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Atopic DermatitisPhase 3AdoringNCT07265479

A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

A Phase 3 study testing Tapinarof cream, 1% in people with Atopic Dermatitis, run by Organon and Co at 46 sites in 2 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis. Read more about this study

Who is it for?
Ages 3 to 23 months
Conditions the study is for
Atopic Dermatitis
What is being tested?
Tapinarof cream, 1%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
187 participants
Where
46 sitesin 2 countries
Study dates
29 Dec 2025to Aug 2027
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 23 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants and toddlers born at term (≥37 weeks of gestational age) that are 3 months to <24 months of age at the Screening visit.
  • Clinical diagnosis of atopic dermatitis (AD), AD covering >5% Body Surface Area (BSA) and validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2, 3 or 4
  • 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

Who cannot join

  • Significant neurological disorder or history of seizure
  • Know clinically significant cardiac rhythm or cardiac disorder
  • History of sudden infant death in a sibling
  • Clinically significant chromosome abnormality
  • History of or ongoing serious illness or medical, physical or psychiatric condition(s) that may interfere with the participant's participation
  • Diseases that could cause pruritic and/or sleep disruption
Show all 10Show fewer
  • Immunocompromised
  • Current chronic or acute infection requiring treatment
  • Use of prohibited medication(s) or procedure(s)
  • Use of prohibited medications by breastfeeding mother if breastfeeding participant

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

United States36 sites
  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas, 77401

  • AllerVie Clinical Research

    Birmingham, Alabama, 35209

  • Skin Care Research, LLC.

    Boca Raton, Florida, 33486

  • Equity Medical, LLC

    Bowling Green, Kentucky, 42104

  • Dermatology Trial Associates

    Bryant, Arkansas, 72022

  • Clarity Dermatology

    Castle Rock, Colorado, 80109

  • The University of North Carolina Dermatology and Skin Cancer Center

    Chapel Hill, North Carolina, 27516

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Cleaver Medical Group Dermatology, Inc

    Cumming, Georgia, 30040

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230

  • Dermatologists of Central States, LLC

    Fairborn, Ohio, 45324

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • APEX Clinical Trials

    Jacksonville, Florida, 32256

  • Forest Hills Dermatology Group

    Kew Gardens, New York, 11415

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Ada West Research

    Meridian, Idaho, 83646

  • Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112

  • Bobby Buka MD, PC

    New York, New York, 10012

  • National Allergy and Asthma Research, LLC.

    North Charleston, South Carolina, 29420

  • Allergy Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana, 46168

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Skin Cancer and Dermatology Institute

    Reno, Nevada, 89509

  • SKY Integrative Medical Center

    Ridgeland, Mississippi, 39157

  • Lawrence J Green, MD LLC

    Rockville, Maryland, 20850

  • Integrative Skin Science and Research

    Sacramento, California, 95815

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Allergy and Asthma Medical Group and Research Center

    San Diego, California, 92123

  • Endeavor Health Clinical Trials Center

    Skokie, Illinois, 60077

  • Stryde Research - Epiphany Dermatology

    Southlake, Texas, 76092

  • Dermatology Specialists of Spokane

    Spokane, Washington, 99202

  • Equity Medical, LLC

    The Bronx, New York, 10455

  • Clinical Trials Research Institute

    Thousand Oaks, California, 91320

  • TruDerm Research

    Wellington, Florida, 33449

Other trials in United States

Canada10 sites
  • Halton Pediatric Allergy

    Burlington, Ontario, L7L 6W6

  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1

  • Maritime Dermatology

    Halifax, Nova Scotia, B3K 5R3

  • Triple A Lab Inc.

    Hamilton, Ontario, L8S 1G5

  • Allergy Research Canada Inc.

    Niagara Falls, Ontario, L2H 1C4

  • CARe Clinic (Central Alberta Research Clinic)

    Red Deer, Alberta, T4P 1K4

  • Dr. Rachel Asiniwasis Medical Professional Corporation

    Regina, Saskatchewan, S4V 1R9

  • Skinsense Medical Research

    Saskatoon, Saskatchewan, S7K 2C1

  • Dr. Chih-Ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7

  • Manitoba Allergy Research Inc.

