Acne VulgarisNCT05269641
Almond Supplementation on Mild to Moderate Acne
A study testing Food: whole almonds and Food: non-nut snack in people with Acne Vulgaris, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
This study will assess the effect of almond supplementation on acne and on gut health. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Food: whole almonds and Food: non-nut snack
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2022to 1 Dec 2024
- 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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects 15 years of age until 45 years of age.
- The presence of mild to moderate acne based on investigator global assessment.
- Individuals who have remained stable on their topical or oral acne regimen for at least 4 weeks, except if the medication is a noted exclusion.
Who cannot join
- The presence of severe acne as noted by the investigator global assessment.
- Those with a nut allergy.
- Those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling.
- Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling.
- Individuals who are unwilling to discontinue vitamin E containing supplements during the washout and intervention.
- Individuals who have been on an oral antibiotic for acne within the previous 1 month.
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- Individuals who are pregnant or breastfeeding.
- Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- Oral supplementation that has nuts in it.
- Use of isotretinoin within the three months prior to joining the study.
- Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrative Skin Science and Research
Sacramento, California, 95819
Jessica Maloh, 916-750-2463, raja.sivamani@integrativeskinresearch.com
Raja Sivamani, MD MS AP
About this study
Official title: The Effect of Almond Supplementation on Mild to Moderate Acne
This study will assess the effect of almond supplementation on acne and on gut health.
- Conditions
- Acne Vulgaris
- Being tested
- Food: whole almonds, Food: non-nut snack
- Keywords
- microbiome, nutrition
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food: whole almondsOther
60g of whole almonds will be consumed daily.
Food: non-nut snackOther
A non-nut snack will be consumed daily.
| Study group | Role | What they receive |
|---|---|---|
| Almonds | Experimental | Daily consumption of almonds. Receives: Other: Food: whole almonds |
| Control Snack | Placebo comparator | Daily non-nut snack will be consumed. Receives: Other: Food: non-nut snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total lesion count
Number of of inflammatory lesions, and open and closed comedones
Measured: 20 weeks
Secondary outcomes (14)
Inflammatory lesion count
Number of inflammatory lesions
Measured: 12 weeks
Inflammatory lesion count
Number of inflammatory lesions
Measured: 20 weeks
Non-inflammatory lesion count
Number of open and closed comedones
Measured: 12 weeks
Non-inflammatory lesion count
Number of open and closed comedones
Measured: 20 weeks
Investigator global assessment (IGA) of acne
Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.
Measured: 12 weeks
Investigator global assessment (IGA) of acne
Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.
Measured: 20 weeks
Quality of Life Survey
Dermatology quality of life index survey assessment (DQLI). Scale is 0 to 30, the higher the score the greater impairments to quality of life.
Measured: 12 weeks
Quality of Life Survey
Dermatology quality of life index survey assessment (DQLI). Scale is 0 to 30, the higher the score the greater impairments to quality of life.
Measured: 20 weeks
Sebum excretion
Measure of skin sebum via sebumeter.
Measured: 12 weeks
Sebum excretion
Measure of skin sebum via sebumeter
Measured: 20 weeks
Gut microbiome assessment
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Measured: 12 weeks
Gut microbiome assessment
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Measured: 20 weeks
Skin microbiome diversity
Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.
Measured: 12 weeks
Skin microbiome diversity
Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start28 Feb 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Almond Board of California
- Responsible party
- Principal investigator, Raja Sivamani, MD MS AP, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269641
- Sponsor's protocol ID
- AlmondAcne_01
- Status last verified
- Feb 2022
- First submitted
- 12 Feb 2022
- Last updated
- 8 Mar 2022
- 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Almond Supplementation on Mild to Moderate Acne
- ClinicalTrials.gov ID
- NCT05269641
- Acronym / sponsor ID
- AlmondAcne_01
- Conditions
- Acne Vulgaris
- Keywords
- microbiome, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Almond Board of California
- Study start
- 28 Feb 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 8 Mar 2022 (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.
This study will assess the effect of almond supplementation on acne and on gut health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almonds | Experimental | Other: Food: whole almondsDaily consumption of almonds. |
| Control Snack | Placebo comparator | Other: Food: non-nut snackDaily non-nut snack will be consumed. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Subjects 15 years of age until 45 years of age.
- The presence of mild to moderate acne based on investigator global assessment.
- Individuals who have remained stable on their topical or oral acne regimen for at least 4 weeks, except if the medication is a noted exclusion.
Key exclusion criteria (11 listed)
- The presence of severe acne as noted by the investigator global assessment.
- Those with a nut allergy.
- Those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling.
- Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling.
- Individuals who are unwilling to discontinue vitamin E containing supplements during the washout and intervention.
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 |
|---|---|---|
| Food: whole almonds60g of whole almonds will be consumed daily. | Other | Almonds |
| Food: non-nut snackA non-nut snack will be consumed daily. | Other | Control Snack |
Primary outcome
Total lesion count
Time frame: 20 weeks
Number of of inflammatory lesions, and open and closed comedones
14 secondary outcomes
Inflammatory lesion count
Time frame: 12 weeks
Inflammatory lesion count
Time frame: 20 weeks
Non-inflammatory lesion count
Time frame: 12 weeks
Non-inflammatory lesion count
Time frame: 20 weeks
Investigator global assessment (IGA) of acne
Time frame: 12 weeks
Investigator global assessment (IGA) of acne
Time frame: 20 weeks
Quality of Life Survey
Time frame: 12 weeks
Quality of Life Survey
Time frame: 20 weeks
Sebum excretion
Time frame: 12 weeks
Sebum excretion
Time frame: 20 weeks
Gut microbiome assessment
Time frame: 12 weeks
Gut microbiome assessment
Time frame: 20 weeks
Skin microbiome diversity
Time frame: 12 weeks
Skin microbiome diversity
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food: whole almonds and Food: non-nut snack in people with Acne Vulgaris, run by Integrative Skin Science and Research 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Mar 2022. 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. Some participants in this study may receive a placebo. 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?
Contact Jessica Maloh (9167502463, jessica@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total lesion count (time frame: 20 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 8 Mar 2022.