In short
Iodine is a chemical element and an essential mineral nutrient for the human body. It is being studied in a completed Phase 1/2 clinical trial as a topical formulation for atopic dermatitis (eczema). The trial enrolled 27 patients to assess the safety and local tolerability of a new iodine formulation called DLQ03.
Iodine is a chemical element that the body needs as an essential mineral nutrient. It is best known for its role in thyroid function, but it is also being investigated in other areas. One completed clinical trial has studied a new topical iodine formulation called DLQ03 in patients with atopic dermatitis, a common form of eczema.
Key points
- Iodine is an essential mineral nutrient required for metabolism and brain development.
- One completed Phase 1/2 trial tested a topical iodine formulation (DLQ03) in atopic dermatitis.
- The trial enrolled 27 participants and focused on safety and local tolerability.
- The studied formulation was applied as a topical use medicine.
- The primary goal was to measure treatment-emergent adverse events and local irritation.
- Iodine is already authorised as a medicine in some records, but this specific formulation was investigational.
What is iodine?
Iodine is a mineral nutrient essential for the regulation of key physiological functions, including metabolism and brain development and function in children and adults. It is a chemical element, meaning it is a chemically synthesised substance in the context of pharmaceutical use. In the registry records for the clinical trial, the substance appears under the name IODINE and is already authorised as a medicine in some jurisdictions, though the specific DLQ03 formulation was investigational.
How does iodine work?
Iodine works in the body primarily through the thyroid hormones. It is required for growth and brain development, and adequate iodine intake is especially important before and during pregnancy. As a mineral nutrient, iodine is not a targeted drug in the way a modern pharmaceutical often is; instead, it is a building block the body uses to make essential hormones. The clinical trial of DLQ03 did not investigate this systemic mechanism, but rather the local tolerability of a topical formulation on affected skin.
Which conditions is iodine used or studied for?
- Atopic dermatitis (eczema) — the completed Phase 1/2 trial tested a topical iodine formulation in patients with this inflammatory skin condition.
- Iodine deficiency — as a nutrient, iodine is important for preventing deficiency, which can affect metabolism and brain development.
- Thyroid-related needs — iodine is required for the production of thyroid hormones, which regulate growth and metabolism.
How is iodine given?
In the clinical trial, iodine was given as a topical use medicine, meaning it was applied to the skin. The intervention was a 1 mg dose of iodine formulated for topical use. Iodine is also commonly known as a nutrient taken in through food, with main dietary sources including fish, eggs, and dairy products.
What do the clinical trials show?
There is one registered clinical trial of the DLQ03 iodine formulation. It was a Phase 1/2 interventional study that has been completed.
Who could take part in the trial?
The trial enrolled 27 participants with atopic dermatitis. The study was designed to assess safety and local tolerability in this patient group.
What was measured in the trial?
The primary outcomes focused on safety: treatment-emergent adverse events and serious adverse events, concomitant medication use, vital signs including pulse rate and blood pressure, clinical laboratory tests, ECG parameters, and a local irritation grading scale. This means the study was primarily looking at whether the topical formulation caused any harmful effects or skin irritation, rather than measuring how well it treated the eczema.
What side effects are known?
The supplementary sources provided do not describe specific side effects of topical iodine formulations. The clinical trial was designed to detect treatment-emergent adverse events and local irritation, but the results of those measurements are not included in the registry record.