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Topical Agent

Tapinarof cream, 1% for Atopic Dermatitis

Phase 2
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 28 (pk sample collected at pre-dose and at 1, 3, and 5 hours after dosing)
Awards & highlights

Study Summary

This trial will assess the exposure and safety of a new cream for treating eczema in children.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 28 (pk samples collected at pre-dose and at 1, 3, and 5 hours after dosing)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 28 (pk samples collected at pre-dose and at 1, 3, and 5 hours after dosing) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values and Vital Signs
Number of Participants that Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with irritation as assessed by the Local Tolerability Scale (LTS)
+4 more
Secondary outcome measures
Change from Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
Mean change in Eczema Area and Severity Index EASI from baseline to Day 28
Mean change in Percent of Total Body Surface Area (%BSA) affected from Baseline to Day 28
+7 more

Side effects data

From 2020 Phase 2 trial • 21 Patients • NCT04042103
19%
Headache
19%
Folliculitis
10%
Back pain
10%
Pruritus
5%
Pain
5%
Pancreatitis
5%
Dehydration
5%
Fatigue
5%
Nausea
5%
Diabetes mellitus
5%
Chest Pain
5%
Abdominal Pain
5%
Nasopharyngitis
5%
Furuncle
5%
pancreatitis
5%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tapinarof (DMVT-505) Cream, 1%

Trial Design

1Treatment groups
Experimental Treatment
Group I: tapinarof creamExperimental Treatment1 Intervention
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tapinarof cream, 1%
2021
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Dermavant Sciences, Inc.Lead Sponsor
5 Previous Clinical Trials
1,166 Total Patients Enrolled
Diana VillalobosStudy DirectorDermavant Sciences, Inc.
4 Previous Clinical Trials
1,874 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
Massachusetts
California
Other
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Therapeutic Innovation & Regulatory ScienceJournal
Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products
Bashaw, Edward Dennis, Doanh C. Tran, Chinmay G. Shukla, and Xiaomei Liu. 2015. “Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products”. Therapeutic Innovation & Regulatory Science. Springer Science and Business Media LLC. doi:10.1177/2168479014539157.
New England Journal of MedicineJournal
Atopic Dermatitis
Bieber, Thomas. 2008. “Atopic Dermatitis”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmra074081.
Pediatric DermatologyJournal
The Burden of Atopic Dermatitis: Impact on the Patient, Family, and Society
Carroll, Christie L., Rajesh Balkrishnan, Steven R. Feldman, Alan B. Fleischer, and Janeen C. Manuel. 2005. “The Burden of Atopic Dermatitis: Impact on the Patient, Family, and Society”. Pediatric Dermatology. Wiley. doi:10.1111/j.1525-1470.2005.22303.x.
International Journal of Molecular SciencesJournal
Aryl Hydrocarbon Receptor in Atopic Dermatitis and Psoriasis
Furue, Masutaka, Akiko Hashimoto-Hachiya, and Gaku Tsuji. 2019. “Aryl Hydrocarbon Receptor in Atopic Dermatitis and Psoriasis”. International Journal of Molecular Sciences. MDPI AG. doi:10.3390/ijms20215424.
~11 spots leftby Apr 2025
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