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

NCT ID: NCT03553615

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2030-12-01
• Study Completion Date: 2030-12-31

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral treatment

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

Group Type: EXPERIMENTAL

Ivermectin Pill

Intervention Type: DRUG

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

Interventions

Ivermectin Pill

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

Intervention Type: DRUG

Other Intervention Names

Stromectol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Kavita Sarin

Assistant Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kavita Sarin, MD, PhD

Role: STUDY_DIRECTOR

Stanford University

Locations

Stanford Hospital and Clinics

Stanford, California, United States

Countries

United States

Other Identifiers

IRB-46486

Identifier Type: -

Identifier Source: org_study_id