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Topical Agent

tapinarof cream, 1% for Atopic Dermatitis

Phase 3

Waitlist Available

Research Sponsored by Dermavant Sciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 8

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new cream for atopic dermatitis (a skin condition). The cream will be compared to a placebo cream to see if it is more effective and safe.

Eligible Conditions

Atopic Dermatitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You are capable of giving informed consent/assent.

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You have atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old.

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You are male or female and you have clinical diagnosis of Alzheimer's disease.

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The given statement is not a screening criterion. It is a question to gather information about a person's height.

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This criterion doesn't require simplification as it is already plain and simple.

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If you are a woman who could become pregnant and are sexually active, you must use birth control that is considered safe and effective.

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You cannot be pregnant.

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You have atopic dermatitis that affects between 5% to 35% of your body surface area.

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You have a score of 3 or higher on a test called vIGA-AD during screening and baseline evaluations.

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You have a skin condition with an EASI score of 6 or higher at screening and baseline.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of subjects who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) with a Minimum 2-grade Improvement from Baseline to Week 8. Analyses were done using Multiple Imputation.

Secondary study objectives

Mean change in in Percent of Total Body Surface Area (%BSA) affected from Baseline to Week 8.

Percent of subjects with ≥ 75% improvement in Eczema Area and Severity Index (EASI) from Baseline to Week 8. Analyses were done using Multiple Imputation.

Percent of subjects with ≥ 90% improvement in Eczema Area and Severity Index (EASI) from Baseline to Week 8. Analyses were done using Multiple Imputation.

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