Clinical trial NCT03553615: Open-label Pilot Clinical Trial of Oral Ivermectin to Treat Atopic Dermatitis
Official title: Open-label Pilot Clinical Trial of Oral Ivermectin to Treat Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Oral Ivermectin
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: DLQI
timeFrame: 8 weeks
Secondary outcomes:
measure: EASI
timeFrame: 8 weeks
measure: TSS
timeFrame: 8 weeks
measure: IGA
timeFrame: 8 weeks
measure: VAS for Pruritis
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Kavita Sarin, MD, PhD
role: STUDY_DIRECTOR
References: