TDM-180935 for Eczema
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new ointment, TDM-180935, to determine its effectiveness for people with eczema (atopic dermatitis). Eczema causes patches of skin to become inflamed, itchy, cracked, and rough. The trial includes different groups: some will use the TDM-180935 ointment, while others will use a placebo (a harmless substance resembling the ointment but without active ingredients) for comparison. Suitable participants have had mild to moderate eczema for at least two years, with symptoms affecting specific skin areas. Participants must apply the treatment daily and follow study instructions, including avoiding direct sunlight on treated areas. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important advancements in eczema care.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop using certain medications before starting. You must not use topical products on the treatment area for 2 weeks and systemic treatments for eczema for 4 weeks before the trial. If you are in the PK Cohort, you must also stop using systemic prescription medications 14 days before and OTC medications 7 days before the trial.
Is there any evidence suggesting that TDM-180935 is likely to be safe for humans?
Why do researchers think this study treatment might be promising for eczema?
Unlike the standard eczema treatments, which typically include corticosteroids and topical calcineurin inhibitors, TDM-180935 offers a novel approach. This treatment is a topical ointment with a new active ingredient that targets eczema differently. Researchers are excited because it could offer an alternative for patients who don't respond well to current therapies. Moreover, the ointment comes in two strengths, providing flexibility in managing different severities of eczema. The potential for fewer side effects compared to steroids also adds to the excitement surrounding this investigational treatment.
What evidence suggests that TDM-180935 could be an effective treatment for eczema?
Research has shown that TDM-180935, a skin cream, yields promising results for treating atopic dermatitis, a common form of eczema. In an earlier study, 62.5% of patients using the 2% cream experienced significant improvement by week 8. This trial will test two concentrations of TDM-180935: a 1.0% ointment and a 2.0% ointment. The treatment works by blocking certain proteins that cause inflammation, reducing eczema flare-ups. The cream is also safe, with minimal absorption into the bloodstream. These findings suggest TDM-180935 could be an effective option for people with atopic dermatitis.12367
Who Is on the Research Team?
Daniel J. Piacquadio, M.D.
Principal Investigator
Therapeutics Incorporated
Are You a Good Fit for This Trial?
This trial is for individuals with atopic dermatitis, also known as eczema. Specific details about who can join are not provided, but typically participants must have a confirmed diagnosis and meet certain health criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized into different groups and treated with TDM-180935 or placebo for 8 weeks
Pharmacokinetics
Eligible subjects in the PK cohort are treated with the high dose in an open label fashion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TDM-180935
Find a Clinic Near You
Who Is Running the Clinical Trial?
Technoderma Medicines Inc.
Lead Sponsor
Therapeutics, Inc.
Industry Sponsor