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

Primary Purpose

Atopic Dermatitis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ivermectin Pill
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral treatment

Arm Description

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

Outcomes

Primary Outcome Measures

DLQI
Patient Dermatology Life Quality Index

Secondary Outcome Measures

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

Full Information

First Posted
May 30, 2018
Last Updated
April 8, 2019
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03553615
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Limited clinical capacity
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Oral Ivermectin
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral treatment
Arm Type
Experimental
Arm Description
12mg oral ivermectin treatment taken once a week for four weeks
Intervention Type
Drug
Intervention Name(s)
Ivermectin Pill
Other Intervention Name(s)
Stromectol
Intervention Description
oral anti-parasitic agent taken as a weekly dose for four weeks
Primary Outcome Measure Information:
Title
DLQI
Description
Patient Dermatology Life Quality Index
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
EASI
Description
Eczema area and severity index
Time Frame
8 weeks
Title
TSS
Description
Total Sum Score of lesion
Time Frame
8 weeks
Title
IGA
Description
Investigator Global Analysis
Time Frame
8 weeks
Title
VAS for Pruritis
Description
Visual Analogue Scale for Pruritis
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have at least one lesion of atopic dermatitis (At least 1% Body surface Area). 18 years of age or older. Must be willing to take oral ivermectin once weekly for 4 weeks and monitor over 8 weeks. For women of child bearing potential, a negative urine pregnancy test 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. 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. Has signed and dated the current Institutional Review Board approved informed consent document. Must be able to read and speak English fluently. Exclusion Criteria: Is currently participating or has participated in another interventional clinical study in the past 2 weeks; Is age <18 years old. Has had known or previous hypersensitivity or allergic reactions to oral ivermectin before; 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; Taking any medication known to interact with ivermectin like Dasabuvir (theoretical) or warfarin (probable). Is planning a trip to a sunny climate, to use tanning booths or use other UV sources throughout the course of this study; Has a history of hypersensitivity to any substance in investigational preparation; 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; Is currently pregnant or breastfeeding. 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; 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 History of congestive heart failure; cardiac arrhythmias; or other findings of ventricular dysfunction. History of current evidence of malabsorption or liver disease. Cannot read and speak English fluently. Does not have at least 1% body surface area with lesional atopic dermatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kavita Sarin, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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

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