WrinkleNCT05688527
The Effects of a 5-Step Skin Regimen on Pigmentation and Appearance Related Biophysical Properties
A study testing Cleansing Balm, Toning Essence and Facial Serum in people with Wrinkle, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
This study is to analyze the effects of a 5-step skin care regimen on various skin parameters such as pigmentation, and firmness and elasticity of the skin around the eyes. The 5 facial products in the regimen are a cleansing balm, a toner, a serum, a moisturizer. and an eye cream. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Cleansing Balm, Toning Essence and Facial Serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2023to 16 Dec 2023
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 35 years old and 65 years old.
- Must have fine lines and wrinkles around the eyes.
Who cannot join
- Individuals who are pregnant or breastfeeding.
- Prisoners
- Adults unable to consent
- Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- Subjects using any topical retinoid, hydroquinone, kojic acid, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.
- Subjects with any facial treatments in the past 6 months and who are unwilling to withhold facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, tightening treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
- Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research
Sacramento, California, 95815
About this study
This study is to analyze the effects of a 5-step skin care regimen on various skin parameters such as pigmentation, and firmness and elasticity of the skin around the eyes. The 5 facial products in the regimen are a cleansing balm, a toner, a serum, a moisturizer. and an eye cream.
- Conditions
- Wrinkle
- Being tested
- Cleansing Balm, Toning Essence, Facial Serum, Moisturizer, Eye Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleansing BalmOther
DermResults Cleansing Balm w/ Avocado Oil twice daily
Toning EssenceOther
DermResults Advanced Toning Essence w/ Mineral Booster twice daily
Facial SerumOther
DermResults Advanced Serum w/ Hyaluronic Acid twice daily
MoisturizerOther
DermResults Advanced Moisturizer w/ Hyaluronic Acid twice daily
Eye CreamOther
DermResults Advanced Eye Cream w/ Hyaluronic Acid twice daily
| Study group | Role | What they receive |
|---|---|---|
| 5 Step Skin Care Regimen | Experimental | The subject uses 5 facial products in the regimen; a cleansing balm, a toner, a serum, a moisturizer and an eye cream. Receives: Other: Cleansing Balm; Other: Toning Essence; Other: Facial Serum; Other: Moisturizer; Other: Eye Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of facial wrinkles
Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)
Measured: 8 weeks
Change in skin pigmentation in the undereye area
Change in skin pigmentation in the undereye area by Skin colorimetric analysis of pigment
Measured: 8 weeks
Secondary outcomes (19)
Skin hydration
Change in skin hydration by SkinMoistureMeterSC measurement
Measured: 1 week
Skin hydration
Change in skin hydration by SkinMoistureMeterSC measurement
Measured: 4 weeks
Skin hydration
Change in skin hydration by SkinMoistureMeterSC measurement
Measured: 8 weeks
Transepidermal water loss
Change in transepidermal water loss measurement with Vapometer
Measured: 1 week
Transepidermal water loss
Change in transepidermal water loss measurement with Vapometer
Measured: 4 weeks
Transepidermal water loss
Change in transepidermal water loss measurement with Vapometer
Measured: 8 weeks
Skin volume
Change in skin volume/plumpness by photographic image analysis with BTBP 3D Camera System
Measured: 1 week
Skin volume
Change in skin volume/plumpness by photographic image analysis with BTBP 3D Camera System
Measured: 4 weeks
Skin volume
Change in skin volume/plumpness by photographic image analysis with BTBP 3D Camera System
Measured: 8 weeks
Skin texture/roughness
Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System
Measured: 1 week
Skin texture/roughness
Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System
Measured: 4 weeks
Skin texture/roughness
Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System
Measured: 8 weeks
Self-perception of skin parameters
Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness
Measured: 1 week
Self-perception of skin parameters
Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness
Measured: 4 weeks
Self-perception of skin parameters
Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness
Measured: 8 weeks
Tolerability of products
Questionnaire based self-assessment about the tolerability of the topical skin products
Measured: 1 week
Tolerability of products
Questionnaire based self-assessment about the tolerability of the topical skin products
Measured: 4 weeks
Tolerability of products
Questionnaire based self-assessment about the tolerability of the topical skin products
Measured: 8 weeks
Appearance of facial wrinkles
4 weeks
Measured: Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start23 Jan 2023
- Primary completion16 May 2023
- Study completion16 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arbonne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688527
- Sponsor's protocol ID
- ARB_SKIN5
- Status last verified
- Jul 2023
- First submitted
- 5 Jan 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a 5-Step Skin Regimen on Pigmentation and Appearance Related Biophysical Properties
- ClinicalTrials.gov ID
- NCT05688527
- Acronym / sponsor ID
- ARB_SKIN5
- Conditions
- Wrinkle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Arbonne
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 Dec 2023 (estimated)
- First posted
- 18 Jan 2023 (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.
