SuspendedNot Applicable

The Effect of Nutritional Supplementation on Actinic Purpura: A Pilot Study

Stopped: Change in sponsor priority.

United States30 participantsStarted 2025-04-01

Plain-language summary

Purpura is a macule or papule of blood in the skin. It is mostly seen in mature skin that is often prone to significant bruising. Small lesions of less than 5 mm are called petechiae and larger ones, found mostly in subcutaneous tissue, are called ecchymosis. Actinic purpura occurs almost exclusively in elderly populations. This single-blind randomized clinical trial evaluates the effect of an 8-week nutritional supplement intervention in comparison with isolated vitamin C supplements on actinic purpura in older adults. We will enroll thirty (30) otherwise healthy participants, both male and female, aged 55 years and older. Changes in participants' skin condition will be assessed at visit 1 (baseline), visit 2 (4-week), and visit 3 (8-week) using questionnaires, standard digital photography, and clinical grading of the skin lesions.

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female individuals aged ≥ 55 years old. * Self-reported having actinic purpura lesions at the time of enrollment or a history of actinic purpura lesions. * Self-reported not using prescription or over-the-counter products that contain aluminum, iron, proton pump inhibitors (PPIs), and/or topical retinol (used locally in areas of bruising). * If on a chronic medication that does not result in exclusion, participant must self-report being on a stable dose for the last 3 months prior to the start of the trial. * Able and willing to read and voluntarily sign the study Informed Consent Form (ICF). * Able and willing to comply with study protocol and all study-related guidelines. * Not concomitantly participating in a study involving nutritional products. Exclusion Criteria: * Not complying with the study protocol. * Having a known allergy or intolerance to nuts, seeds, fruits, vegetables, oils, and fish. * Having a known allergy, intolerance, or dietary restriction to any of the study ingredients (Vitamin C, organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid, and calcium stearate). * Having a clinically significant condition that is severe, progressive, or uncontrolled and would compromise the study or their well-being or would prevent the participant from meeting or performing study requirements. This includes but is not limited to dysphagia (or difficulty swallo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Endpoint

Timeframe: 8 weeks

Trial details

NCT IDNCT06840574

SponsorStandard Process Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-30

View on ClinicalTrials.gov More Skin Health trials