Skin Hydration in Persons With Acne After Dietary Supplementation With Botanical Antioxidants

NCT ID: NCT04534140

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2023-01-24

Brief Summary

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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.

Detailed Description

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The study will be a 2-armed investigational trial with one group receiving botanical dietary supplement and one placebo group provided with the similar supplement vehicle. The trial will be double-blind, randomized, parallel-group study. The investigational group will receive the botanical dietary supplement 'Halo Beauty Kiwi Booster' (HBKB), to be taken orally daily for 8 weeks. Control group participants will receive the HBKB botanical dietary supplement vehicle as a placebo to be taken orally daily for 8 weeks.Participants will have their skin assessed

Conditions

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Acne Vulgaris Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a 2-armed investigational group (botanical dietary supplement) and placebo group (supplement vehicle), double-blind, randomized, parallel-group study.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HBKB Capsule

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

Group Type EXPERIMENTAL

HBKB Capsule

Intervention Type DIETARY_SUPPLEMENT

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

HBKB Capsule Vehicle

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

Group Type PLACEBO_COMPARATOR

HBKB Supplement Vehicle

Intervention Type OTHER

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

Interventions

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HBKB Capsule

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

Intervention Type DIETARY_SUPPLEMENT

HBKB Supplement Vehicle

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Zhaoping Li

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhaoping Li

Role: PRINCIPAL_INVESTIGATOR

UCLA Professor of Medicine

Locations

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UCLA Center for Human Nutrition, 1000 Veteran Ave.

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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19-002095

Identifier Type: -

Identifier Source: org_study_id

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