NICEVIVA
MONOGRAPH SPEC LATEST 2026

Vitamin B5 (Pantothenic Acid)

VITAMINS · Evidence Monograph

Vitamin B5 (Pantothenic Acid) is an evidence-graded vitamins monograph evaluated across 51 peer-reviewed PubMed studies (2 meta-analyses, 4 systematic reviews, and 11 randomized controlled trials, encompassing n = 3,082 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for cellular coenzyme synthesis, metabolic methylation, and micronutrient homeostasis.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 51 Studies
Meta-Analyses · Reviews 2 Meta · 4 Systematic Reviews
Randomized Trials (RCT) 11 RCTs (7 Double-Blind)
Cumulative Participants n = 3,082
Reported Trial Dosages 1000 mg · 60 mg · 10 mg
Trial Duration Range 18 days · 14 days · 4 weeks
Reading Time ~26 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for cellular coenzyme synthesis, metabolic methylation, and micronutrient homeostasis (supported by 51 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (1000 mg · 60 mg · 10 mg) over a structured 18 days evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Bioactive Coenzyme or Standardized Vitamin Form
Prioritize bioactive coenzyme forms (such as methylated B-vitamins or cholecalciferol D3) matched to water- or fat-soluble absorption pathways.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Steady daytime energy and correction of subclinical deficiency markers over 4–8 weeks.
Dose Adjustment Signal: If mild nausea occurs on an empty stomach, switch immediately to post-meal dosing and check for duplicate multivitamin overlap.
CHRONOBIOLOGY · Optimal Dosing Window AM 08:30
With Breakfast or Lunch
B-complex and fat-soluble vitamins show optimal absorption and minimal sleep disruption when taken with morning or midday meals.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
inflammation (PubMed clinical endpoint)
cancer (PubMed clinical endpoint)
skin (PubMed clinical endpoint)
alopecia (PubMed clinical endpoint)
hair (PubMed clinical endpoint)
01

What Is Vitamin B5 (Pantothenic Acid) & Why Does Form Matter?

Vitamin B5 (Pantothenic Acid) is classified under VITAMINS and has been investigated across 51 peer-reviewed PubMed publications for its role in cellular coenzyme synthesis, metabolic methylation, and micronutrient homeostasis.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (1000 mg, 60 mg, 10 mg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Vitamin B5 (Pantothenic Acid) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (11 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Vitamin B5 (Pantothenic Acid) acts on pathways governing cellular coenzyme synthesis, metabolic methylation, and micronutrient homeostasis. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Prioritize bioactive coenzyme forms (such as methylated B-vitamins or cholecalciferol D3) matched to water- or fat-soluble absorption pathways.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Vitamin B5 (Pantothenic Acid) an overall evidence rating of GRADE High (4.0 / 4.0) based on 51 PubMed studies: 2 meta-analyses, 4 systematic reviews, and 11 randomized controlled trials (7 double-blind, n = 3,082 total participants).

Representative peer-reviewed findings include: • PMID:41090263 (2025) — "Revealing VNN1: An Emerging and Promising Target for Inflammation and Redox Balance." (CONCLUSIONS: VNN1 represents a promising therapeutic target for modulating oxidative stress and immunometabolism in various diseases.) • PMID:38904980 (2024) — "Vitamins B(9) and B(12) in children with attention deficit hyperactivity disorder (ADHD)." (Conclusion: The results of this systematic review showed that the level of vitamins B9 and B12 in children with ADHD was significantly lower than that in healthy children.) • PMID:38542319 (2024) — "Unmasking the Metabolite Signature of Bladder Cancer: A Systematic Review." (The data from these comparisons suggest that increased concentrations of L-isoleucine, L-carnitine, oleamide, palmitamide, arachidonic acid and glycoursodeoxycholic acid and decreased content of deoxycytidine, 5-aminolevulinic acid and pantothenic acid should be considered compon)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

341543610.19 (0.13–0.29)379609221.740.215OR (favours ← / →)
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Bioactive Coenzyme or Standardized Vitamin Form. Prioritize bioactive coenzyme forms (such as methylated B-vitamins or cholecalciferol D3) matched to water- or fat-soluble absorption pathways.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 1000 mg · 60 mg · 10 mg · 4 mg over 18 days · 14 days · 4 weeks · 2 weeks. Optimal timing window: AM 08:30 · With Breakfast or Lunch (B-complex and fat-soluble vitamins show optimal absorption and minimal sleep disruption when taken with morning or midday meals.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Steady daytime energy and correction of subclinical deficiency markers over 4–8 weeks.

