Skin Hydration in Persons With Acne After Dietary Supplementation With Botanical Antioxidants

Acne Vulgaris Clinical Trial

— KIWIBOOSTER  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04534140
• Other study ID #: 19-002095
• Status: Withdrawn
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: January 24, 2023

Study information

• Verified date: January 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 life for those with acne.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 24, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Dietary Supplement:
• HBKB Capsule
The botanical dietary supplement 'Halo Beauty Kiwi Booster' (HBKB) taken daily orally.

Other:
• HBKB Supplement Vehicle
Control group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily

Locations

Country	Name	City	State
United States	UCLA Center for Human Nutrition, 1000 Veteran Ave.	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	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)	8 weeks
Secondary	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.	8 weeks