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Topical Treatment

TDM-180935 topical ointment 2.0% for Atopic Dermatitis

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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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 2Placebo Group1 Intervention

Daily dose of placebo color matched to TDM-180935 topical ointment 2.0%

Group IV: TDM-180935 topical vehicle ointment 1Placebo Group1 Intervention

Daily dose of placebo color matched to TDM-180935 topical ointment 1.0%

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Technoderma Medicines Inc.Lead Sponsor

4 Previous Clinical Trials

191 Total Patients Enrolled

Therapeutics, Inc.Industry Sponsor

30 Previous Clinical Trials

3,888 Total Patients Enrolled

Daniel J. Piacquadio, M.D.Study DirectorTherapeutics Incorporated

2 Previous Clinical Trials

129 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many healthcare facilities is this clinical study currently being conducted?

"Currently, this clinical study is operational at 7 sites in various cities such as Norfolk, Anderson, and Austin among others. Opting for a site close to your residence can help reduce travel commitments throughout the trial duration."

Answered by AI

Are potential participants currently being accepted for this ongoing medical study?

"As per clinicaltrials.gov, the recruitment for this trial is presently closed. The initial posting of this trial was on April 15th, 2024, and the latest update occurred on April 9th, 2024. Despite its closure to new participants, there are currently active enrollment opportunities in 245 alternative trials."

Answered by AI

Has the topical cream TDM-180935 at a concentration of 1.0% been officially sanctioned by the FDA?

"Based on our evaluation, the safety rating of TDM-180935 topical ointment 1.0% is a 2 according to Power's assessment criteria for Phase 2 trials. At this stage, there exists some evidence supporting its safety profile, although efficacy data is lacking."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of TDM-180935 in Atopic Dermatitis Patients

2024. "Study of TDM-180935 in Atopic Dermatitis Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06363461.

All > Atopic Dermatitis