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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects 15 years of age until 45 years of age
Be younger than 65 years old
Must not have
The presence of severe acne as noted by the investigator global assessment
Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Summary
This trial will study the effects of almond supplementation on acne and gut health.
Who is the study for?
This trial is for people aged 15-45 with mild to moderate acne who have been on a stable acne treatment for at least 4 weeks. It's not suitable for those with nut allergies, recent changes in hormonal contraception, heavy past tobacco use, or those using certain strong acne medications.
What is being tested?
The study is testing if eating whole almonds can improve acne and gut health compared to a non-nut snack. Participants will be given either almonds or the control snack to see which has better effects on their skin and digestion.
What are the potential side effects?
Since this trial involves food supplementation (almonds), side effects may include digestive discomfort or allergic reactions in individuals sensitive to nuts. Other specific side effects will depend on individual tolerances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 15 and 45 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with severe acne by a healthcare professional.
Select...
I currently smoke or have smoked a lot in the past.
Select...
I am willing to stop using topical antibiotics and benzoyl peroxide before joining.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total lesion count
Secondary study objectives
Gut microbiome assessment
Inflammatory lesion count
Investigator global assessment (IGA) of acne
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AlmondsExperimental Treatment1 Intervention
Daily consumption of almonds.
Group II: Control SnackPlacebo Group1 Intervention
Daily non-nut snack will be consumed.
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Who is running the clinical trial?
Integrative Skin Science and ResearchLead Sponsor
32 Previous Clinical Trials
1,914 Total Patients Enrolled
3 Trials studying Acne
202 Patients Enrolled for Acne
Almond Board of CaliforniaOTHER
34 Previous Clinical Trials
2,161 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with severe acne by a healthcare professional.I currently smoke or have smoked a lot in the past.I have taken an oral antibiotic for acne in the last month.My acne treatment has been the same for at least 4 weeks.You have switched your hormonal birth control within the last 3 months before joining the study.You have an allergy to nuts.I have not taken isotretinoin in the last 3 months.I am willing to stop using topical antibiotics and benzoyl peroxide before joining.You are taking a supplement that contains nuts.I am willing to stop taking probiotic supplements before joining.I am between 15 and 45 years old.I am willing to stop taking vitamin E supplements for the study.I have mild to moderate acne.
Research Study Groups:
This trial has the following groups:- Group 1: Control Snack
- Group 2: Almonds
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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