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

Not Applicable

Withdrawn

• Conditions: Acne Vulgaris; Acne
• Interventions: Other: HBKB Supplement Vehicle; Dietary Supplement: HBKB Capsule

• 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• Status: WITHDRAWN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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HBKB Capsule Vehicle	HBKB Supplement Vehicle	Control group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily
HBKB Capsule	HBKB Capsule	Experimental group participants will take one capsule of the HBKB botanical dietary supplement orally, once daily

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