Atopic DermatitisPhase 2NCT03553615
Open-label Pilot Clinical Trial of Oral Ivermectin to Treat Atopic Dermatitis
A Phase 2 study testing Ivermectin Pill in people with Atopic Dermatitis, run by Stanford University at 1 site in United States.
Trial summary
This pilot trial studies how well a novel oral therapeutic agent performs to treat patients with atopic dermatitis, particularly facial dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Ivermectin Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2030to Dec 2030
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Stanford, California, 94305
About this study
This pilot trial studies how well a novel oral therapeutic agent performs to treat patients with atopic dermatitis, particularly facial dermatitis.
Read the detailed description
OBJECTIVES:
- 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:
- , 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
- Being tested
- Ivermectin Pill
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin PillDrug
Also called Stromectol
oral anti-parasitic agent taken as a weekly dose for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Oral treatment | Experimental | 12mg oral ivermectin treatment taken once a week for four weeks Receives: Drug: Ivermectin Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLQI
Patient Dermatology Life Quality Index
Measured: 8 weeks
Secondary outcomes (4)
EASI
Eczema area and severity index
Measured: 8 weeks
TSS
Total Sum Score of lesion
Measured: 8 weeks
IGA
Investigator Global Analysis
Measured: 8 weeks
VAS for Pruritis
Visual Analogue Scale for Pruritis
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start1 Dec 2030 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Why it stopped: Limited clinical capacity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Oral Ivermectin
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kavita Sarin, Stanford University
- Investigators
- Kavita Sarin, MD, PhD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553615
- Sponsor's protocol ID
- IRB-46486
- Status last verified
- Nov 2024
- First submitted
- 30 May 2018
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Pilot Clinical Trial of Oral Ivermectin to Treat Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03553615
- Acronym / sponsor ID
- IRB-46486
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Limited clinical capacity
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Dec 2030 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot trial studies how well a novel oral therapeutic agent performs to treat patients with atopic dermatitis, particularly facial dermatitis.
Detailed description
OBJECTIVES:
- 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:
- , 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Oral Ivermectin
| Arm | Type | Receives |
|---|---|---|
| Oral treatment | Experimental | Drug: Ivermectin Pill12mg oral ivermectin treatment taken once a week for four weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivermectin PillAlso: Stromectoloral anti-parasitic agent taken as a weekly dose for four weeks | Drug | Oral treatment |
Primary outcome
DLQI
Time frame: 8 weeks
Patient Dermatology Life Quality Index
4 secondary outcomes
EASI
Time frame: 8 weeks
TSS
Time frame: 8 weeks
IGA
Time frame: 8 weeks
VAS for Pruritis
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kavita Sarin, MD, PhD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivermectin Pill in people with Atopic Dermatitis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLQI (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.