream
Topical lidocaine cream placed and then removed prior to laser follicle ablation.
Drug: Topical lidocaine
Topical lidocaine cream prior to laser follicle ablation
Also known as: LMX
Placebo cream without lidocaine will be placed and removed before laser.
Pain related to laser follicle ablation
Patient description on a Likert scale from 0 to 10 of the discomfort associated with the procedure.
Time frame: 5 minutes
Plan to share: Yes — Protocol details and anonymized patient data will be shared
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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David Mooney