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

Skin Hydration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05476406
• Other study ID #: RSC-017-00
• Status: Completed
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: July 26, 2019

Study information

• Verified date: July 2022
• Source: 4Life Research, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 26, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Erythema
• Facies
• Skin Hydration

Intervention

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.
• competitor products (control)
Participants use whatever their normal daily routine of skincare products, which are commercially available competitor products from the marketplace.

Locations

Country	Name	City	State
United States	4Life Research	Sandy	Utah

Sponsors (1)

Lead Sponsor	Collaborator
4Life Research, LLC

Country where clinical trial is conducted

United States, 

Outcome

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