Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP

Recurrent Respiratory Papillomatosis Clinical Trial

Official title:

A Multi-Center, Randomized, Controlled Trial of the Pulsed Dye Laser for Juvenile Onset Recurrent Respiratory Papillomatosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550914
• Other study ID #: 07-01-005
• Secondary ID: 07-01-005
• Status: Completed
• Phase: N/A
• First received: October 26, 2007
• Last updated: July 6, 2010
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: July 2010
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether the 585-nm pulse dye laser can decrease the time interval between surgeries and improve voice outcomes in children with severe RRP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

Inclusion Criteria:

1. Immunocompetent children ages 1-12 with symptomatic JORRP requiring operative intervention

2. Children who have historically required at least four surgeries in the year preceding enrollment to treat laryngeal JORRP

Exclusion Criteria:

1. Children who have required fewer than four procedures to treat laryngeal JORRP in the year prior to enrollment.

2. Children who are currently receiving adjuvant therapies for JORRP including cidofovir, interferon, indole-3-carbinol or Hsp-E7.

3. Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language.

4. Children whose families do not sign an informed consent to enter into the study.

5. Children whose families anticipate discontinuing care at a participating institution during the study period

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Papilloma
• Papillomavirus Infections
• Recurrent Respiratory Papillomatosis
• Respiratory Tract Infections

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	Rady Children's Hospital	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary	Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis		One Year	No
Secondary	Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score		One Year	No