NCT04534140

Brief Summary

Antioxidants have been studied for their abilities to combat reactive oxygen species in a multitude of conditions. This study aims to assess whether the botanical dietary supplement 'Halo Beauty Kiwi Booster' (HBKB), taken orally daily for 8 weeks, can assist with Acne vulgaris as well as skin hydration and quality of life for those with acne.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2023

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

August 26, 2020

Last Update Submit

January 25, 2021

Conditions

Acne VulgarisAcne

Keywords

antioxidantsacne

Outcome Measures

Primary Outcomes (1)

  • Botanical Impact on hydration in those with Acne Vulgaris

    To prospectively appraise changes in stratum corneum hydration levels in persons with Acne Vulgaris (AV) after dietary supplementation with a compilation of botanical antioxidants.

    8 weeks

Secondary Outcomes (2)

  • Botanical Impact on Acne Vulgaris

    8 weeks

  • Botanical Impact on Quality of Life in those with Acne

    8 weeks

Study Arms (2)

HBKB Capsule

EXPERIMENTAL

Experimental group participants will take one capsule of the HBKB botanical dietary supplement orally, once daily

Dietary Supplement: HBKB Capsule

HBKB Capsule Vehicle

PLACEBO COMPARATOR

Control group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily

Other: HBKB Supplement Vehicle

Interventions

HBKB CapsuleDIETARY_SUPPLEMENT

The botanical dietary supplement 'Halo Beauty Kiwi Booster' (HBKB) taken daily orally.

HBKB Capsule
HBKB Supplement VehicleOTHER

Control group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily

HBKB Capsule Vehicle

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults 18-35 years of age able to provide consent to participate
  • IGA of mild to moderately severe facial Acne Vulgaris (AV) at screening
  • Potential participants with mild to moderately severe facial AV and with AV on their neck, shoulders, chest and/or back body surface areas may be included.

You may not qualify if:

  • An Investigator Global Assessment IGA of severe facial, neck, back or truncal AV
  • Diagnosis of a chronic inflammatory disease such as lupus, multiple sclerosis, cancer, Chron's disease or cancer
  • Allergies to Astaxanthin (microalgae), Grape Seed Extract, Kiwi fruit or Kiwi extract, Pineapple fruit or extract (bromelain), Rosehip or Rosehip extract, Gooseberry, Rosehip, Grapes
  • Secondary AV, such as occupational AV, steroid induced AV, or AV associated with endocrine disorders
  • Having facial dermatosis that may interfere evaluations by IGA such as sunburn, eczema, psoriasis, erythematotelangectatic rosacea or seborrheic dermatitis
  • Use of isotretinoin within 2 months
  • Use of adapalene or tretinoin within 2 weeks
  • Use of anti-biotics within 2 weeks
  • Use of oral corticosteroids or androgens within 2 weeks
  • Use of anticonvulsants
  • Any subject who the PI deems unsuitable for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Center for Human Nutrition, 1000 Veteran Ave.

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Zhaoping Li

    UCLA Professor of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This will be a 2-armed investigational group (botanical dietary supplement) and placebo group (supplement vehicle), double-blind, randomized, parallel-group study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 1, 2020

Study Start

January 25, 2021

Primary Completion

January 24, 2023

Study Completion

January 24, 2023

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)