tapinarof cream, 1% for Dermatitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Dermavant Clinical Trial, Birmingham, AL
Dermatitis+3 More
tapinarof cream, 1% - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a cream can help treat atopic dermatitis.

See full description

Eligible Conditions

  • Dermatitis
  • Dermatitis, Dermatitis Atopic

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether tapinarof cream, 1% will improve 1 primary outcome and 4 secondary outcomes in patients with Dermatitis. Measurement will happen over the course of Baseline to Week 8.

Baseline to Week 8
Mean change in %BSA affected from Baseline at Week 8
Proportion of subjects who have a vIGA-AD score of clear or almost clear (0 or 1) at Week 8
Proportion of subjects with ≥ 75% improvement in EASI from Baseline at Week 8
Proportion of subjects with ≥ 90% improvement in EASI from Baseline at Week 8
Proportion of subjects ≥ 12 years old with a Baseline PP-NRS score ≥ 4 who achieve ≥ 4-point reduction in the PP NRS from Baseline at Week 8

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

tapinarof cream
1 of 2
vehicle cream
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 400 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tapinarof Cream, 1% is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

tapinarof cream
Drug
tapinarof cream, 1%, applied topically once daily
vehicle cream
Drug
vehicle cream, applied topically once daily

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 8
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to week 8 for reporting.

Closest Location

Dermavant Clinical Trial - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex of any age. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent
Male and female subjects ages 2 and above with clinical diagnosis of AD
Subject with atopic dermatitis covering ≥5% and ≤ 35% of the BSA
A vIGA-AD score of ≥3 at screening and baseline
An EASI score of ≥6 at screening and baseline
Must not be pregnant

Patient Q&A Section

Can eczema, infantile be cured?

"It is a rare phenomenon to experience complete resolution of eczema and the majority of patients with infantile eczema do not require any special treatment." - Anonymous Online Contributor

Unverified Answer

What is eczema, infantile?

"Eczema, infantile is a chronic viral disease in which symptoms usually begin in the first 2 years of life. There is no cure. Treatment is symptomatic. Vaccination against rubella and hepatitis B is important." - Anonymous Online Contributor

Unverified Answer

What causes eczema, infantile?

"Eczema and the other inflammatory skin disorders seem to be multifactorial. However eczema and sepsis are the most common cause of death in children and adolescents with eczema, and thus, sepsis and eczema are both listed as health priorities." - Anonymous Online Contributor

Unverified Answer

What are the signs of eczema, infantile?

"When diagnosed, eczema was present in 70 to 80% of patients. Eczema was characterized by itchy skin rash which was aggravated during exposure to irritants (e.g. sweat, soaps, detergents, and cosmetics) and more easily scratched like that occurs during diaper changing. All eczema patients presented an association of eczema with respiratory symptoms (cough, wheezing) and with the allergic rhinitis. Eczema in infants was characterized by the presence of other symptoms like eczema-like skin rash and atopic diseases, most importantly [eosinophilic esophagitis|asthma] and allergic rhinitis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for eczema, infantile?

"Eczema and infantile eczema are typically treated with corticosteroids and antihistamines. There appears to be a need to reconsider the use of anticonvulsants to reduce the risk of seizures on corticosteroid therapy." - Anonymous Online Contributor

Unverified Answer

Is tapinarof cream, 1% typically used in combination with any other treatments?

"In addition to having a measurable anti-inflammatory effect, tapinarof provided the additional benefit of improved patient compliance with the treatment to induce complete skin healing." - Anonymous Online Contributor

Unverified Answer

Has tapinarof cream, 1% proven to be more effective than a placebo?

"For the treatment of the children the study did not support the use of tapinarof cream, as it resulted in slightly more itchiness and more pruritus." - Anonymous Online Contributor

Unverified Answer

What is tapinarof cream, 1%?

"Tapinarof 1%, cream (0.02%) is an adequate treatment regimen in the management of moderate-to-severe to extensive perineal eczema (atrophic perineal dermatitis) associated with significant perineal inflammation. Tapinarof 1%, cream is well tolerated, very beneficial and a very useful addition to the existing therapy." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of eczema, infantile?

"Findings from a recent study suggest that there may exist an idiopathic eczema in some patients with severe lesions and in an infantile onset form in patients with a milder skin lesion and a late onset eczema." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving tapinarof cream, 1%?

"Tapinarof has been studied in a double-blind, randomized clinical trial and a prospective study. These trials are not double-blinded studies because individuals receiving the tapinarof cream were aware of their treatment assignment. For the first trial, the investigators included the placebo control arm for the primary endpoint; for the second trial, the investigators excluded the placebo control arm. These trials indicated that tapinarof has no effect on either the severity or disease status of Eczema, atopic dermatitis, atopic eczema of infancy, or atopic dermatitis of infancy. The studies were also not limited to infants only. Tapinarof application may be beneficial in children and adults." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating eczema, infantile?

"There have been very few new discoveries since 1990. There was one new drug that was successful against eczema. The treatments for eczema that have been developed do not represent a perfect solution because of insufficient knowledge, the problem that most people in the field share about the diseases pathophysiology (aetiology) still needs to be solved because currently available drugs have no benefit for all of those who suffer from eczema." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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