- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04534140
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Withdrawn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
-
-
California
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Los Angeles, California, United States, 90095
- UCLA Center for Human Nutrition, 1000 Veteran Ave.
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-
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
|
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
|
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.
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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-
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