Acne VulgarisKIWIBOOSTERNCT04534140
Skin Hydration in Persons With Acne After Dietary Supplementation With Botanical Antioxidants
A study testing HBKB Capsule in people with Acne Vulgaris and Acne, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris, Acne
- What is being tested?
- HBKB Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 24 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition, 1000 Veteran Ave.
Los Angeles, California, 90095
About this study
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
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.
Read the 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
- Conditions
- Acne Vulgaris, Acne
- Being tested
- HBKB Capsule, HBKB Supplement Vehicle
- Keywords
- antioxidants, acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBKB CapsuleDietary supplement
The botanical dietary supplement 'Halo Beauty Kiwi Booster' (HBKB) taken daily orally.
HBKB Supplement VehicleOther
Control group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| HBKB Capsule | Experimental | Experimental group participants will take one capsule of the HBKB botanical dietary supplement orally, once daily Receives: Dietary Supplement: HBKB Capsule |
| HBKB Capsule Vehicle | Placebo comparator | Control group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily Receives: Other: HBKB Supplement Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
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)
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start25 Jan 2021 (estimated)
- Primary completion24 Jan 2023 (estimated)
- Study completion24 Jan 2023 (estimated)
Why it stopped: Contract not negotiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, Principal investigator, UCLA Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534140
- Sponsor's protocol ID
- 19-002095
- Acronym
- KIWIBOOSTER
- Status last verified
- Jan 2021
- First submitted
- 26 Aug 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04534140
- Acronym / sponsor ID
- KIWIBOOSTER / 19-002095
- Conditions
- Acne Vulgaris, Acne
- Keywords
- antioxidants, acne
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Contract not negotiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 25 Jan 2021 (estimated)
- Primary completion
- 24 Jan 2023 (estimated)
- Study completion
- 24 Jan 2023 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a 2-armed investigational group (botanical dietary supplement) and placebo group (supplement vehicle), double-blind, randomized, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| HBKB Capsule | Experimental | Dietary Supplement: HBKB CapsuleExperimental group participants will take one capsule of the HBKB botanical dietary supplement orally, once daily |
| HBKB Capsule Vehicle | Placebo comparator | Other: HBKB Supplement VehicleControl group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBKB CapsuleThe botanical dietary supplement 'Halo Beauty Kiwi Booster' (HBKB) taken daily orally. | Dietary supplement | HBKB Capsule |
| HBKB Supplement VehicleControl group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily | Other | HBKB Capsule Vehicle |
Primary outcome
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.
2 secondary outcomes
Botanical Impact on Acne Vulgaris
Time frame: 8 weeks
Botanical Impact on Quality of Life in those with Acne
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li principal investigator
UCLA Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBKB Capsule in people with Acne Vulgaris and Acne, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Botanical Impact on hydration in those with Acne Vulgaris (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.