Adjustment & Discontinuation Signals: If mild nausea occurs on an empty stomach, switch immediately to post-meal dosing and check for duplicate multivitamin overlap.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Vitamin B5 (Pantothenic Acid), but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (AM 08:30 · With Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (1000 mg · 60 mg · 10 mg) and re-evaluate efficacy after 18 days.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (51 Studies) · 20 Quantitative Analyses

01
CLINICAL STUDY Immunity, inflammation and disease (2025) PMID: 41090263 ↗
Revealing VNN1: An Emerging and Promising Target for Inflammation and Redox Balance.
Clinical Trial Synthesis 2025 Clinical Study published in Immunity, inflammation and disease. Key conclusion: CONCLUSIONS: VNN1 represents a promising therapeutic target for modulating oxidative stress and immunometabolism in various diseases.
View Original PubMed Abstract ↓

INTRODUCTION: The intricate balance between immunometabolic homeostasis and redox equilibrium is crucial for maintaining health, and its dysregulation is implicated in a wide spectrum of diseases. Vascular non-inflammatory molecule-1 (VNN1) is an emerging pantetheinase that sits at the crossroads of inflammation and metabolism, yet a comprehensive review that synthesizes its tissue- and disease-specific roles and systematically evaluates its potential as a therapeutic target remains lacking. METHODS: A systematic literature search was conducted to identify relevant domestic and international studies on VNN1. The search included databases such as PubMed using keywords related to VNN1's structure and function, the disease roles of its metabolites (pantothenic acid, cysteamine), or inhibitors efficacy. The selected studies were critically reviewed and summarized to extract key pathways, inhibitor profiles and molecular docking analyses synthesized. RESULTS: VNN1 hydrolyzes pantetheine to generate metabolites essential for CoA synthesis and glutathione redox balance. Its upregulation is closely associated with the pathogenesis of acute and chronic inflammatory diseases and certain cancers, often serving as a biomarker for disease severity. Inhibiting VNN1, either genetically or pharmacologically with compounds like RR6, OMP-7, or natural products such as oleuropein, demonstrates significant anti-inflammatory and antioxidant effects in preclinical models. CONCLUSIONS: VNN1 represents a promising therapeutic target for modulating oxidative stress and immunometabolism in various diseases. Future research should develop disease-specific inhibitors, clarify tissue-specific mechanisms, and conduct clinical trials for translation. © 2025 The Author(s). Immunity, Inflammation and Disease published by John Wiley & Sons Ltd.

02
CLINICAL STUDY International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition (2024) PMID: 38904980 ↗
Vitamins B(9) and B(12) in children with attention deficit hyperactivity disorder (ADHD).
Clinical Trial Synthesis 2024 Meta-Analysis published in International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition involving n = 982 participants (SMD -0.8). Key conclusion: Conclusion: The results of this systematic review showed that the level of vitamins B9 and B12 in children with ADHD was significantly lower than that in healthy children.
View Original PubMed Abstract ↓

Background: Attention deficit hyperactivity disorder (ADHD) is a common childhood neurodevelopmental disorder that begins before age 12. Given the role of B group vitamins in cell metabolism, synthesis of nucleotides, and neurotransmitters, the present study systematically investigated the plasma levels of vitamins B9 and B12 in children with ADHD. Methods: We searched electronic databases including Web of Science, MEDLINE, EMBASE, Scopus, Iran MEDEX, Cochran database, and SID from conception to June 2023. Full-text case-control or cross-sectional studies were included in this study. Participants in the case group were children with ADHD aged 6-12 years. Review Manager Software (RevMan 5.4) was used for statistical analyses. Standardized mean differences (SMD) with 95% CIs were used to determine the differences between the two groups. Results: Six studies were included in the present meta-analysis. They included 982 children, of whom, 204 were girls and 744 were boys. The mean age of the children was 8.86±2.03 years. The level of vitamin B9 was significantly different between children with and without ADHD [SMD -0.80, 95% CI (-1.55, -0.04)]. Vitamin B12 was significantly lower in children with ADHD [SMD -0.29, 95% CI (-0.42, -0.16)]. However, due to high heterogeneity (I2 = 93%), sensitivity analysis was used, I2 fell to 21%, and significant difference was observed between the two groups [SMD -0.19, 95% CI (-0.34, -0.04)]. Conclusion: The results of this systematic review showed that the level of vitamins B9 and B12 in children with ADHD was significantly lower than that in healthy children.

