TDM-180935 for Eczema

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Technoderma Medicines Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?Randomized, Vehicle-controlled, Parallel Group Study of TDM-180935 in Atopic Dermatitis Patients

Eligibility Criteria

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

I have signed a consent form for the trial.

I agree to use a simple moisturizer as instructed for the study period.

My kidney and liver functions are normal according to my recent tests.

+9 more

Exclusion Criteria

Patient has a history of alcohol abuse according to medical history within 6 months prior to Visit 1/Screening

Patient has any condition, which, in the investigator's opinion, would make it unsafe for the patient to participate in this study, including clinically significant abnormal laboratory, or 12-lead electrocardiogram (ECG) findings during the screening period or Visit 2/Baseline prior to dosing of the IP

Patient is currently enrolled in an investigational drug, biologic, or device study

+21 more

Participant Groups

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.

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%