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Clinical Study to Evaluate the Impact of aKwa Skincare System on Skin Health

Primary Purpose

Sin Health, Skin Hydration, Skin Wrinkles

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
äKwä skincare system products
competitor products (control)
Sponsored by
4Life Research, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sin Health

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals could participate who were at least 18 years old and in good health.

Exclusion Criteria:

  • had allergies or contraindications to any ingredient of products,
  • had a history of any acute or chronic disease that could interfere with or increase the risk of study participation
  • had any medical procedures, such as laser resurfacing, or plastic surgery to the test sites within the last 12 months (including Botox, Restylyn, or other fillers)
  • chronic skin allergies (dermatitis, eczema, psoriasis)
  • had been treated for skin cancer within the last 12 months or have damaged skin near the facial area (e.g., sunburn, tattoos, scars, or other disfigurations)
  • pregnant or planning to become pregnant in the following 12 weeks, or lactating

Sites / Locations

  • 4Life Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

äKwä Group

Control Group

Arm Description

participants use äKwä products daily as instructed for 30 days

participants use a competitor products daily as instructed for 30 days

Outcomes

Primary Outcome Measures

Skin Hydration
measure facial skin moisture level at pre-defined spots, with SkinFit instrument
Red Spot Count
measure the number of facial red spots at predefined areas, with SkinFit instrument
Red Vascular Count
measure the number of facial red vasculature at predefined areas, with SkinFit instrument
Porphyrin Count
measure the number of facial porphyrin at predefined areas, with SkinFit instrument
Wrinkles
measure the number of wrinkles and fine lines at predefined areas, with SkinFit instrument
Pores
measure the number of skin pores at predefined areas, with SkinFit instrument
Texture
measure the number of uneven skin textures, at predefined areas, with SkinFit instrument

Secondary Outcome Measures

Full Information

First Posted
July 12, 2022
Last Updated
July 25, 2022
Sponsor
4Life Research, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05476406
Brief Title
Clinical Study to Evaluate the Impact of aKwa Skincare System on Skin Health
Official Title
The Effects of äKwä Premium Skincare System on Improving Overall Skin Health and Beauty in Adults: An Exploratory Placebo-Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
July 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
4Life Research, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study was to evaluate the effectiveness of the äKwä 6-step skincare system by measuring skin moisture level, fine lines and wrinkles, porphyrin count, red spots, and red vasculature counts over a 30-day period.
Detailed Description
The äKwä 6-step skincare system is comprised of various skincare products intended to be applied both morning and night. Some of the notable ingredients included in the product formulas are fermented green tea water, other ferments, niacinamide, antioxidants, and a variety of natural plant extracts. The purpose of the study was to evaluate the effectiveness of the äKwä 6-step skincare system by measuring skin moisture level, fine lines and wrinkles, porphyrin count, red spots, and red vasculature counts over a 30-day period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sin Health, Skin Hydration, Skin Wrinkles, Skin Porphyrins, Facial Skin Red Spots, Facial Skin Red Vasculature

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One Active group and one Control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
äKwä Group
Arm Type
Experimental
Arm Description
participants use äKwä products daily as instructed for 30 days
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
participants use a competitor products daily as instructed for 30 days
Intervention Type
Other
Intervention Name(s)
äKwä skincare system products
Intervention Description
The skincare product system tested in this study was äKwä 6-step skincare system from 4Life Research USA, LLC ( https://www.4life.com/6613461/page/äKwä). Product directions state to use the following products morning and night in sequential order: First Wave Oil-to-Foam Cleanser, Glacier Glow Four-Way Toner, Precious Pool Vitamin Essence, Ripple Refine Eye Cream, and RainBurst Moisture Cream.
Intervention Type
Other
Intervention Name(s)
competitor products (control)
Intervention Description
Participants use whatever their normal daily routine of skincare products, which are commercially available competitor products from the marketplace.
Primary Outcome Measure Information:
Title
Skin Hydration
Description
measure facial skin moisture level at pre-defined spots, with SkinFit instrument
Time Frame
30 days
Title
Red Spot Count
Description
measure the number of facial red spots at predefined areas, with SkinFit instrument
Time Frame
30 days
Title
Red Vascular Count
Description
measure the number of facial red vasculature at predefined areas, with SkinFit instrument
Time Frame
30 days
Title
Porphyrin Count
Description
measure the number of facial porphyrin at predefined areas, with SkinFit instrument
Time Frame
30 days
Title
Wrinkles
Description
measure the number of wrinkles and fine lines at predefined areas, with SkinFit instrument
Time Frame
30 days
Title
Pores
Description
measure the number of skin pores at predefined areas, with SkinFit instrument
Time Frame
30 days
Title
Texture
Description
measure the number of uneven skin textures, at predefined areas, with SkinFit instrument
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals could participate who were at least 18 years old and in good health. Exclusion Criteria: had allergies or contraindications to any ingredient of products, had a history of any acute or chronic disease that could interfere with or increase the risk of study participation had any medical procedures, such as laser resurfacing, or plastic surgery to the test sites within the last 12 months (including Botox, Restylyn, or other fillers) chronic skin allergies (dermatitis, eczema, psoriasis) had been treated for skin cancer within the last 12 months or have damaged skin near the facial area (e.g., sunburn, tattoos, scars, or other disfigurations) pregnant or planning to become pregnant in the following 12 weeks, or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Vollmer, PhD
Organizational Affiliation
4LIFE
Official's Role
Study Chair
Facility Information:
Facility Name
4Life Research
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Study to Evaluate the Impact of aKwa Skincare System on Skin Health

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