Trial Outcomes & Findings for Pilot Study of Laser Hair Depilation for Pilonidal Disease (NCT NCT02778152)

Last Updated: 2019-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

five months

Results posted on

2019-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Laser Group Received 5 laser hair removal treatments spaced every 4 to 6 weeks
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Laser Hair Depilation for Pilonidal Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laser Depilation n=13 Participants 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. Laser depilation: Laser depilation of natal cleft (pilonidal region)
Age, Continuous	16.6 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: five months

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.

Outcome measures

Outcome measures
Measure	Laser Group n=13 Participants Received 5 laser hair removal treatments spaced every 4 to 6 weeks
Tolerability of Laser Treatment	2 score on a scale Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: five months

Incidence of skin burn within the first 48 hours after each of the 5 treatments

Outcome measures

Outcome measures
Measure	Laser Group n=13 Participants Received 5 laser hair removal treatments spaced every 4 to 6 weeks
Number of Participants Experiencing Second Degree Burns Post-Treatment	0 Participants

Adverse Events

Laser Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter Minneci

The Research Institute at Nationwide Children's Hospital

Phone: 614-722-3066

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place