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

Launched by STANDARD PROCESS INC. · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a special nutritional supplement can help improve a skin condition called actinic purpura, which causes easy bruising and is common in older adults. The study will compare the effects of this nutritional supplement to just taking vitamin C for eight weeks. Researchers will enroll 30 participants aged 55 and older who have either current or past issues with actinic purpura. To be eligible, participants should not be using certain medications or products that might interfere with the study and must not have any major health issues that could complicate their participation.

Participants in the trial can expect to attend three visits over the eight weeks. At the first visit, they will answer questions about their skin and have photos taken to assess their condition. After four weeks and again at eight weeks, their skin will be checked again to see if there are any changes. It's important for potential participants to know that they should not have any significant allergies to the ingredients in the supplement or any serious skin conditions that could affect the study. This trial is not yet recruiting participants, but it aims to better understand how nutrition can support skin health in older adults.

Gender

ALL

Eligibility criteria

• 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 swallowing), liver or kidney disease, bone marrow problems, Ehlers-Danlos syndrome, lupus, alcohol misuse, cancer, or HIV and other infections.
• • Having active dermatological conditions. Patients with active, severe skin conditions that might interfere with the study's conduct or outcomes including widespread psoriasis, untreated chronic skin ulcers, or other severe dermatological disorders.