Almond Supplementation on Mild to Moderate Acne

Not Applicable

Recruiting

• Conditions: Acne Vulgaris

• Registration Number: NCT05269641
• Lead Sponsor: Integrative Skin Science and Research

Brief Summary

This study will assess the effect of almond supplementation on acne and on gut health.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-12
• Study First Submitted QC: 2022-02-25
• Last Update Submitted: 2022-02-25
• Study Start: 2022-02-28
• Study First Posted: 2022-03-08
• Last Update Posted: 2022-03-08
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total lesion count	20 weeks	Number of of inflammatory lesions, and open and closed comedones

Secondary Outcome Measures

Name	Time	Method
Inflammatory lesion count	20 weeks	Number of inflammatory lesions
Non-inflammatory lesion count	20 weeks	Number of open and closed comedones
Investigator global assessment (IGA) of acne	20 weeks	Validated scale for global assessment of acne. Scale of 0-4, 4 indicating greater severity.
Quality of Life Survey	20 weeks	Dermatology quality of life index survey assessment (DQLI). Scale is 0 to 30, the higher the score the greater impairments to quality of life.
Sebum excretion	20 weeks	Measure of skin sebum via sebumeter
Gut microbiome assessment	20 weeks	Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Skin microbiome diversity	20 weeks	Shift in the Shannon diversity of the skin microbiome through adhesive strip and swab collection.

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States