    Winnipeg, Manitoba, R3J 0S9

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.

Being tested
Tapinarof cream, 1%, Vehicle Cream
Keywords
Pediatric Atopic Dermatitis, Eczema, tapinarof, topical
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tapinarof cream, 1%Drug

    Also called OG-0505, DMVT-505, GSK2894512A, GSK28994512

    Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed.

  • Vehicle CreamDrug

    Applied topically once daily to lesions on participant's skin during the Double-Blind period.

Study groups in NCT07265479
Study groupRoleWhat they receive
Tapinarof creamExperimentalTapinarof cream, 1%, applied topically once daily
Receives: Drug: Tapinarof cream, 1%
Vehicle creamPlacebo comparatorVehicle cream is applied topically once daily for up to 8-weeks.
Receives: Drug: Vehicle Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8

    The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.

    Measured: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

  2. Percentage of participants who enter with or achieve have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement at least once during the Open-Label Period

    The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint.. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.

    Measured: Baseline to the end of the Open-Label Period, up to 56 weeks.

Secondary outcomes (11)
  1. Percentage of participants with ≥ 75% improvement in Eczema Area and Severity Index (EASI) Score from Baseline to Week 8.

    The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the %BSA affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. A higher EASI score represents more severe disease.

    Measured: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

  2. Mean change in percentage of total body surface area (%BSA) affected from Baseline to Week 8

    Assessment of %BSA is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (Head and neck = 10% [10 handprints], upper extremities = 20% [20 handprints], trunk (including axillae and groin) = 30% [30 handprints], lower extremities, including buttocks, = 40% [40 handprints]). Estimates of the percent involvement of each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.

    Measured: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

  3. Percentage of participants with ≥ 90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8

    Severity Index (EASI) score from Baseline to Week 8 Description: The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.

    Measured: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

  4. Number of participants with one or more Treatment Emergent Adverse Events (TEAEs)

    TEAEs are AEs that started on or after the first dose of study medication.

    Measured: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks

  5. Number of participants with one or more Treatment Emergent Adverse Events (TEAEs)

    TEAEs are AEs that started on or after the first dose of study medication.

    Measured: Baseline to the end of the Open-Label Period, up to 56 weeks

  6. Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs)

    TEAEs are AEs that started on or after the first dose of study medication.

    Measured: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks .

  7. Percentage of participants with one or more Treatment Emergent Adverse Events (TEAEs)

    TEAEs are AEs that started on or after the first dose of study medication.

    Measured: Baseline to the end of the Open-Label Period, up to 56 weeks.

  8. Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall)

    The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

    Measured: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks

  9. Investigator-assessed Local Tolerability Scale (LTS) scores by visit (overall)

    The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

    Measured: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.

  10. Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas)

    The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

    Measured: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks

  11. Investigator-assessed Local Tolerability Scale (LTS) scores by visit (sensitive areas)

    The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

    Measured: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2025
  2. Study start29 Dec 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Why it stopped: As a precaution, study drug dosing is paused due to a PK finding in OG505-3104. No safety signal or change to the established safety or benefit-risk profile has been identified. The Sponsor is further investigating and assessing the data.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Following a screening period of up to 30 days, eligible participants will be randomly assigned to one of two groups for up to 8 weeks. During this time-called the Double-Blind Period-2 out of 3 participants will receive the active treatment (tapinarof cream, 1%), while 1 out of 3 will receive a vehicle cream (placebo). Following completion of the Double-blind period, participants will enter the 48-week Open Label Period and will be treated as needed.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07265479
Sponsor's protocol ID
OG0505-3104
Acronym
Adoring
Status last verified
Aug 2026
First submitted
21 Nov 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tapinarof cream, 1% in people with Atopic Dermatitis, run by Organon and Co at 46 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8 (time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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