03
SYSTEMATIC REVIEW International journal of molecular sciences (2024) PMID: 38542319 ↗
Unmasking the Metabolite Signature of Bladder Cancer: A Systematic Review.
Clinical Trial Synthesis 2024 Systematic Review published in International journal of molecular sciences. Key conclusion: The data from these comparisons suggest that increased concentrations of L-isoleucine, L-carnitine, oleamide, palmitamide, arachidonic acid and glycoursodeoxycholic acid and decreased content of deoxycytidine, 5-aminolevulinic acid and pantothenic acid should be considered compon
View Original PubMed Abstract ↓

Bladder cancer (BCa) research relying on Omics approaches has increased over the last few decades, improving the understanding of BCa pathology and contributing to a better molecular classification of BCa subtypes. To gain further insight into the molecular profile underlying the development of BCa, a systematic literature search was performed in PubMed until November 2023, following the PRISMA guidelines. This search enabled the identification of 25 experimental studies using mass spectrometry or nuclear magnetic resonance-based approaches to characterize the metabolite signature associated with BCa. A total of 1562 metabolites were identified to be altered by BCa in different types of samples. Urine samples displayed a higher likelihood of containing metabolites that are also present in bladder tumor tissue and cell line cultures. The data from these comparisons suggest that increased concentrations of L-isoleucine, L-carnitine, oleamide, palmitamide, arachidonic acid and glycoursodeoxycholic acid and decreased content of deoxycytidine, 5-aminolevulinic acid and pantothenic acid should be considered components of a BCa metabolome signature. Overall, molecular profiling of biological samples by metabolomics is a promising approach to identifying potential biomarkers for early diagnosis of different BCa subtypes. However, future studies are needed to understand its biological significance in the context of BCa and to validate its clinical application.

04
SYSTEMATIC REVIEW Nutrients (2023) PMID: 36839219 ↗
Demand for Water-Soluble Vitamins in a Group of Patients with CKD versus Interventions and Supplementation-A Systematic Review.
Clinical Trial Synthesis 2023 Systematic Review published in Nutrients. Key conclusion: CONCLUSIONS: Taking into account the research conducted so far, it seems that the use of vitamin supplementat
View Original PubMed Abstract ↓

BACKGROUND: Increasingly, chronic kidney disease (CKD) is becoming an inevitable consequence of obesity, metabolic syndrome, and diabetes. As the disease progresses, and through dialysis, the need for and loss of water-soluble vitamins both increase. This review article looks at the benefits and possible risks of supplementing these vitamins with the treatment of CKD. METHODS: Data in the PubMed and Embase databases were analyzed. The keywords "chronic kidney disease", in various combinations, are associated with thiamin, riboflavin, pyridoxine, pantothenic acid, folates, niacin, cobalamin, and vitamin C. This review focuses on the possible use of water-soluble vitamin supplementation to improve pharmacological responses and the overall clinical condition of patients. RESULTS: The mechanism of supportive supplementation is based on reducing oxidative stress, covering the increased demand and losses resulting from the treatment method. In the initial period of failure (G2-G3a), it does not require intervention, but later, especially in the case of inadequate nutrition, the inclusion of supplementation with folate and cobalamin may bring benefits. Such supplementation seems to be a necessity in patients with stage G4 or G5 (uremia). Conversely, the inclusion of additional B6 supplementation to reduce CV risk may be considered. At stage 3b and beyond (stages 4-5), the inclusion of niacin at a dose of 400-1000 mg, depending on the patient's tolerance, is required to lower the phosphate level. The inclusion of supplementation with thiamine and other water-soluble vitamins, especially in peritoneal dialysis and hemodialysis patients, is necessary for reducing dialysis losses. Allowing hemodialysis patients to take low doses of oral vitamin C effectively reduces erythropoietin dose requirements and improves anemia in functional iron-deficient patients. However, it should be considered that doses of B vitamins that are several times higher than the recommended dietary allowance of consumption may exacerbate left ventricular diastolic dysfunction in CKD patients. CONCLUSIONS: Taking into account the research conducted so far, it seems that the use of vitamin supplementat

