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

NCT05476406 | Completed

• 1 other identifier: RSC-017-00
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Sin Health; Skin Hydration; Skin Wrinkles; Skin Porphyrins; Facial Skin Red Spots; Facial Skin Red Vasculature

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

äKwä Group

EXPERIMENTAL

participants use äKwä products daily as instructed for 30 days

Other: äKwä skincare system products

Control Group

ACTIVE COMPARATOR

participants use a competitor products daily as instructed for 30 days

Other: competitor products (control)

Interventions

äKwä skincare system products OTHER

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.

äKwä Group

competitor products (control) OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• 4Life Research, LLC: lead

Study Sites (1)

4Life Research

Sandy City, Utah, 84070, United States

Location

Study Officials

• David Vollmer, PhD

  4LIFE

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One Active group and one Control group

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 27, 2022
• Study Start: April 11, 2019
• Primary Completion: May 30, 2019
• Study Completion: July 26, 2019
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

US (1)