{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T08:57:14Z","timestamp":1790845034422,"version":"4.1.0"},"reference-count":0,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Laboratory and animal work was followed by a dose-finding study and a randomised, placebo-controlled, double-blind clinical trial (allocation 1:1:1:1).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>A single-centre study conducted in London, UK, with dosing over winter months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>108 healthy volunteers between 18 and 65 years of age with suspected low vitamin D levels.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Cholecalciferol phosphate patch<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>Safety: blood calcium levels. Efficacy: Percentage change in the concentration of serum 25(OH)D3 compared to baseline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In animals and ex vivo human skin, cholecalciferol phosphate penetrates the tissue and converts to cholecalciferol (vitamin D3). Biological responses mimic ultraviolet radiation (UVR) skin exposure, upregulating the vitamin D-binding protein (VDBP) in rodents and improving systemic vitamin D status without associated skin inflammation or DNA damage. In Part 1 of the clinical study, lasting 4 weeks, 16 participants were enrolled in two dose-escalating cohorts (total doses of 5 mg and 31 mg). Across both cohorts, two participants reported local skin irritation, but serum calcium and 25(OH)D3 did not change. A total of 92 participants were randomised in Part 2, lasting eight weeks; 30 were allocated to active arm A and 29 to placebo, and both arms continued to 8 weeks, whilst two arms, active B and active C, were stopped after 4 weeks. Seventy-three participants completed their final study visit and 19 discontinued. Comparing active arm A (total dose = 140 mg) with placebo, the per-protocol percentage change from baseline in 25(OH) D3 was +19.9 percentage points (95% CI \u22121.3 to +41.0; p = 0.065). In the modified intention-to-treat population (n = 54), the baseline adjusted difference in serum 25(OH)D3 at 8 weeks was +0.52 ng\/mL (95% CI \u22122.18 to +3.22; p = 0.71). Adverse skin irritation events were reported by 42.9% of active and 42.3% of placebo participants (p = 1.00).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>A cholecalciferol phosphate patch generated vitamin D in the skin in animals without UV exposure. In humans, the patch was safe but did not improve vitamin D status; the benefit was not greater than approximately 3 ng\/mL (300\u2013500 IU\/day of oral cholecalciferol).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov NCT 06098846<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/bjd\/ljag421","type":"journal-article","created":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T12:03:13Z","timestamp":1790769793000},"source":"Crossref","is-referenced-by-count":0,"title":["A UV-Free Strategy for Vitamin D Synthesis in Skin: Concept Verification and a Randomised Double-Blind Placebo-Controlled Clinical Trial of a Cholecalciferol Phosphate Patch (TransVitD)"],"prefix":"10.1093","author":[{"given":"Makiko","family":"Kawashita","sequence":"first","affiliation":[{"name":"1Centre for Pharmaceutical Medicine Research, Institute of Pharmaceutical Science, Franklin-Wilkins Building, King's College London, Faculty of Life Sciences & Medicine , London ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chui Hua","family":"Lim","sequence":"additional","affiliation":[{"name":"1Centre for Pharmaceutical Medicine Research, Institute of Pharmaceutical Science, Franklin-Wilkins Building, King's College London, Faculty of Life Sciences & Medicine , London ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Hibbard","sequence":"additional","affiliation":[{"name":"1Centre for Pharmaceutical Medicine Research, Institute of Pharmaceutical Science, Franklin-Wilkins Building, King's College London, Faculty of Life Sciences & Medicine , London ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Andriollo","sequence":"additional","affiliation":[{"name":"1Centre for Pharmaceutical Medicine Research, Institute of Pharmaceutical Science, Franklin-Wilkins Building, King's College London, Faculty of Life Sciences & Medicine , London ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanxiang","family":"Li","sequence":"additional","affiliation":[{"name":"1Centre for Pharmaceutical Medicine Research, Institute of Pharmaceutical Science, Franklin-Wilkins Building, King's College London, Faculty of Life Sciences & Medicine , London ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0124-961X","authenticated-orcid":false,"given":"Karl P","family":"Lawrence","sequence":"additional","affiliation":[{"name":"1Centre for Pharmaceutical Medicine Research, Institute of Pharmaceutical Science, Franklin-Wilkins Building, King's College London, Faculty of Life Sciences & Medicine , London 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