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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04534140
Recruitment Status : Withdrawn (Contract not negotiated.)
First Posted : September 1, 2020
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Acne Dietary Supplement: HBKB Capsule Other: HBKB Supplement Vehicle Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Estimated Study Start Date : January 25, 2021
Estimated Primary Completion Date : January 24, 2023
Estimated Study Completion Date : January 24, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534140


Locations
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United States, California
UCLA Center for Human Nutrition, 1000 Veteran Ave.
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Zhaoping Li UCLA Professor of Medicine
More Information
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Responsible Party: Zhaoping Li, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04534140    
Other Study ID Numbers: 19-002095
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhaoping Li, University of California, Los Angeles:
antioxidants
acne
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases