ClinicalTrials.gg
Status unknownNCT05698485Updated Jul 25, 2023

The Effects of a 3-Part Skin Care Regimen on Facial Wrinkles and Biophysical Attributes

An interventional study of Cleansing Balm and Facial Serum in Wrinkle, sponsored by Integrative Skin Science and Research. Status unknown at 1 site in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-25.

Sponsored by Integrative Skin Science and Research · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2023), so the status shown — last known as Active, not recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
35 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to analyze various cosmetic endpoints, subjective assessments, and skin parameters such as hydration, transepidermal water loss, fine lines, and wrinkles with the use of a 3-part skin care regimen.

02

Conditions studied

  • Wrinkle
03

In context

Lead sponsor

Integrative Skin Science and Research is the lead sponsor of 35 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women between the ages of 35 years old and 65 years old.
  • Must have facial fine lines and wrinkles.

Exclusion criteria

Exclusion Criteria:

  • Individuals who are pregnant or breastfeeding.
  • Prisoners
  • Adults unable to consent
  • Individuals who have changed any of their hormonal based within 1 months prior to joining the study.
  • Subjects using any topical retinoid, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from prior to enrollment.
  • Subjects with any cosmetic 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    3 Step Skin Care Regimen

    3 different skin care products will be applied to the face

    Other: Cleansing Balm · Other: Facial Serum · Other: Moisturizer

Interventions

  • OtherCleansing Balm

    DermResults Cleansing Balm w/ Avocado Oil twice daily

  • OtherFacial Serum

    DermResults Advanced Serum w/ Hyaluronic Acid twice daily

  • OtherMoisturizer

    DermResults Advanced Moisturizer w/ Hyaluronic Acid twice daily

06

What researchers measure

Primary outcomes

  1. Appearance of facial wrinkles

    Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)

    Time frame: 8 weeks

Secondary outcomes

  1. Skin hydration

    Change in skin hydration by SkinMoistureMeterSC measurement

    Time frame: 1 week

  2. Skin hydration

    Change in skin hydration by SkinMoistureMeterSC measurement

    Time frame: 4 weeks

  3. Skin hydration

    Change in skin hydration by SkinMoistureMeterSC measurement

    Time frame: 8 weeks

  4. Transepidermal water loss

    Change in transepidermal water loss measurement by Vapometer

    Time frame: 1 week

  5. Transepidermal water loss

    Change in transepidermal water loss measurement by Vapometer

    Time frame: 4 weeks

  6. Transepidermal water loss

    Change in transepidermal water loss measurement by Vapometer

    Time frame: 8 weeks

  7. Skin volume

    Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System)

    Time frame: 1 week

  8. Skin volume

    Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System)

    Time frame: 4 weeks

  9. Skin volume

    Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System)

    Time frame: 8 weeks

  10. Skin texture/roughness

    Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System

    Time frame: 1 week

  11. Skin texture/roughness

    Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System

    Time frame: 4 weeks

  12. Skin texture/roughness

    Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System

    Time frame: 8 weeks

  13. Self-perception of skin parameters

    Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness

    Time frame: 1 week

  14. Self-perception of skin parameters

    Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness

    Time frame: 4 weeks

  15. Self-perception of skin parameters

    Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness

    Time frame: 8 weeks

  16. Tolerability of products

    Questionnaire based self-assessment about the tolerability of the topical skin products

    Time frame: 1 week

  17. Tolerability of products

    Questionnaire based self-assessment about the tolerability of the topical skin products

    Time frame: 4 weeks

  18. Tolerability of products

    Questionnaire based self-assessment about the tolerability of the topical skin products

    Time frame: 8 weeks

  19. Appearance of facial wrinkles

    Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)

    Time frame: 4 weeks

07

Study locations

1 site
  • Integrative Skin Science and Research
    Sacramento, California 95815, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2023 to primary completion in May 2023, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2023
First posted
Jan 26, 2023
StartActual
Feb 1, 2023
Primary completionActual
May 24, 2023
CompletionEst.
Dec 16, 2023
Last update
Jul 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05698485
Collaborators
Arbonne
Responsible party
Sponsor
First posted
Jan 26, 2023
Start date
Feb 1, 2023
Primary completion
May 24, 2023
Completion
Dec 16, 2023 (estimated)
Last update
Jul 25, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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