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

January 25, 2021 updated by: Zhaoping Li, University of California, Los Angeles

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Center for Human Nutrition, 1000 Veteran Ave.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HBKB Capsule
Experimental group participants will take one capsule of the HBKB botanical dietary supplement orally, once daily
Dietary supplement: HBKB Capsule
The botanical dietary supplement 'Halo Beauty Kiwi Booster' (HBKB) taken daily orally.
Placebo Comparator: HBKB Capsule Vehicle
Control group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily
Other: HBKB Supplement Vehicle
Control group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Botanical Impact on hydration in those with Acne Vulgaris
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Botanical Impact on Acne Vulgaris
Time Frame: 8 weeks
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)
8 weeks
Botanical Impact on Quality of Life in those with Acne
Time Frame: 8 weeks
To prospectively appraise changes in AV related quality-of-life (AVQoL) after dietary supplementation with a compilation of botanical antioxidants.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 25, 2021

Primary Completion (Anticipated)

January 24, 2023

Study Completion (Anticipated)

January 24, 2023

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-002095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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