For Healthcare Professionals Help your adult and pediatric patients who suffer from moderate to severe eczema

Sponsor Dermavant Sciences, Inc.

Indication & Protocol Title Atopic dermatitis (AD) — A double-blind, randomized, vehicle-controlled, multicenter study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared with vehicle control cream in subjects aged 2 years and above with AD.

Phase: 3

Number of Study Centers: Up to 60 in the US and Canada

Patient Population Patients aged 2 years and above

Number of Patients Approximately 400 subjects randomized at a 2:1 ratio to receive tapinarof cream, 1% (approximately 267 subjects) or vehicle cream (approximately 133 subjects)

Investigational Drug & Administration DMVT-505 (tapinarof cream, 1%)
Topical, once daily

Primary Objective To evaluate the efficacy of tapinarof cream, 1% once daily (QD) compared with vehicle control in subjects with atopic dermatitis (AD)

Primary Efficacy Endpoint Proportion of subjects who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score of clear or almost clear (0 or 1) at Week 8

Inclusion / Exclusion Criteria

Note: Additional criteria will apply*

  • Male and female subjects aged 2 years and above with clinical diagnosis of eczema

  • Eczema covering ≥ 5% and ≤ 35% of the BSA; scalp should be excluded from the BSA calculation to determine eligibility during Screening, at Baseline, and for all efficacy assessments
    NOTE: Subjects with disease only on palms and soles are not eligible

  • Have eczema diagnosed for at least 6 months for those 6 years old and above or 3 months for those 2 to 5 years old

  • If under 18 have a parent(s) or legal representative capable of giving written informed consent/assent

  • Immunocompromised (e.g., lymphoma, acquired immunodeficiency syndrome) or a chronic or acute systemic infection (bacterial or fungal)

  • Significant dermatologic or inflammatory condition other than eczema that would make it difficult to interpret data or study assessments

  • Current or chronic history of liver disease or cancer within the past 5 years (except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix)

  • Use of any prohibited medications or procedures within specified periods prior to the Baseline visit or during the course of the study; washout periods for prohibited medications are specified in the protocol

  • Previous known participation in a clinical study with tapinarof and/or a history of sensitivity to the study medications or components thereof

Start the Conversation

Please consider sharing a link and discussing the ADORING study with your adult and pediatric patients who suffer from moderate to severe eczema and are looking for a potential new topical non-steroidal solution.

Please note that any patients you refer will remain in your primary care while they participate.

Am I Eligible?