Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-21
SponsorNemours Children's Clinic

About this trial

Pilot randomized trial assessing the effectiveness of laser hair depilation on pilonidal disease recurrence in patients with darker skin color

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 10-21 years

Diagnosis of pilonidal disease

Fitzpatrick skin type IV, V, or VI

Disqualifiers

History of photosensitivity

Actively inflamed pilonidal sinus (will be offered enrollment upon resolution).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laser hair depilation

    Procedure/Surgery

    Laser hair depilation treatment with Nd:YAG laser every 4-6 weeks to obtain a total of 5 treatments. Similar to the control group, they will also receive the "best recommended standard care" including teaching on hair removal techniques and asked to perform either chemical or mechanical depilation as needed between treatments.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Standard CareNo intervention 0 interventions
Group B: Laser groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease Recurrence

Disease recurrence is defined as development of a new pilonidal abscess, folliculitis, or draining sinus after treatment, which would require antibiotic therapy, additional surgical incision and drainage, or excision. development of an abscess, folliculitis, or draining sinus which requires treatment (antibiotic therapy, surgical incision and drainage, or excision).

Time frame
1 year

Secondary outcomes

1

Disability days

Disability days will be defined as all days in which the patient was not able to participate in all normal activities secondary to pilonidal disease within 1 year.

Time frame
1 year
2

health-related quality of life (HRQOL) and healthcare satisfaction

The PedsQLTM Quality of Life Inventory: Child and Parent Report questionnaire will be used to assess HRQOL. The PedsQLTM Healthcare Satisfaction Generic Module: Parent Report will be used to assess healthcare satisfaction.

Time frame
1 year
3

Rates of pilonidal disease-related complications

Complications include physician, Emergency Department (ED), and urgent care visits, hospital admissions, and additional surgical procedures.

Time frame
1 year
4

Rates of pilonidal disease-related procedures

Procedures will include incision and drainage procedures and surgical excisions, and their respective post-operative complications

Time frame
1 year

Other outcomes

Sponsors and contacts

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Nemours Children's Clinic

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator