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

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

Study Overview

• Status: Withdrawn
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Ivermectin Pill

Detailed Description

OBJECTIVES:

I. Overall response rate of atopic dermatitis in subjects as assessed using Dermatology Life Quality Index (a 10 question questionnaire used to measure the impact of skin disease on the quality of life of an affected person)

SECONDARY OBJECTIVES:

I. , Eczema Area and Severity Index (EASI), Total Severity Scoring (TSS) II. Safety assessment after 8 weeks with 4 weeks of oral treatment. III. VAS (Visual Analogue Scale, an instrument for the assessment of pruritus) at baseline through eight weeks.

OUTLINE:

Patients receiving novel oral agent once a week for 4 weeks in the absence of disease progression or unacceptable toxicity.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Must have at least one lesion of atopic dermatitis (At least 1% Body surface Area).
2. 18 years of age or older.
3. Must be willing to take oral ivermectin once weekly for 4 weeks and monitor over 8 weeks.
4. For women of child bearing potential, a negative urine pregnancy test
5. 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.
6. 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.
7. Has signed and dated the current Institutional Review Board approved informed consent document.
8. Must be able to read and speak English fluently.

Exclusion Criteria:

1. Is currently participating or has participated in another interventional clinical study in the past 2 weeks;
2. Is age <18 years old.
3. Has had known or previous hypersensitivity or allergic reactions to oral ivermectin before;
4. 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;
5. Taking any medication known to interact with ivermectin like Dasabuvir (theoretical) or warfarin (probable).
6. Is planning a trip to a sunny climate, to use tanning booths or use other UV sources throughout the course of this study;
7. Has a history of hypersensitivity to any substance in investigational preparation;
8. 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;
9. Is currently pregnant or breastfeeding.
10. 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;
11. 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
12. History of congestive heart failure; cardiac arrhythmias; or other findings of ventricular dysfunction.
13. History of current evidence of malabsorption or liver disease.
14. Cannot read and speak English fluently.
15. Does not have at least 1% body surface area with lesional atopic dermatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral treatment; 12mg oral ivermectin treatment taken once a week for four weeks	Drug: Ivermectin Pill; oral anti-parasitic agent taken as a weekly dose for four weeks; Other Names: Stromectol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLQI	Patient Dermatology Life Quality Index	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EASI	Eczema area and severity index	8 weeks
TSS	Total Sum Score of lesion	8 weeks
IGA	Investigator Global Analysis	8 weeks
VAS for Pruritis	Visual Analogue Scale for Pruritis	8 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Director: Kavita Sarin, MD, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: IRB-46486

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No