A clinical study confirms the positive effect of vitamin D ointment on wound healing and itch in RDEB

New scientific publication from the Pinon/Gruber working group

A main focus in EB research deals with the treatment of non-healing wounds. Their susceptibility to colonisation by microorganisms such as bacteria and viruses might contribute to the delayed wound healing and development of life-threatening skin tumors. The hormone vitamin D3 (VD3) has been shown to have a positive impact on wound healing by promoting the production of antimicrobial peptides (AMP) in skin cells. AMP protect the body from microorganisms by forming a chemical shield on the skin's surface.
Researchers at the EB House have shown in previous studies that VD3 can increase the AMP level in EB skin cells and thus improve wound healing and antimicrobial effects. A first application of a low-dose VD3 ointment onto a chronic wound in a DEB patient resulted in faster wound closure, as well as a reduction in itch and pain.
A recent clinical study evaluated the safety and efficacy of the VD3 ointment compared to a placebo ointment in six RDEB patients. Two non-healing wounds per participant were treated by daily application of VD3 or placebo ointment for 4 weeks. After a 2-months wash-out phase, the treatment was crossed over, meaning that a patient who received placebo in the first phase was treated with the VD3 ointment in the second phase and vice versa. The clinical trial was designed as a double-blind study, in which neither the doctors nor the patients know when which treatment was applied. This should help to prevent that any bias or expectations will influence the results.
The VD3 treatment led to a significant reduction in wound size at day 14 compared to the placebo ointment. Also, a striking effect of VD3 over placebo was the reduction of itch. An effect for pain reduction through VD3 remains inconclusive, since patients reported a benefit with both treatments. The results are very encouraging, but further studies with a larger number of participants are needed to underpin the therapeutic effect and determine optimal VD3 concentrations and formulations.
In the meantime, based on the available results, the tested VD3 ointment can be used as a safe option for local wound care in DEB patients at the doctor's discretion and under supervision.
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