Study Summary
This trial is testing a topical ointment for the treatment of chronic idiopathic urticaria (CIU). The trial is designed to test the safety and efficacy of the ointment, and will enroll subjects with either the RXLI or ARCI subtypes of CIU. The trial will be conducted in three periods: induction (3 weeks), treatment (9 weeks), and maintenance (12 weeks).
- Ichthyosis
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 12 weeks
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
3 Treatment Groups
TMB-001 0.05%
1 of 3
Maximal use
1 of 3
Vehicle
1 of 3
Experimental Treatment
Non-Treatment Group
142 Total Participants · 3 Treatment Groups
Primary Treatment: TMB-001 · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age Any Age · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| North Carolina | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Why did patients apply to this trial?
- "I need help managing my HS."
How many prior treatments have patients received?
| 3+ | 100.0% |
Frequently Asked Questions
How many people will be taking part in this study at the most?
"One hundred and forty-two individuals that fit the pre-stated inclusion criteria are required to enroll in this clinical trial. US Derm Partners in Phoenix, Arizona and Stanford Children's Health in Palo Alto, California are two of the medical sites where patients can participate in this study." - Anonymous Online Contributor
Are there any side effects to taking TMB-001?
"TMB-001 has been given a safety score of 3 by our team at Power. This is because it is a Phase 3 trial, which demonstrates some efficacy and multiple rounds of data supporting safety." - Anonymous Online Contributor
In how many places is this research being done?
"This clinical trial is being conducted at 18 different sites, including Stanford Children's Health in Palo Alto, Medical Dermatology Specialists (US Derm Partners) in Phoenix, and About Skin Dermatology in Centennial, among other locations." - Anonymous Online Contributor
Are there any unfilled positions in this experiment?
"The trial is definitely still recruiting patients if you refer to the information on clinicaltrials.gov. To be more specific, the trial was first posted on June 21st, 2022 and was edited more recently on July 6th, 2022. In total, the study needs 142 patients from 18 different locations." - Anonymous Online Contributor