Pilonidal DiseasePhase 4NCT06640946
Pain Control for Laser Epilation in Pilonidal Disease
A Phase 4 study testing Topical lidocaine in people with Pilonidal Disease, run by David Mooney at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- Topical lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
-
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital at Waltham
Waltham, Massachusetts, 02453
About this study
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.
Read the 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.
- Conditions
- Pilonidal Disease
- Being tested
- Topical lidocaine, Sham cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical lidocaineDrug
Also called LMX
Topical lidocaine cream prior to laser follicle ablation
Sham creamDrug
Placebo cream without lidocaine will be placed and removed before laser.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sham cream placed and then removed prior to laser follicle ablation. Receives: Drug: Sham cream |
| Active agent | Active comparator | Topical lidocaine cream placed and then removed prior to laser follicle ablation. Receives: Drug: Topical lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain related to laser follicle ablation
Patient description on a Likert scale from 0 to 10 of the discomfort associated with the procedure.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024
- Primary completion1 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo versus agent crossover per patient
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Mooney
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Mooney, Boston Children's Hospital
- Investigators
- Ashley P Stoeckel, MD, Study chair, Boston Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640946
- Sponsor's protocol ID
- P00048869
- Status last verified
- Jun 2025
- First submitted
- 10 Oct 2024
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol details and anonymized patient data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control for Laser Epilation in Pilonidal Disease
- ClinicalTrials.gov ID
- NCT06640946
- Acronym / sponsor ID
- P00048869
- Conditions
- Pilonidal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- David MooneyUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo versus agent crossover per patient
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Sham creamSham cream placed and then removed prior to laser follicle ablation. |
| Active agent | Active comparator | Drug: Topical lidocaineTopical lidocaine cream placed and then removed prior to laser follicle ablation. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical lidocaineAlso: LMXTopical lidocaine cream prior to laser follicle ablation | Drug | Active agent |
| Sham creamPlacebo cream without lidocaine will be placed and removed before laser. | Drug | Placebo |
Primary outcome
Pain related to laser follicle ablation
Time frame: 5 minutes
Patient description on a Likert scale from 0 to 10 of the discomfort associated with the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Yes. Protocol details and anonymized patient data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley P Stoeckel, MD study chair
Boston Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical lidocaine in people with Pilonidal Disease, run by David Mooney at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain related to laser follicle ablation (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.