A Phase 3 interventional study of Tapinarof cream, 1% and Vehicle Cream in Atopic Dermatitis, sponsored by Organon and Co. Suspended at 46 sites in 2 countries. Open to participants aged 3 Months to 23 Months. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
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.
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 187 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tapinarof cream, 1%, applied topically once daily
Drug: Tapinarof cream, 1%
Vehicle cream is applied topically once daily for up to 8-weeks.
Drug: Vehicle Cream
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.
Also known as: OG-0505, DMVT-505, GSK2894512A, GSK28994512, STI-1001, WBI-1001
Applied topically once daily to lesions on participant's skin during the Double-Blind period.
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.
Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
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.
Time frame: Baseline to the end of the Open-Label Period, up to 56 weeks.
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.
Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
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.
Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
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.
Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.
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.
Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks
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.
Time frame: Baseline to the end of the Open-Label Period, up to 56 weeks
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.
Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks .
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.
Time frame: Baseline to the end of the Open-Label Period, up to 56 weeks.
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.
Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks
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.
Time frame: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.
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.
Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks
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.
Time frame: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.
Plan to share: No
No publications or documents are linked to this record.
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.
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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is suspended, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Organon and Co