Open-label Pilot Clinical Trial of Oral Ivermectin to Treat Atopic Dermatitis

NCT03553615 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB-46486
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot trial studies how well a novel oral therapeutic agent performs to treat patients with atopic dermatitis, particularly facial dermatitis.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• DLQI

  Patient Dermatology Life Quality Index

  8 weeks

Secondary Outcomes (4)

• EASI

  8 weeks

• TSS

  8 weeks

• IGA

  8 weeks

• VAS for Pruritis

  8 weeks

Study Arms (1)

Oral treatment

EXPERIMENTAL

12mg oral ivermectin treatment taken once a week for four weeks

Drug: Ivermectin Pill

Interventions

Ivermectin Pill DRUG

oral anti-parasitic agent taken as a weekly dose for four weeks

Also known as: Stromectol

Oral treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have at least one lesion of atopic dermatitis (At least 1% Body surface Area).
• years of age or older.
• Must be willing to take oral ivermectin once weekly for 4 weeks and monitor over 8 weeks.
• For women of child bearing potential, a negative urine pregnancy test
• Women of child bearing potential are expected to use an effective method of birth control while participating in the study and for 1 month after taking the last dose.
• For male subjects with female partners of childbearing potential, agreement to use adequate contraception while participating in the study and for 1 month after taking the last dose.
• Has signed and dated the current Institutional Review Board approved informed consent document.
• Must be able to read and speak English fluently.

You may not qualify if:

• Is currently participating or has participated in another interventional clinical study in the past 2 weeks;
• Is age \<18 years old.
• Has had known or previous hypersensitivity or allergic reactions to oral ivermectin before;
• Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results;
• Taking any medication known to interact with ivermectin like Dasabuvir (theoretical) or warfarin (probable).
• Is planning a trip to a sunny climate, to use tanning booths or use other UV sources throughout the course of this study;
• Has a history of hypersensitivity to any substance in investigational preparation;
• Has any clinically significant medical condition or laboratory abnormality that would, in the opinion of the Investigator, put the patient at undue risk or interfere with the interpretation of the study results;
• Is currently pregnant or breastfeeding.
• Has other skin conditions that might interfere with Atopic Dermatitis diagnosis and/or evaluation (i.e. psoriasis current active viral, bacterial and fungal skin infections) as assessed by the Investigator;
• Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation
• History of congestive heart failure; cardiac arrhythmias; or other findings of ventricular dysfunction.
• History of current evidence of malabsorption or liver disease.
• Cannot read and speak English fluently.
• Does not have at least 1% body surface area with lesional atopic dermatitis

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Kavita Sarin, MD, PhD

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Model Details: Oral Ivermectin

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 12, 2018
• Study Start (Estimated): December 1, 2030
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)