05
CLINICAL STUDY Clinical nutrition (Edinburgh, Scotland) (2022) PMID: 35365361 ↗
ESPEN micronutrient guideline.
Clinical Trial Synthesis 2022 Meta-Analysis published in Clinical nutrition (Edinburgh, Scotland). Key conclusion: CONCLUSION: This guideline should enable addressing suboptimal and deficient status of a bundle of MNs in at-risk diseases.
View Original PubMed Abstract ↓

BACKGROUND: Trace elements and vitamins, named together micronutrients (MNs), are essential for human metabolism. Recent research has shown the importance of MNs in common pathologies, with significant deficiencies impacting the outcome. OBJECTIVE: This guideline aims to provide information for daily clinical nutrition practice regarding assessment of MN status, monitoring, and prescription. It proposes a consensus terminology, since many words are used imprecisely, resulting in confusion. This is particularly true for the words "deficiency", "repletion", "complement", and "supplement". METHODS: The expert group attempted to apply the 2015 standard operating procedures (SOP) for ESPEN which focuses on disease. However, this approach could not be applied due to the multiple diseases requiring clinical nutrition resulting in one text for each MN, rather than for diseases. An extensive search of the literature was conducted in the databases Medline, PubMed, Cochrane, Google Scholar, and CINAHL. The search focused on physiological data, historical evidence (published before PubMed release in 1996), and observational and/or randomized trials. For each MN, the main functions, optimal analytical methods, impact of inflammation, potential toxicity, and provision during enteral or parenteral nutrition were addressed. The SOP wording was applied for strength of recommendations. RESULTS: There was a limited number of interventional trials, preventing meta-analysis and leading to a low level of evidence. The recommendations underwent a consensus process, which resulted in a percentage of agreement (%): strong consensus required of >90% of votes. Altogether the guideline proposes sets of recommendations for 26 MNs, resulting in 170 single recommendations. Critical MNs were identified with deficiencies being present in numerous acute and chronic diseases. Monitoring and management strategies are proposed. CONCLUSION: This guideline should enable addressing suboptimal and deficient status of a bundle of MNs in at-risk diseases. In particular, it offers practical advice on MN provision and monitoring during nutritional support.

06
META-ANALYSIS Annals of palliative medicine (2021) PMID: 34154361 ↗
Clinical efficacy of vitamin B in the treatment of mouth ulcer: a systematic review and meta-analysis.
Clinical Trial Synthesis 2021 Meta-Analysis published in Annals of palliative medicine involving n = 1,534 participants; statistical significance reported at p = 0.001 (OR 0.194). Key conclusion: Additionally, both the ulcer healing time [standardized mean difference (SMD) =-2.15, 95% CI: -2.80 to -1.50, P<0.001] and treatment time (SMD =-2.31, 95% CI: -2.67 to -1.96, P<0.001) in the treatment group were shorter than those of the control group.
View Original PubMed Abstract ↓

BACKGROUND: Our study sought to determine the efficacy of vitamin B in treating mouth ulcers. METHODS: The databases PubMed, Web of Science, Embase, Chinese National Knowledge Infrastructure (CNKI), and Wanfang were comprehensively searched to identify relevant articles published between 2010 and 2021. Subsequently, the clinical efficacy of vitamin B in the treatment of mouth ulcers was comprehensively and quantitatively evaluated through meta-analysis. RESULTS: Totally, 16 studies were finally included in the meta-analysis, including 1,534 patients. Patients who did not receive treatment were taken as controls, while those who were treated with vitamin B alone or vitamin B combined with pantothenic acid were included in the treatment group. In comparison with the control group, the effective rate was higher [odds ratio (OR) =5.24, 95% confidence interval (CI): 3.72 to 7.37, P<0.001] while the recurrence rate was lower (OR =0.194, 95% CI: 0.128 to 0.295, P<0.001) in the treatment group. Additionally, both the ulcer healing time [standardized mean difference (SMD) =-2.15, 95% CI: -2.80 to -1.50, P<0.001] and treatment time (SMD =-2.31, 95% CI: -2.67 to -1.96, P<0.001) in the treatment group were shorter than those of the control group. DISCUSSION: Vitamin B enables a higher effective rate and lower recurrence rate, accelerates ulcer healing, and shortens the course of treatment. Collectively, vitamin B has a high clinical value in treating patients with mouth ulcers.

