An open-label, phase II proof-of-concept study to evaluate the clinical efficacy and safety of tapinarof for adult patients with palmoplantar keratoderma
D
David Rosmarin
Primary Investigator
Recruiting
18-75 years
All
Phase
2
6 participants needed
1 Location
Brief description of study
What is the purpose of this study?
This study is being done to find out how safe and how well the drug Tapinarof (VTAMA) works for stopping or treating palmoplantar keratoderma, which is a condition characterized by thickened skin on your palms and soles. Tapinarof, used as a topical 1% cream, is a naturally occuring compound used for the treatment of psoriasis. While Tapinarof has been cleared by the FDA for treating psoriasis exclusively, its potential use for palmoplantar keratoderma still needs to be explored. Your participation in this study will contribute to providing valuable information that may lead to potential approval for palmoplantar keratoderma in the future.
Who can take part?
Anyone ages 18 and older who has palmoplantar keratoderma.
Additional information
The study is being conducted by Dr. David Rosmarin at the Indiana University School of Medicine, Department of Dermatology.. It is funded by Dermavant Sciences, who is also the manufacturer of the drug.
Detailed description of study
What will happen during the study?
Your participation will consist of applying the drug Tapinarof (topical cream) every day for 16 weeks to see if the condition is improving. During the study, you will be asked to come in for a check-up every 4-8 weeks. At these visits, the doctor will assess and take pictures of the affected areas, complete questionnaires, and monitor for any side effects.
There will be 7 study visits in total:
- 1 screening and baseline visit
- 5 visits during the treatment period, typically every 4- 8 weeks apart
- 1 safety follow-up visit
If you meet the study requirements and take part in it, you will be in this study for about 52 weeks (1 year). This includes:
- A screening and baseline visit on the 1st visit which establishes eligibility and pre- treatment assessments.
- A treatment period of 16 weeks (continuous treatment period) that can last up to 36 weeks (extension treatment period)
- Continuous treatment period: all patients will be treated up until this phase continuously. The patients who have improved with no signs and symptoms of the condition can stop at 16 weeks or can opt to stay on the drug till the end of the study.
- Extension treatment period: Patients that still have the disease even after 16 weeks will continue the treatment till the condition there are no signs and symptoms of the condition or till the end of the study period.
- A safety follow-up visit that occurs approximately on week 52 to monitor the drug response
Incentive/compensation
You will receive a total of $320.00 payment for taking part in this study. You will receive $40.00 after each completed visit, for a total of 7 visits throughout the study. Any of the 7 visits that are missed will not be compensated. If necessary or required for you to come in for any unscheduled visits, you will receive $40.00 for that visit.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Palmoplantar keratoderma
-
Age: Between 18 Years - 75 Years
-
Gender: All
Inclusion criteria
- Diagnosis of palmoplantar keratoderma
- Not currently being treated or your current treatment has failed
- In generally good health (aside from your keratoderma)
- If female, must no be pregnant
Updated on
11 Sep 2024.
Study ID: DERM-IIR-DERMAVANT, 21197
Find a site
,
You have contacted , on
Your message has been sent to the study team at ,
A copy of the message has been sent to your email
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
