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Vtama

Also known as tapinarof

TypeTopical StageApproved Latest updateDec 29, 2025Phase 3 study started
Picture from the US label: NDC 81672-5051-1 Rx only VTAMA ® (tapinarof) cream 1% For topical use only. 60g
From the labelA picture from the US label, as DailyMed publishes it.

What stands out

  • Activates AhR, a sensor inside cells that responds to chemical signals and changes gene activity
Derived from US label · UniProt P35869 · This is a summary of public records for informational purposes only. It is not medical advice.

Results

Trial: NCT05014568
Clear or almost clear skinAfter 8 weeks
Vehicle Cream137 people
14 in 100
Tapinarof Cream270 people
45 in 100
03060

As the trial posted it: Risk Ratio, log 2.60, 95% CI 1.66 to 4.09, p <0.0001, cochran-mantel-haenszel.

Eczema score (EASI) at least 75% betterAfter 8 weeks
Vehicle Cream137 people
23 in 100
Tapinarof Cream270 people
56 in 100
03060

As the trial posted it: Risk Ratio, log 2.17, 95% CI 1.57 to 3.00, p <0.0001, cochran-mantel-haenszel.

Eczema score (EASI) at least 90% betterAfter 8 weeks
Vehicle Cream137 people
6 in 100
Tapinarof Cream270 people
30 in 100
02040

As the trial posted it: Risk Ratio, log 3.74, 95% CI 1.98 to 7.09, p <0.0001, cochran-mantel-haenszel.

NCT05014568 · Ages 2+ · Results posted Sep 2025 · This is a summary of trial data for informational purposes only. It is not medical advice.
Trial: NCT05014568
Itch score at least 4 points betterAfter 8 weeks
Vehicle Cream54 people
34 in 100
Tapinarof Cream103 people
56 in 100
03060

As the trial posted it: Risk Ratio, log 1.54, 95% CI 1.03 to 2.31, p = 0.0366, cochran-mantel-haenszel.

NCT05014568 · Ages 2+ · Results posted Sep 2025 · This is a summary of trial data for informational purposes only. It is not medical advice.
What is IGA?
  • IGA stands for Investigator Global Assessment.
  • 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 calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4).As this trial registered it · NCT05014568 (the full definition is there)
What is EASI?
  • EASI stands for Eczema Area and Severity Index.
  • The Eczema Area and Severity Index (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.As this trial registered it · NCT05014568 (the full definition is there)
What is the itch score?
  • NRS stands for Numeric Rating Scale.
  • The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to quickly assess itch/pruritus severity over a 24-hour period. The PP-NRS is scored on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". The subject will utilize the scale to assess peak pruritis once per day and record the results in their diaries. The daily ratings are averaged to generate a score for the week.As this trial registered it · NCT05014568 (the full definition is there)
Why this trial?

Of Vtama’s 4 trials with posted results, NCT05014568 is shown first: of the trials that compared the drug with placebo on a result this page charts, it had the most US sites (60). NCT05032859, a matching trial the sponsor ran alongside it, is in the list below. We rank those trials by whether they set out to measure skin clearing, whether they tested the drug on its own, their phase, whether they were randomised, whether they included adults, whether they ran in the US, how many doses they tested, how many US sites they had, their size, and then how recently they finished.

All 4 Vtama trials
PostedTrialPhaseAgesPeople
Sep 2025NCT05186805Phase 22–1736
Sep 2025NCT05014568 Shown abovePhase 32+407
Sep 2025NCT05032859Phase 32+406
Aug 2025NCT05142774Phase 32+728

Side effects

In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.

FDA label dated May 28, 2025

History

Earliest recorded event: Sep 1, 2021. This timeline shows events collected by Eczema Radar and may not include the treatment’s full history. Study details reflect the latest registry record available here.

Sources

From the FDA
Trials
For patients