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Tests treatment safety and results for Atopic Dermatitis
Official title A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
ClinicalTrials.gov ID: NCT07265479
What this study is testing
What is Tapinarof cream, 1%?
Tapinarof cream, 1% is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for atopic dermatitis.
Also referred to as OG-0505, DMVT-505.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 23
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Bryant, Arkansas, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Thousand Oaks, California, United States
- Castle Rock, Colorado, United States
- Boca Raton, Florida, United States
- Jacksonville, Florida, United States
- Wellington, Florida, United States
- Cumming, Georgia, United States
- Meridian, Idaho, United States
- Skokie, Illinois, United States
- Indianapolis, Indiana, United States
- Plainfield, Indiana, United States
- Bowling Green, Kentucky, United States
- Rockville, Maryland, United States
- Auburn Hills, Michigan, United States
- New Brighton, Minnesota, United States
- Ridgeland, Mississippi, United States
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 23 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Bryant, Arkansas, United States; Los Angeles, California, United States; Sacramento, California, United States; San Diego, California, United States; Thousand Oaks, California, United States and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.