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

The Effects of äKwä Premium Skincare System on Improving Overall Skin Health and Beauty in Adults: An Exploratory Placebo-Controlled Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Sin Health; Skin Hydration; Skin Wrinkles; Skin Porphyrins; Facial Skin Red Spots; Facial Skin Red Vasculature
• Intervention / Treatment: Other: äKwä skincare system products; Other: competitor products (control)

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Sandy, Utah, United States, 84070
      • 4Life Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: äKwä Group; participants use äKwä products daily as instructed for 30 days	Other: äKwä skincare system products; 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.
Active Comparator: Control Group; participants use a competitor products daily as instructed for 30 days	Other: competitor products (control); Participants use whatever their normal daily routine of skincare products, which are commercially available competitor products from the marketplace.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Hydration	measure facial skin moisture level at pre-defined spots, with SkinFit instrument	30 days
Red Spot Count	measure the number of facial red spots at predefined areas, with SkinFit instrument	30 days
Red Vascular Count	measure the number of facial red vasculature at predefined areas, with SkinFit instrument	30 days
Porphyrin Count	measure the number of facial porphyrin at predefined areas, with SkinFit instrument	30 days
Wrinkles	measure the number of wrinkles and fine lines at predefined areas, with SkinFit instrument	30 days
Pores	measure the number of skin pores at predefined areas, with SkinFit instrument	30 days
Texture	measure the number of uneven skin textures, at predefined areas, with SkinFit instrument	30 days

Collaborators and Investigators

• Sponsor: 4Life Research, LLC
• Investigators: Study Chair: David Vollmer, PhD, 4LIFE

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): July 26, 2019

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Skin Manifestations; Erythema; Facies
• Other Study ID Numbers: RSC-017-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No