Tapinarof Cream for Atopic Dermatitis

(Adoring Trial)

Recruiting at 49 trial locations

Overseen By Clinical Lead Late-Stage Clinical Development

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Organon and Co

Disqualifiers: Neurological disorder, Cardiac disorder, Immunocompromised, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cream called tapinarof for babies and toddlers with atopic dermatitis, a common skin condition that causes itchy and inflamed skin. The study aims to determine if the cream is safe and effective for children between 3 and 23 months old. Participants will receive either the tapinarof cream or a placebo cream (a cream with no active ingredient) to compare results. Babies with at least 5% of their body covered in atopic dermatitis may qualify for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not clearly state if you need to stop taking your current medications. However, it mentions that the use of certain medications is prohibited, so you may need to discuss your current medications with the trial team.

Is there any evidence suggesting that tapinarof cream is likely to be safe for humans?

Research shows that tapinarof cream is generally safe and well-tolerated for treating atopic dermatitis in children aged 2 years and older. Studies have found that it has a good safety record, with most people not experiencing serious side effects. However, there is a small chance of some unwanted effects. While some might notice minor side effects, they are usually not severe. Overall, the cream has been used safely in children and is now being tested for even younger ages, from 3 to 23 months. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tapinarof cream is unique because it uses a novel mechanism of action by targeting the aryl hydrocarbon receptor (AhR) pathway, which plays a role in reducing inflammation and promoting skin health. Unlike many standard treatments for atopic dermatitis, such as corticosteroids and calcineurin inhibitors, Tapinarof is a non-steroidal option, potentially reducing the risk of side effects associated with long-term steroid use. Researchers are excited about its potential to provide a safer, effective alternative for managing atopic dermatitis with a once-daily topical application.

What evidence suggests that tapinarof cream might be an effective treatment for atopic dermatitis?

Research has shown that tapinarof cream effectively treats atopic dermatitis, a type of eczema. Earlier studies demonstrated that using 1% tapinarof cream once daily for eight weeks significantly reduced the condition's severity. It also improved outcomes such as IGA (a doctor’s assessment of the condition) and EASI-75 (a measure of eczema severity). Improvements appeared as early as two weeks and continued through eight weeks. The treatment consistently delivered meaningful results for people of different ages and varying severity levels, and patients tolerated it well. Overall, tapinarof cream has proven effective for both children and adults with atopic dermatitis. Participants in this trial will receive either the tapinarof cream or a vehicle cream as a placebo comparator. ^{3 4 5 6 7}

Who Is on the Research Team?

Clinical Lead Late-Stage Clinical Development

Principal Investigator

Organon and Co

Are You a Good Fit for This Trial?

This clinical trial is for young children aged between 3 months and less than 24 months who have atopic dermatitis. Specific eligibility details are not provided, but typically participants must meet certain health criteria to be included.

Inclusion Criteria

Legal guardian or primary caregiver is willing and able to sign informed consent form before any study-related activities

Legal guardian or primary caregiver is able and willing to adhere to protocol requirements

My child is between 3 months and less than 24 months old.

Exclusion Criteria

History of sudden infant death in a sibling

Significant neurological disorder or history of seizure

Use of prohibited medication(s) or procedure(s)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Treatment

Participants receive either tapinarof cream or vehicle cream applied topically once daily

8 weeks

Regular visits for assessment

Open-Label Treatment

Participants receive tapinarof cream applied topically once daily

56 weeks

Regular visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tapinarof Cream

Trial Overview

The study is testing the safety and effectiveness of a cream called Tapinarof at a concentration of 1%. It's being compared with a vehicle cream (a placebo without the active drug) in babies and toddlers with skin inflammation due to atopic dermatitis.

How Is the Trial Designed?

Group I: Tapinarof cream Experimental Treatment 1 Intervention

Tapinarof cream, 1%, applied topically once daily

Group II: Vehicle cream Placebo Group 1 Intervention

Vehicle cream is applied topically once daily for up to 8-weeks.

Who Is Running the Clinical Trial?

Organon and Co

Lead Sponsor

Trials

492

Recruited

1,733,000+

Juan Camilo Arjona Ferreira

Organon and Co

Chief Medical Officer since 2023

MD

Kevin Ali

Organon and Co

Chief Executive Officer since 2021

MBA from Santa Clara University, BA from the University of California, Berkeley

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12494503/

Efficacy and Safety of Tapinarof for Atopic Dermatitis

In conclusion, 1% tapinarof cream applied once daily for eight weeks reduced disease severity, improved clinical outcomes (IGA success, EASI-75 ...

2.

organon.com

organon.com/news/new-data-show-early-and-consistent-response-to-vtama-tapinarof-cream-1-in-children-aged-2-with-atopic-dermatitis-including-those-with-associated-comorbidities/

New Data Show Early and Consistent Response to VTAMA ...

Improvement in eczema severity, as measured by EASI scores, was observed as early as week 2 and sustained through week 8 (with comorbidities: ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0190962225021309

Results from ADORING 3, a 48-week phase 3 open-label ...

In 2 pivotal phase 3 trials, tapinarof demonstrated significant efficacy and was well tolerated in patients down to age 2 years with atopic dermatitis.

4.

jaad.org

jaad.org/article/S0190-9622(24)00755-2/fulltext

Tapinarof cream 1% once daily: Significant efficacy in the ...

Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age.

5.

jacionline.org

jacionline.org/article/S0091-6749(23)01531-2/fulltext

Tapinarof Cream 1% Once Daily: Consistent Efficacy ...

Tapinarof cream 1% QD demonstrated consistent, clinically meaningful efficacy across disease severity and age subgroups, and was well tolerated.

6.

vtamahcp.com

vtamahcp.com/atopic-dermatitis/safety-profile/

Safety - VTAMA® (tapinarof) cream, 1% (50)

Safe and well tolerated for patients with atopic dermatitis down to 2 years of age2. Not actual patients/caregiver. Favorable safety profile. Adverse ...

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2024/215272s002lbl.pdf

VTAMA® cream - accessdata.fda.gov

The safety and efficacy of VTAMA cream for the topical treatment of atopic dermatitis have been established in pediatric patients 2 years of age and older. Use ...