Clinical trial NCT06840574: The Effect of Nutritional Supplementation on Actinic Purpura: A Pilot Study
Official title: The Effect of Nutritional Supplementation on Actinic Purpura: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Health
Skin Aging of Face and Hands
Healthy
Ecchymosis
Lead sponsor: Standard Process Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


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.

Primary outcomes:
measure: Primary Endpoint
timeFrame: 8 weeks
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: Standard Process - Nutrition Innovation Center
state: North Carolina
Study officials:
References: