Sin HealthNCT05476406
Clinical Study to Evaluate the Impact of aKwa Skincare System on Skin Health
A study testing äKwä skincare system products in people with Sin Health and Skin Hydration, run by 4Life Research, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sin Health, Skin Hydration, Skin Wrinkles
- What is being tested?
- äKwä skincare system products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to 26 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals could participate who were at least 18 years old and in good health.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sin Health, Skin Hydration, Skin Wrinkles, Skin Porphyrins, Facial Skin Red Spots, Facial Skin Red Vasculature
- Being tested
- äKwä skincare system products, competitor products (control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
äKwä skincare system productsOther
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)Other
Participants use whatever their normal daily routine of skincare products, which are commercially available competitor products from the marketplace.
| Study group | Role | What they receive |
|---|---|---|
| äKwä Group | Experimental | participants use äKwä products daily as instructed for 30 days Receives: Other: äKwä skincare system products |
| Control Group | Active comparator | participants use a competitor products daily as instructed for 30 days Receives: Other: competitor products (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Hydration
measure facial skin moisture level at pre-defined spots, with SkinFit instrument
Measured: 30 days
Red Spot Count
measure the number of facial red spots at predefined areas, with SkinFit instrument
Measured: 30 days
Red Vascular Count
measure the number of facial red vasculature at predefined areas, with SkinFit instrument
Measured: 30 days
Porphyrin Count
measure the number of facial porphyrin at predefined areas, with SkinFit instrument
Measured: 30 days
Wrinkles
measure the number of wrinkles and fine lines at predefined areas, with SkinFit instrument
Measured: 30 days
Pores
measure the number of skin pores at predefined areas, with SkinFit instrument
Measured: 30 days
Texture
measure the number of uneven skin textures, at predefined areas, with SkinFit instrument
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start11 Apr 2019
- Primary completion30 May 2019
- Study completion26 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sin HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One Active group and one Control group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4Life Research, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Vollmer, PhD, Study chair, 4LIFE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476406
- Sponsor's protocol ID
- RSC-017-00
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of äKwä Premium Skincare System on Improving Overall Skin Health and Beauty in Adults: An Exploratory Placebo-Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05476406
- Acronym / sponsor ID
- RSC-017-00
- Conditions
- Sin Health, Skin Hydration, Skin Wrinkles, Skin Porphyrins, Facial Skin Red Spots, Facial Skin Red Vasculature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- 4Life Research, LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One Active group and one Control group
| Arm | Type | Receives |
|---|---|---|
| äKwä Group | Experimental | Other: äKwä skincare system productsparticipants use äKwä products daily as instructed for 30 days |
| Control Group | Active comparator | Other: competitor products (control)participants use a competitor products daily as instructed for 30 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals could participate who were at least 18 years old and in good health.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| äKwä skincare system productsThe 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. | Other | äKwä Group |
| competitor products (control)Participants use whatever their normal daily routine of skincare products, which are commercially available competitor products from the marketplace. | Other | Control Group |
Primary outcome
Skin Hydration
Time frame: 30 days
measure facial skin moisture level at pre-defined spots, with SkinFit instrument
Red Spot Count
Time frame: 30 days
measure the number of facial red spots at predefined areas, with SkinFit instrument
Red Vascular Count
Time frame: 30 days
measure the number of facial red vasculature at predefined areas, with SkinFit instrument
Porphyrin Count
Time frame: 30 days
measure the number of facial porphyrin at predefined areas, with SkinFit instrument
Wrinkles
Time frame: 30 days
measure the number of wrinkles and fine lines at predefined areas, with SkinFit instrument
Pores
Time frame: 30 days
measure the number of skin pores at predefined areas, with SkinFit instrument
Texture
Time frame: 30 days
measure the number of uneven skin textures, at predefined areas, with SkinFit instrument
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
Related trials for Sin Health
Active, not recruiting
Health Without Barriers/Salud Sin Barreras- Northern Colorado
Lifestyle Risk Reduction, Adolescent Health
Recruiting
Health Without Barriers/Salud Sin Barreras
Mental Health Wellness, Family Research
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Vollmer, PhD study chair
4LIFE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing äKwä skincare system products in people with Sin Health and Skin Hydration, run by 4Life Research, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Hydration (time frame: 30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.