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Safety and Tolerability of Topical Iodine (DLQ03) in Patients with Mild to Moderate Atopic Dermatitis Colonized with Staphylococcus aureus

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Atopic dermatitis (eczema) is a long‑lasting skin condition that causes itchy, red, and inflamed patches. The study examines a new skin ointment that contains iodine and is identified by the code name DLQ03. Participants will receive either the DLQ03 ointment or a placebo (an inactive substance) applied to a small, controlled skin wound. The purpose of the study is to assess safety and local tolerability of the test product in people with mild to moderate atopic dermatitis who have Staphylococcus aureus on their skin.

In this early‑stage trial, volunteers are randomly placed into one of the two groups, and the staff who evaluate the results do not know which treatment each person received (blind assessment). Over several weeks, participants come to the clinic for visits where the ointment is applied, basic checks such as pulse and blood pressure are taken, and simple lab tests are performed to look for any side effects. The wound area is inspected regularly for irritation, and overall health is monitored throughout the study period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessment
After agreeing to participate, you will sign an informed consent form.
Study staff will collect basic health information and perform initial measurements such as pulse, blood pressure, and a brief skin examination.
Step 2
Randomization to study medication
You will be assigned, by chance, to receive either the iodine formulation (the test product) or a placebo called perfluorohexyloctane.
The assignment is done without knowledge of the study staff who assess outcomes, to keep the evaluation unbiased.
Step 3
Receipt of study medication
If assigned to the test group, you will receive a topical preparation containing iodine at a dose of 1 mg per application.
If assigned to the placebo group, you will receive a topical preparation of perfluorohexyloctane, which contains no active substance.
Step 4
Application of medication
You will apply the medication to the designated wound area on the skin as instructed by the study staff.
The application is performed on the skin (topical use) and the frequency and duration of use will be explained by the study team.
Step 5
Regular study visits
You will attend scheduled visits throughout the trial period.
At each visit, the study team will check for any treatment‑emergent adverse events (new or worsening symptoms).
You will be asked to list any other medicines you are taking (concomitant medication).
Vital signs will be measured, including pulse rate (beats per minute) and both systolic and diastolic blood pressure (mmHg).
Blood and urine samples will be taken for routine laboratory tests (blood counts, chemistry, and urinalysis).
An electrocardiogram (ECG) will be performed to record heart activity, including heart rate and intervals such as PR, QRS, QT, QTcB, and QTcF.
A skin irritation grading scale will be used to assess any local irritation at the application site.
Step 6
Continuation of medication use
You will continue to use the assigned medication according to the schedule provided until the end of the study period.
Any changes in how the medication is applied or missed doses should be reported at the next visit.
Step 7
Final assessment and study completion
At the last visit, all previously described assessments (adverse events, vital signs, laboratory tests, ECG, and skin irritation) will be repeated.
You will return any remaining medication and receive a summary of the study procedures you completed.

Who can join the trial?

7 criteria

Be a man or woman who is between 18 and 65 years old, inclusive.
Have atopic dermatitis (eczema) that is considered mild to moderate, which means a doctor’s rating called the Investigator Global Assessment (IGA) of 2 or 3.
Be generally healthy without any other serious or uncontrolled long‑term illness that could affect participation in the study.
Have a diagnosis of atopic dermatitis that meets the Hannifin criteria (a set of rules doctors use to confirm eczema).
Have at least one target lesion—an eczema spot covering at least 0.5% of body surface area (BSA) and not located on the face—for part A, or two such lesions for part B.
The skin lesion(s) must test positive for Staphylococcus aureus (a common bacteria) on two separate lab cultures taken during the screening period.
Be able to complete required health checks, including vital signs, a 12‑lead ECG (a heart rhythm test), blood tests for hematology (blood cells), blood chemistry, virology (virus checks), and a urinalysis (urine test).

Who cannot join the trial?

2 criteria

Having another serious or recurring skin condition that could affect the study results, as judged by the doctor conducting the trial.
Currently using any eczema medicines that are prohibited for this study and not having stopped them for the required washout periods before the first dose.

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Investigated drugs

IODINE
is a topical antiseptic that is applied directly to the skin. In this study it is used to treat the skin of participants with atopic dermatitis who have a bacterial colonization. The purpose of using iodine is to see how it affects the safety of the skin, how well it is tolerated, and whether it helps with wound healing in the affected areas.
DLQ03
is an experimental medication being tested for the first time in people with mild to moderate atopic dermatitis. It is applied to the skin and is intended to help the skin heal and reduce the symptoms of eczema. The trial is looking at whether DLQ03 is safe to use, how the skin reacts to it, and how it may improve the healing process compared with a placebo.

What is already known about the treatment

Perfluorohexyloctane
This is a clear, oily liquid that is applied to the skin as a topical vehicle, meaning it is used to carry other substances but has no active drug effect itself. It is currently listed in medical references only as an inert carrier and is not approved for treating any disease. Because it does not contain an active ingredient, it has no therapeutic indication and works simply by forming a thin, non‑reactive layer on the skin. It is classified as a perfluorocarbon solvent used mainly in research and as a placebo in skin studies.
IODINE
Iodine is applied to the skin in a topical form, typically as a liquid or ointment, at a dose of 1 mg per application. It is a well‑known antiseptic that has been used for many years to clean wounds and prevent infections, and it is also listed in medical literature for treating superficial skin conditions caused by bacteria. The substance works by releasing free iodine molecules that destroy the proteins of microbes, thereby killing them on contact. It belongs to the pharmacological class of antiseptic/disinfectant agents.

Investigated diseases

Atopic dermatitis - Atopic dermatitis is a long‑lasting skin condition that causes red, itchy patches that often appear on the face, arms, and legs. It usually begins in childhood but can develop at any age. The rash tends to flare up periodically, especially when the skin becomes dry or is exposed to irritants, allergens, or stress. Over time the affected skin may become thicker, scaly, or develop small cracks. The condition can spread to other areas of the body as it progresses.