CLINICAL TRIAL

Optical Coherence Tomography for Dermatitis

Recruiting · 18+ · All Sexes · New York, NY

Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

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About the trial for Dermatitis

Eligible Conditions
Dermatitis · Dermatitis, Atopic · Dermatitis, Dermatitis Atopic · Eczema

Treatment Groups

This trial involves 2 different treatments. Optical Coherence Tomography is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Optical Coherence Tomography
DEVICE
Dupilumab
DRUG
Reflectance confocal microscopy
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Optical Coherence Tomography
2016
Completed Phase 2
~1420
Dupilumab
2017
Completed Phase 3
~9410
Reflectance confocal microscopy
2008
N/A
~830

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have a score of 3 or more on the IGA scale of 0-4 at baseline. show original
Eczema Area and Severity Index (EASI) score of ≥16 at baseline
You are at least 18 years old. show original
You have atopic dermatitis (AD) affecting ≥10% BSA at baseline. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to 16 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to 16 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to 16 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Optical Coherence Tomography will improve 4 primary outcomes in patients with Dermatitis. Measurement will happen over the course of Baseline to 16 weeks.

Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT)
BASELINE TO 16 WEEKS
Optical Coherence Tomography (OCT) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. OCT can detect deep structures in the skin, identify areas of inflammation, and determine the thickness of the skin. These measures will be consolidated to a severity score ranging 0-3, (0= no disease, 3= severe disease) and will be tracked throughout the duration of the study. The following features will be aggregated to form an Optical Coherence Tomography-severity-score: Change in the epidermal thickness Changes in anatomy or appearance of the dermo-epidermal junction and the dermis. Changes in vascular flow patterns, including the number and density of vessels in skin using the dynamic feature of Optical Coherence Tomography Grading will be scored 0=none, 1=mild, 2= moderate, 3=severe
BASELINE TO 16 WEEKS
Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM)
BASELINE TO 16 WEEKS
Reflectance Confocal Microscopy (RCM) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. RCM can visualize cells with a resolution comparable to a light microscope, allowing the investigators to identify the degree of inflammation and damage to the skin. An overall disease severity score ranging from 0-3 (0=none, 1=mild, 2= moderate, 3=severe) will use aggregates of the following *features: Spongiosis Parakeratosis Epidermal thickness Quality of honeycomb structure of the stratum spinosum Appearance of the dermal-epidermal junction Appearance of the superficial dermis Recognition of the dermal papilla Caliber of blood vessels Presence of inflammatory cells Grading will be scored (0=none, 1=mild, 2= moderate, 3=severe), a greater numerical score indicates more advanced disease.
BASELINE TO 16 WEEKS
Eczema Area and Severity Index (EASI)
BASELINE TO 16 WEEKS
The Eczema Area and Severity Index (EASI) is a tool used to measure the extent (area) and severity of atopic eczema, ranging 0-72, 0 being least severe and 72 being most severe.
BASELINE TO 16 WEEKS
Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD)
BASELINE TO 16 WEEKS
Investigator will use the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) a tool used to measure the severity of atopic eczema, ranging 0-4, 0 is clear and 4 is most severe.
BASELINE TO 16 WEEKS

Who is running the study

Principal Investigator
O. M.
Orit Markowitz, MD
OptiSkin Medical

Patient Q & A Section

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

Can dermatitis be cured?

Dermatitis has not been shown to be curable, and therefore any approach that would attempt to cure dermatitis would likely be very risky. Data from a recent study presented here suggest that, like asthma, dermatitis may be a better concept to control than cure.

Anonymous Patient Answer

What causes dermatitis?

This summary should help anyone who seeks information about the factors that contribute to dermatitis. This should make people think about their routine activity and their surroundings.

Anonymous Patient Answer

How many people get dermatitis a year in the United States?

About 400,000 to 700,000 cases of dermatitis are diagnosed each year in the United States. The most frequent conditions among all cases diagnosed were perinatal conditions and inflammatory conditions of skin. Dermacentopathism should be considered when determining a patient's risk of developing skin diseases; skin diseases should also be considered when determining risk for specific immune-mediated illnesses.

Anonymous Patient Answer

What are the signs of dermatitis?

Some symptoms last for less than 2 weeks, and the signs may manifest as a rash with or without fever, skin cracking/popping or irritation, hives, blisters, or blisters with a small pool of clear fluid. Skin discolouring can also occur and is more common in some ethnic groups. Severe itching may occur, especially while sleeping. Symptoms last for over 8 weeks and include rashes, itching, hives, rash and hair loss.

Anonymous Patient Answer

What are common treatments for dermatitis?

There is a paucity of data on effective treatments for dermatitis. There is wide variation in the quality of reporting in the published literature. Patient expectations of treatment are based on a combination of anecdotal evidence and the information provided by drug companies. There is a challenge for the dermatology community to collect high quality evidence so that our patients can make good treatment decisions.

Anonymous Patient Answer

What is dermatitis?

While many dermatoses cause localized inflammation, skin lesions and conditions that may need medical attention. The severity will depend on the nature of the skin lesion, duration, severity of itching and the presence of secondary infections.\n

Anonymous Patient Answer

Is reflectance confocal microscopy typically used in combination with any other treatments?

Reflectance confocal microscopy was found to be frequently used with other treatment modalities as part of routine care for psoriatic skin conditions. A majority of clinicians consider the RCM technique to be helpful in their management of psoriatic skin conditions.

Anonymous Patient Answer

Who should consider clinical trials for dermatitis?

Physicians may wish to evaluate patient preferences (as well as the benefit, risks, and cost) of a treatment before considering participating in a clinical trial.

Anonymous Patient Answer

What are the latest developments in reflectance confocal microscopy for therapeutic use?

In a recent study, findings from this pilot study demonstrate that RCM using the DiM-1 and DiM-4 fluorophore systems is safe. The DiM-1 system was better suited for clinical use, compared with the DiM-4 system.

Anonymous Patient Answer

Does dermatitis run in families?

The findings provide a plausible explanation for the high incidence of allergic disorders and are consistent with the hypothesis that dermatitis may have a genetic component.

Anonymous Patient Answer

What is the average age someone gets dermatitis?

Dermatitis can occur at any age, and the condition may affect both men and women. The typical age at presentation of the condition is around 21 years of age.

Anonymous Patient Answer

What is the latest research for dermatitis?

There are many skin diseases you could be diagnosed with, including contact dermatitis or skin cancer, so seek a dermatologist. You can find a list of doctors with a special interest in dermatology at [WorldHealthOrganizations/Global Alliance for Health Organizations.org.].

Anonymous Patient Answer
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