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

Sponsor

4Life Research, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT05476406

Collaborator

(none)

Enrollment

Location

Arms

3.5

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sin Health Skin Hydration Skin Wrinkles Skin Porphyrins Facial Skin Red Spots Facial Skin Red Vasculature	Other: äKwä skincare system products Other: competitor products (control)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

One Active group and one Control groupOne Active group and one Control group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 11, 2019

Actual Primary Completion Date :

May 30, 2019

Actual Study Completion Date :

Jul 26, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	4Life Research	Sandy	Utah	United States	84070

Sponsors and Collaborators

4Life Research, LLC

Investigators

Study Chair: David Vollmer, PhD, 4LIFE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

4Life Research, LLC

ClinicalTrials.gov Identifier:

NCT05476406

Other Study ID Numbers:

RSC-017-00

First Posted:

Jul 27, 2022

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Erythema

Facies

Study Results

No Results Posted as of Jul 27, 2022