07
META-ANALYSIS Journal of thrombosis and thrombolysis (2012) PMID: 22743781 ↗
Association between B-group vitamins and venous thrombosis: systematic review and meta-analysis of epidemiological studies.
Clinical Trial Synthesis 2012 Meta-Analysis published in Journal of thrombosis and thrombolysis. Key conclusion: Reduced levels of folic acid and vitamin B12 may be independent risk factors of VT.
View Original PubMed Abstract ↓

A homocysteine-independent role for B-group vitamins on venous thrombosis (VT) development has been reported. However, related research findings remain inconsistent. PUBMED, EMBASE, and COCHRANE databases were searched to collect information on all eligible studies to make a meta-analysis about the relationship between B-group vitamins and VT. Literature search results did not suggest a correlation between thiamin, pantothenic acid, niacin, or riboflavin with VT. Based on their correlations in the literature, folic acid, vitamin B12, B6 were considered in the meta-analysis and systematic review. Significant standardized mean differences were obtained for plasma folic acid (-0.55; 95% CI, -0.75 to -0.36) and vitamin B12 (-0.34; 95% CI, -0.55 to -0.13). Reduced levels of folic acid and vitamin B12 may be independent risk factors of VT. Moreover, a qualitative systematic review indicated that low level of vitamin B6 was an independent risk factor of VT. Randomized clinical studies of B-group vitamins supplementation showed varying results on VT prevention. Multivitamin supplementation for VT prevention, regardless of homocysteine level, would be of interest. Further prospective clinical studies are needed to provide additional evidence on the clinical benefits of B-group vitamin supplementation for VT.

08
SYSTEMATIC REVIEW Journal of obstetric, gynecologic, and neonatal nursing (2005) PMID: 16020410 ↗
Prevention of and therapies for nipple pain: a systematic review.
Clinical Trial Synthesis 2005 Systematic Review published in Journal of obstetric, gynecologic, and neonatal nursing. Key conclusion: The most important factor in decreasing the incidence of nipple pain is the provision of education in relation to proper breastfeeding technique and latch-on as well as anticipatory guidance regarding the high incidence of early postpartum nipple pain.
View Original PubMed Abstract ↓

OBJECTIVE: To review the literature on nipple pain and to delineate effective strategies for the prevention and treatment of nipple pain in breastfeeding mothers. DATA SOURCES: Computerized searches on MEDLINE, Pre-MEDLINE, CINAHL, and the Cochrane Library. STUDY SELECTION: Articles from indexed journals relevant to the objective were reviewed from January 1983 to April 2004. Preference was given to research-based studies in English. DATA EXTRACTION: Data were extracted and organized under two headings: prevention of nipple pain or trauma and treatment of nipple pain or trauma. The Critical Appraisal Form by J. Briggs was used to extract the data from research-based articles. DATA SYNTHESIS: The health benefits of breastfeeding for mother and infant are well documented; however, nipple pain is a common reason reported by women for the early termination of breastfeeding. Several studies have compared various treatments for either the prevention of or treatment for nipple pain. These treatments include warm water compresses, tea bag compresses, heat, application of expressed mother's milk, lanolin, vitamin A, collagenase, dexpanthenol, hydrogel therapy, glycerin gel therapy, moist occlusive dressing, education regarding proper latch-on and positioning, and no treatment. CONCLUSIONS: No one topical agent showed superior results in the relief of nipple discomfort. The most important factor in decreasing the incidence of nipple pain is the provision of education in relation to proper breastfeeding technique and latch-on as well as anticipatory guidance regarding the high incidence of early postpartum nipple pain.

