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

• ClinicalTrials.gov Identifier: NCT03553615
• Recruitment Status: Withdrawn
• First Posted: June 12, 2018
• Last Update Posted: April 10, 2019
• Sponsor: Stanford University
• Information provided by (Responsible Party): Kavita Sarin, Stanford University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Ivermectin Pill	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Oral Ivermectin
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-label Pilot Clinical Trial of Oral Ivermectin to Treat Atopic Dermatitis
• Estimated Study Start Date: December 2018
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: December 2020

Arms and Interventions

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 Name: Stromectol

Outcome Measures

Primary Outcome Measures :

1. DLQI [ Time Frame: 8 weeks ]
   Patient Dermatology Life Quality Index

Secondary Outcome Measures :

1. EASI [ Time Frame: 8 weeks ]
   Eczema area and severity index
2. TSS [ Time Frame: 8 weeks ]
   Total Sum Score of lesion
3. IGA [ Time Frame: 8 weeks ]
   Investigator Global Analysis
4. VAS for Pruritis [ Time Frame: 8 weeks ]
   Visual Analogue Scale for Pruritis

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

Stanford Hospital and Clinics

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Study Director: Kavita Sarin, MD, PhD; Stanford University

More Information

• Responsible Party: Kavita Sarin, Assistant Professor of Dermatology, Stanford University
• ClinicalTrials.gov Identifier: NCT03553615
• Other Study ID Numbers: IRB-46486
• First Posted: June 12, 2018
• Last Update Posted: April 10, 2019
• Last Verified: April 2019

• 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

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Ivermectin; Antiparasitic Agents; Anti-Infective Agents