The British journal of dermatology · 2026
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).
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Kawashita Makiko, Lim Chui Hua, Hibbard Thomas, Andriollo Paolo, Li Yanxiang, Lawrence Karl P, John Ellen, Royall Paul R, Guo Qing, Tasdemir Didar, Ayrton Oscar, Fitzgerald O'Connor Edmund, Benaouda Faiza, Bashir Shazia, Cilibrizzi Agostino, Luebcke Peter, Young Antony R, Douiri Abdel, O'Shaughnessy Ryan, Carpenter Guy, Alhnan Mohamed, Jones Stuart A
Аннотация
DESIGN: 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).
SETTING: A single-centre study conducted in London, UK, with dosing over winter months.
PARTICIPANTS: 108 healthy volunteers between 18 and 65 years of age with suspected low vitamin D levels.
INTERVENTION: Cholecalciferol phosphate patch.
MAIN OUTCOME MEASURES: Safety: blood calcium levels. Efficacy: Percentage change in the concentration of serum 25(OH)D3 compared to baseline.
RESULTS: 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 -1.3 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 -2.18 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).
CONCLUSION: 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 (300-500 IU/day of oral cholecalciferol).
TRIAL REGISTRATION: ClinicalTrials.gov NCT06098846.
SETTING: A single-centre study conducted in London, UK, with dosing over winter months.
PARTICIPANTS: 108 healthy volunteers between 18 and 65 years of age with suspected low vitamin D levels.
INTERVENTION: Cholecalciferol phosphate patch.
MAIN OUTCOME MEASURES: Safety: blood calcium levels. Efficacy: Percentage change in the concentration of serum 25(OH)D3 compared to baseline.
RESULTS: 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 -1.3 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 -2.18 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).
CONCLUSION: 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 (300-500 IU/day of oral cholecalciferol).
TRIAL REGISTRATION: ClinicalTrials.gov NCT06098846.