Almond Supplementation on Mild to Moderate Acne | NCT05269641

Studies
Almond Supplementation on Mild to Moderate Acne

NCT05269641

Sponsor

Integrative Skin Science and Research

Status

Unknown status

Last Update Posted

Mar 8, 2022Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Acne Vulgaris

Interventions

Food: whole almonds
Food: non-nut snack

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2022Estimated

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Feb 12, 2022

First Submission Date that Met QC Criteria

Feb 25, 2022

First Posted Date

Mar 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2022

Last Update Posted Date

Mar 8, 2022Actual

Name	Class
Almond Board of California	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Almonds	Experimental	Daily consumption of almonds.	Other: Food: whole almonds
Control Snack	Placebo Comparator	Daily non-nut snack will be consumed.	Other: Food: non-nut snack

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Food: whole almonds	Other	60g of whole almonds will be consumed daily.	Almonds

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total lesion count	Number of of inflammatory lesions, and open and closed comedones	20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Inflammatory lesion count	Number of inflammatory lesions	12 weeks
Inflammatory lesion count	Number of inflammatory lesions	20 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jessica Maloh	Contact	9167502463		jessica@integrativeskinresearch.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Integrative Skin Science and Research	Recruiting	Sacramento	California	95819	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided