Clinical trial NCT04534140: Skin Hydration in Persons With Acne After Dietary Supplementation With Botanical Antioxidants
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Acne Vulgaris
Acne
Keywords: antioxidants
acne
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Botanical Impact on hydration in those with Acne Vulgaris
timeFrame: 8 weeks
Secondary outcomes:
measure: Botanical Impact on Acne Vulgaris
timeFrame: 8 weeks
measure: Botanical Impact on Quality of Life in those with Acne
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutrition, 1000 Veteran Ave.
state: California
Study officials:
affiliation: UCLA Professor of Medicine
name: Zhaoping Li
role: PRINCIPAL_INVESTIGATOR
References: