NCT02778152

Brief Summary

Pilot study to assess tolerability and safety of laser hair depilation in adolescents and young adults with pilonidal disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 26, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

May 17, 2016

Results QC Date

October 28, 2018

Last Update Submit

March 22, 2019

Conditions

Pilonidal Disease

Outcome Measures

Primary Outcomes (1)

  • Tolerability of Laser Treatment

    Median of pain scores immediately post-laser treatment after each of the 5 treatments. Pain was assessed on a scale of 1 to 10, 10 being the greatest amount of pain.

    five months

Secondary Outcomes (1)

  • Number of Participants Experiencing Second Degree Burns Post-Treatment

    five months

Study Arms (1)

Laser depilation

EXPERIMENTAL

Laser depilation to the natal cleft (pilonidal region) monthly for 5 treatments with either an 810nm of Nd:YAG laser dependent on Fitzpatrick skin type and tolerability.

Device: Laser depilation

Interventions

Laser depilationDEVICE

Laser depilation of natal cleft (pilonidal region)

Laser depilation

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • English and non-English speaking patients
  • All Fitzpatrick skin types
  • Age : 12-20 years
  • Diagnosis of pilonidal disease

You may not qualify if:

  • History of photosensitivity
  • Actively inflamed pilonidal sinus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Results Point of Contact

Title
Dr. Peter Minneci
Organization
The Research Institute at Nationwide Children's Hospital
peter.minneci@nationwidechildrens.org
614-722-3066

Study Officials

  • Peter C Minneci, MD

    Research Institute at Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Laser hair removal
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 19, 2016

Study Start

February 19, 2016

Primary Completion

February 2, 2018

Study Completion

February 2, 2018

Last Updated

March 26, 2019

Results First Posted

March 26, 2019

Record last verified: 2019-03

Locations

US(1)