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Skin Hydration in Persons With Acne After Dietary Supplementation With Botanical Antioxidants (KIWIBOOSTER)

Primary Purpose

Acne Vulgaris, Acne

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HBKB Capsule

HBKB Supplement Vehicle

About this trial

This is an interventional other trial for Acne Vulgaris focused on measuring antioxidants, acne

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UCLA Center for Human Nutrition, 1000 Veteran Ave.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HBKB Capsule

HBKB Capsule Vehicle

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Botanical Impact on Acne Vulgaris

To prospectively appraise changes in Investigator Global Assessment (IGA) of Facial AV after dietary supplementation with a compilation of botanical antioxidants.Scale is 0-4 (0 - clear and 4 - severe)

Botanical Impact on Quality of Life in those with Acne

To prospectively appraise changes in AV related quality-of-life (AVQoL) after dietary supplementation with a compilation of botanical antioxidants.

Full Information

NCT ID

NCT04534140

First Posted

August 26, 2020

Last Updated

January 25, 2021

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT04534140

Brief Title

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

Acronym

KIWIBOOSTER

Official Title

Evaluating the Effect of an Antioxidant Nutraceutical on Skin Health, as Measured by Investigator Global Assessment, Quality-of-Life, and Corneometry, in Persons With Mild to Moderately Severe Facial Acne Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Contract not negotiated.

Study Start Date

January 25, 2021 (Anticipated)

Primary Completion Date

January 24, 2023 (Anticipated)

Study Completion Date

January 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris, Acne

Keywords

antioxidants, acne

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HBKB Capsule

Arm Type

Experimental

Arm Description

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

Arm Title

HBKB Capsule Vehicle

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

HBKB Capsule

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

HBKB Supplement Vehicle

Intervention Description

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

Primary Outcome Measure Information:

Title

Botanical Impact on hydration in those with Acne Vulgaris

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Botanical Impact on Acne Vulgaris

Description

Time Frame

8 weeks

Title

Botanical Impact on Quality of Life in those with Acne

Description

To prospectively appraise changes in AV related quality-of-life (AVQoL) after dietary supplementation with a compilation of botanical antioxidants.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaoping Li

Organizational Affiliation

UCLA Professor of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA Center for Human Nutrition, 1000 Veteran Ave.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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