Intranasal Platelet-Rich Plasma With or Without Topical Insulin for Post-Inflammatory Anosmia

NCT07383415 | Not Yet Recruiting

• 1 other identifier: H25-02495
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates whether adding topical insulin to intranasal platelet-rich plasma (PRP) improves smell recovery in adults with post-inflammatory anosmia. Participants will be randomly assigned to receive either intranasal PRP combined with topical insulin or intranasal PRP alone. Changes in olfactory function will be assessed over time to compare the effectiveness and safety of the two treatments.

Conditions

Anosmia; Inflammatory Anosmia

Keywords

PRP; PRP-INSULIN

Outcome Measures

Primary Outcomes (1)

• Change in Olfactory Function

  Change in olfactory function from baseline as measured using a validated smell identification test.

  Baseline to 12 months post-intervention

Study Arms (2)

PRP Plus Topical Insulin

ACTIVE COMPARATOR

Participants receive intranasal platelet-rich plasma in combination with topical insulin.

Biological: Intranasal PRP Plus Topical Insulin

PRP Alone

PLACEBO COMPARATOR

Participants receive intranasal platelet-rich plasma with saline instead of insulin.

Biological: Intranasal PRP Plus Saline (Placebo)

Interventions

Intranasal PRP Plus Topical Insulin BIOLOGICAL

Autologous platelet-rich plasma administered intranasally with the addition of topical insulin applied to the olfactory cleft.

PRP Plus Topical Insulin

Intranasal PRP Plus Saline (Placebo) BIOLOGICAL

Autologous platelet-rich plasma administered intranasally with saline applied in place of topical insulin as a placebo comparator.

PRP Alone

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with olfactory dysfunction despite olfactory training therapy
• Loss of smell within the past 5 years
• Loss of smell occurred after an infection
• Platelet count is over 150,000 platelets per microliter

You may not qualify if:

• Have a history of or currently have sinonasal tumours Have a history of surgery or radiotherapy for the base of your skull Have been treated with antibiotics in the past month before surgery Have a condition called systemic vasculitis or any bleeding disorder Have a suspected or known allergy to insulin or PRP or Platelet Lysate (PL) Have inhaled drugs (i.e cocaine) in the past 6 months of your enrollment Smell loss is due to a head trauma or after surgery Unable to complete the Sniffin Stick Smell test or questionnaires

Sponsors & Collaborators

• Amin Javer: lead

MeSH Terms

Conditions

Anosmia

Interventions

Insulin; Sodium Chloride

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Amin Javer, MD

CONTACT

604-806-9926; sinusdoc@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01