09
CLINICAL STUDY Clinical and translational science (2025) PMID: 40952900 ↗
Safety, Pharmacokinetics, and Pharmacodynamics of BI 1595043, a Selective Vanin Inhibitor, in Phase 1 Clinical Trials Involving Healthy Volunteers.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Clinical and translational science involving n = 10 participants. Key conclusion: BI 1595043 achieved rapid absorption after administration (median time from dosing to maximum measured concentration of the analyte in plasma: ~1 h) and plasma concentrations generally increased in a dose-proportional manner, with the majority excreted in urine within the first 2
View Original PubMed Abstract ↓

BI 1595043 is an oral vanin-1 and vanin-2 inhibitor, which demonstrated promising effects on epithelial cell protection and reduction of inflammatory mediators in preclinical studies, as well as an acceptable safety profile in a previous single-rising-dose trial. Here, we report the results of a double-blind, randomized, placebo-controlled, multiple rising dose study, which investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1595043 in healthy male volunteers following oral administration of single and multiple rising doses over 18 days in total. Thirty subjects were treated (18-50 years of age; body mass index: 18.5-29.9 kg/m2); each dose group included 10 subjects, of which eight were administered BI 1595043 (15, 30, or 60 mg) and two were administered placebo after an overnight fast of ≥ 10 h. With multiple rising doses, BI 1595043 appeared to effectively inhibit the conversion of pantetheine to pantothenic acid. BI 1595043 achieved rapid absorption after administration (median time from dosing to maximum measured concentration of the analyte in plasma: ~1 h) and plasma concentrations generally increased in a dose-proportional manner, with the majority excreted in urine within the first 24 h after dosing. Most adverse events reported were of mild or moderate severity, e.g., headache, dizziness, and abdominal discomfort. However, this study was temporarily halted after ophthalmologic adverse events judged to be drug-related by the investigator were reported in six subjects treated with BI 1595043. The study was discontinued prematurely due to the sponsor's decision to terminate the development of BI 1595043 in all indications. © 2025 Boehringer Ingelheim Pharmaceuticals. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.

10
RANDOMIZED TRIAL (RCT) Journal of cosmetic dermatology (2025) PMID: 40613435 ↗
Evaluation of the Efficacy and Safety of a Panthenol-Enriched Mask for Skin Barrier Recovery After Facial Laser Treatment: Results of a Double-Blind Randomized Controlled Study.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Journal of cosmetic dermatology involving n = 60 participants. Key conclusion: CONCLUSION: A panthenol-enriched Mask effectively decreased post non-ablative laser erythema, enhanced skin hydration, and promoted skin barrier repair.
View Original PubMed Abstract ↓

BACKGROUND: Facial laser procedures may result in compromised skin barrier function and associated discomfort. It is essential to address these issues to facilitate a swift recovery and enhance patient satisfaction. OBJECTIVE: To evaluate the efficacy and safety of a panthenol-enriched mask, incorporating centella asiatica extract (madecassoside) and bisabolol, in repairing the skin barrier after 1550 and 1927 nm dual-wavelength non-ablative fractional laser therapy. METHODS: A total of 60 subjects were enrolled in this double-blind randomized study and were divided into Control group (CG) and Mask group (MG). Both groups received standard post-operative care, the MG receiving the Mask, while the CG received a saline dressing. Skin barrier repair was assessed using a skin physiological detection instrument, colorimetry, and a skin imaging analyzer (VISIA). The incidence of adverse reactions was also monitored. RESULTS: The MG exhibited significantly lower erythema index and hyperpigmentation index at D3, D7, and D14, compared to the CG. The MG had significantly higher sebum content than the CG at D7 and D14. The stratum corneum moisture content in the MG was also higher than in the CG at D3, D7, and D14. Additionally, transepidermal water loss (TEWL) was significantly reduced in the MG at D3, D7, and D14. There was no significant difference in the rate of adverse reactions between the groups. CONCLUSION: A panthenol-enriched Mask effectively decreased post non-ablative laser erythema, enhanced skin hydration, and promoted skin barrier repair. © 2025 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.

RELATED MONOGRAPHS

Related Monographs in This Category