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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Acne, Acne Vulgaris

Intervention / Treatment
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* Dietary Supplement: HBKB Capsule
* Other: HBKB Supplement Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBKB Capsule<br>Experimental group participants will take one capsule of the HBKB botanical dietary supplement orally, once daily | Dietary Supplement: HBKB Capsule<br>* The botanical dietary supplement 'Halo Beauty Kiwi Booster' (HBKB) taken daily orally.<br>|
| Placebo Comparator: HBKB Capsule Vehicle<br>Control group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily | Other: HBKB Supplement Vehicle<br>* Control group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antioxidants, acne