This study is to analyze the effects of a 5-step skin care regimen on various skin parameters such as pigmentation, and firmness and elasticity of the skin around the eyes. The 5 facial products in the regimen are a cleansing balm, a toner, a serum, a moisturizer. and an eye cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5 Step Skin Care Regimen | Experimental | Other: Cleansing Balm, Other: Toning Essence, Other: Facial Serum, Other: Moisturizer, Other: Eye CreamThe subject uses 5 facial products in the regimen; a cleansing balm, a toner, a serum, a moisturizer and an eye cream. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women between the ages of 35 years old and 65 years old.
- Must have fine lines and wrinkles around the eyes.
Key exclusion criteria (7 listed)
- Individuals who are pregnant or breastfeeding.
- Prisoners
- Adults unable to consent
- Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- Subjects using any topical retinoid, hydroquinone, kojic acid, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.
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 |
|---|---|---|
| Cleansing BalmDermResults Cleansing Balm w/ Avocado Oil twice daily | Other | 5 Step Skin Care Regimen |
| Toning EssenceDermResults Advanced Toning Essence w/ Mineral Booster twice daily | Other | 5 Step Skin Care Regimen |
| Facial SerumDermResults Advanced Serum w/ Hyaluronic Acid twice daily | Other | 5 Step Skin Care Regimen |
| MoisturizerDermResults Advanced Moisturizer w/ Hyaluronic Acid twice daily | Other | 5 Step Skin Care Regimen |
| Eye CreamDermResults Advanced Eye Cream w/ Hyaluronic Acid twice daily | Other | 5 Step Skin Care Regimen |
Primary outcome
Appearance of facial wrinkles
Time frame: 8 weeks
Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)
Change in skin pigmentation in the undereye area
Time frame: 8 weeks
Change in skin pigmentation in the undereye area by Skin colorimetric analysis of pigment
19 secondary outcomes
Skin hydration
Time frame: 1 week
Skin hydration
Time frame: 4 weeks
Skin hydration
Time frame: 8 weeks
Transepidermal water loss
Time frame: 1 week
Transepidermal water loss
Time frame: 4 weeks
Transepidermal water loss
Time frame: 8 weeks
Skin volume
Time frame: 1 week
Skin volume
Time frame: 4 weeks
Skin volume
Time frame: 8 weeks
Skin texture/roughness
Time frame: 1 week
Skin texture/roughness
Time frame: 4 weeks
Skin texture/roughness
Time frame: 8 weeks
Self-perception of skin parameters
Time frame: 1 week
Self-perception of skin parameters
Time frame: 4 weeks
Self-perception of skin parameters
Time frame: 8 weeks
Tolerability of products
Time frame: 1 week
Tolerability of products
Time frame: 4 weeks
Tolerability of products
Time frame: 8 weeks
Appearance of facial wrinkles
Time frame: Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Wrinkle
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleansing Balm, Toning Essence and Facial Serum in people with Wrinkle, run by Integrative Skin Science and Research 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. 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?
Results are not available in the source record.
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?
Appearance of facial wrinkles (time frame: 8 weeks). The study lists 2 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 25 Jul 2023.