The effect of isotretinoin on mucosal wound healing in patients with chronic sinusitis: a pilot study.

Phase 1

Recruiting

• Conditions: Respiratory - Other respiratory disorders / diseases; Chronic sinusitis; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12615001066572
• Lead Sponsor: Associate Professor Richard Douglas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Patients newly diagnosed with CRS, are eligible for sinus surgery and on the waiting list for endoscopic sinus surgery, but not yet undergone surgery.

Patients providing fully informed consent to participate in this study.

Exclusion Criteria

Patients who are acutely unwell.
Patients with cystic fibrosis.
Patients with a history of previous nasal surgery.
Male patients less than 16 years of age
Female patients less than 45 years of age (owing to isotretinoin teratogenicity risk)
Immunodeficiency (congenital or acquired)
Congenital mucociliary problems (e.g. primary ciliary dyskinesia)
Non-invasive and invasive fungal sinus disease
Systemic vasculitis and granulomatous diseases
History of cocaine abuse;
Patients requiring sinus surgery for neoplasia
Patients unable to consent (e.g. lack of mental capacity)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiology<br>The swabs taken before and after medical therapy will be compared. Alongside conventional culture methods, samples will also be subjected to PCR amplification of the bacterial 16S ribosomal RNA (16S rRNA) genes.[At times 0, 2 weeks (surgery) and 4 weeks (post op).];Cytokines<br>Levels of important inflammatory cytokines will be measured in the mucus of the patients using a cytokine ELISA.[At times 0, 2 weeks (surgery) and 4 weeks (post op).];Histology<br>Composite outcomes - Analysis will be done for cilial recovery, collagen content, goblet cell recovery, epithelial thickness, mucosal thickness, immune cells and bacterial cells. Comparisons will be made between injured and uninjured tissue.[performed on sample collected at the time of surgery (2 weeks after starting study medication or placebo)]

Secondary Outcome Measures

Name	Time	Method
Patient reported symptom scores (Sinonasal Outcome Test –22)[At times 0, 2 weeks (surgery) and 4 weeks (post op).];Endoscopic scoring (Lund-Kennedy Endoscopic Score).[At times 0, 2 weeks (surgery) and 4 weeks (post op).];pH of mucus will be measured using a pH indicator[At times 0, 2 weeks (surgery) and 4 weeks (post op).]