Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07265479

A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

3 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dermatology Research Institute, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

tapinarof cream, 1%

Drug

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.

Other names: OG-0505, DMVT-505, GSK2894512A, GSK28994512, STI-1001, WBI-1001

Vehicle cream

Drug

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

Primary outcomes

  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

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

    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.

  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

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Lead Late-Stage Clinical Development

CONTACT

[email protected]

551-430-6000

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Acronym: Adoring

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 4, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.