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

Phase 2

Withdrawn

• Conditions: Atopic Dermatitis
• Interventions: Drug: Ivermectin Pill

• Registration Number: NCT03553615
• Lead Sponsor: Stanford University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-12-02
• Study Start: 2030-12-01
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral treatment	Ivermectin Pill	12mg oral ivermectin treatment taken once a week for four weeks

Primary Outcome Measures

Name	Time	Method
DLQI	8 weeks	Patient Dermatology Life Quality Index

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States