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Topical Treatment

TDM-180935 for Eczema

Phase 2
Recruiting
Research Sponsored by Technoderma Medicines Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

This trial is comparing the effectiveness of TDM-180935 in patients with atopic dermatitis by randomly assigning them to different groups and using a control group for comparison.

Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing TDM-180935 ointment in two different strengths (2.0% and 1.0%) against placebo ointments (vehicles) that look the same but don't contain the active drug. Participants will be randomly assigned to one of these groups.See study design
What are the potential side effects?
Potential side effects aren't listed, but topical treatments for atopic dermatitis may include skin irritation, burning or itching at the application site, dryness, redness, or peeling.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in BSA (body surface area) affected
Change in m-EASI (modified Eczema Area and Severity Index) score
Proportion of patients with a 4-point improvement from Baseline in WI-NRS (Worst Itch-Numeric Rating Scale) score
+4 more
Other outcome measures
Changes from Baseline in vital signs (heart rate)
Changes from Baseline in vital signs (respiration rate)
Changes from Baseline in vital signs (systolic and diastolic blood pressure)
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: TDM-180935 topical ointment 2.0%Experimental Treatment1 Intervention
Daily dose of 2.0% of TDM-180935 topical ointment
Group II: TDM-180935 topical ointment 1.0%Experimental Treatment1 Intervention
Daily dose of 1.0% of TDM-180935 topical ointment
Group III: TDM-180935 topical vehicle ointment 1Placebo Group1 Intervention
Daily dose of placebo color matched to TDM-180935 topical ointment 1.0%
Group IV: TDM-180935 topical vehicle ointment 2Placebo Group1 Intervention
Daily dose of placebo color matched to TDM-180935 topical ointment 2.0%

Find a Location

Who is running the clinical trial?

Therapeutics, Inc.Industry Sponsor
30 Previous Clinical Trials
3,888 Total Patients Enrolled
Technoderma Medicines Inc.Lead Sponsor
4 Previous Clinical Trials
191 Total Patients Enrolled
Daniel J. Piacquadio, M.D.Study DirectorTherapeutics Incorporated
2 Previous Clinical Trials
129 Total Patients Enrolled
~10 spots leftby Sep 2024