Skin HealthNCT06840574
The Effect of Nutritional Supplementation on Actinic Purpura: A Pilot Study
A study testing Cyruta Plus: A Whole-Food Based Vitamin C supplement containing organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid, Low Dose Vitamin C and High Dose Vitamin C in people with Skin Health and Skin Aging of Face and Hands, run by Standard Process Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Health, Skin Aging of Face and Hands, Healthy
- What is being tested?
- Cyruta Plus: A Whole-Food Based Vitamin C supplement containing organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid, Low Dose Vitamin C and High Dose Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Standard Process - Nutrition Innovation Center
Kannapolis, North Carolina, 28081
About this study
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.
- Conditions
- Skin Health, Skin Aging of Face and Hands, Healthy, Ecchymosis
- Being tested
- Cyruta Plus: A Whole-Food Based Vitamin C supplement containing organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid, Low Dose Vitamin C, High Dose Vitamin C
- Medical subject headings
- Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyruta Plus: A Whole-Food Based Vitamin C supplement containing organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acidDietary supplement
27 mg vitamin C, organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid, and calcium stearate
Low Dose Vitamin CDietary supplement
27 mg ascorbic acid
High Dose Vitamin CDietary supplement
500 mg ascorbic acid
| Study group | Role | What they receive |
|---|---|---|
| Cyruta Plus | Experimental | Total of 27 mg daily Receives: Dietary Supplement: Cyruta Plus: A Whole-Food Based Vitamin C supplement containing organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid |
| Low-dose Vitamin C | Active comparator | Total of 27 mg daily Receives: Dietary Supplement: Low Dose Vitamin C |
| High-dose Vitamin C | Active comparator | Total of 500 mg daily Receives: Dietary Supplement: High Dose Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
The number of participants who report a reduction in the number of purpura lesions as evaluated through dermatological examination before and after supplementation.
Measured: 8 weeks
Secondary outcomes (1)
Secondary Endpoint
Average decrease in actinic purpura lesion measurements in millimeters across participants.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Apr 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Why it stopped: Change in sponsor priority.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Standard Process Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840574
- Sponsor's protocol ID
- SP0022 Cyruta Plus
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutritional Supplementation on Actinic Purpura: A Pilot Study
- ClinicalTrials.gov ID
- NCT06840574
- Acronym / sponsor ID
- SP0022 Cyruta Plus
- Conditions
- Skin Health, Skin Aging of Face and Hands, Healthy, Ecchymosis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Change in sponsor priority.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Standard Process Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cyruta Plus | Experimental | Dietary Supplement: Cyruta Plus: A Whole-Food Based Vitamin C supplement containing organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acidTotal of 27 mg daily |
| Low-dose Vitamin C | Active comparator | Dietary Supplement: Low Dose Vitamin CTotal of 27 mg daily |
| High-dose Vitamin C | Active comparator | Dietary Supplement: High Dose Vitamin CTotal of 500 mg daily |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyruta Plus: A Whole-Food Based Vitamin C supplement containing organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid27 mg vitamin C, organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid, and calcium stearate | Dietary supplement | Cyruta Plus |
| Low Dose Vitamin C27 mg ascorbic acid | Dietary supplement | Low-dose Vitamin C |
| High Dose Vitamin C500 mg ascorbic acid | Dietary supplement | High-dose Vitamin C |
Primary outcome
Primary Endpoint
Time frame: 8 weeks
The number of participants who report a reduction in the number of purpura lesions as evaluated through dermatological examination before and after supplementation.
1 secondary outcome
Secondary Endpoint
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyruta Plus: A Whole-Food Based Vitamin C supplement containing organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid, Low Dose Vitamin C and High Dose Vitamin C in people with Skin Health and Skin Aging of Face and Hands, run by Standard Process Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.