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

Not Applicable

Withdrawn

• Conditions: Acne Vulgaris; Acne

• Registration Number: NCT04534140
• Lead Sponsor: University of California, Los Angeles

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

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-09-01
• Status Verified: 2021-01
• Study Start: 2021-01-25
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-28
• Primary Completion: 2023-01-24
• Study Completion: 2023-01-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Botanical Impact on hydration in those with Acne Vulgaris	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

Name	Time	Method
Botanical Impact on Acne Vulgaris	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)
Botanical Impact on Quality of Life in those with Acne	8 weeks	To prospectively appraise changes in AV related quality-of-life (AVQoL) after dietary supplementation with a compilation of botanical antioxidants.

Trial Locations

Locations (1)

UCLA Center for Human Nutrition, 1000 Veteran Ave.; 🇺🇸 Los Angeles, California, United States