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Trial record 30 of 104 for:    IVERMECTIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553615
Recruitment Status : Withdrawn (Limited clinical capacity)
First Posted : June 12, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Kavita Sarin, 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.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Ivermectin

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553615


Locations
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United States, California
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Study Director: Kavita Sarin, MD, PhD Stanford University

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

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