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NCT05698485 Clinical Trial

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

Wrinkle Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05698485
Other study ID # ARB_SKIN3
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date December 16, 2023

Study information
Verified date July 2023
Source Integrative Skin Science and Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 36
Est. completion date December 16, 2023
Est. primary completion date May 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 65 Years
Eligibility 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: - Individuals who are pregnant or breastfeeding. - Prisoners - Adults unable to consent - Individuals who have changed any of their hormonal based contraception 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 washout 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Cleansing Balm
DermResults Cleansing Balm w/ Avocado Oil twice daily
• Facial Serum
DermResults Advanced Serum w/ Hyaluronic Acid twice daily
• Moisturizer
DermResults Advanced Moisturizer w/ Hyaluronic Acid twice daily

Locations
Country Name City State
United States Integrative Skin Science and Research Sacramento California

Sponsors (2)
Lead Sponsor Collaborator
Integrative Skin Science and Research Arbonne

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Appearance of facial wrinkles Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System) 8 weeks
Secondary Skin hydration Change in skin hydration by SkinMoistureMeterSC measurement 1 week
Secondary Skin hydration Change in skin hydration by SkinMoistureMeterSC measurement 4 weeks
Secondary Skin hydration Change in skin hydration by SkinMoistureMeterSC measurement 8 weeks
Secondary Transepidermal water loss Change in transepidermal water loss measurement by Vapometer 1 week
Secondary Transepidermal water loss Change in transepidermal water loss measurement by Vapometer 4 weeks
Secondary Transepidermal water loss Change in transepidermal water loss measurement by Vapometer 8 weeks
Secondary Skin volume Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System) 1 week
Secondary Skin volume Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System) 4 weeks
Secondary Skin volume Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System) 8 weeks
Secondary Skin texture/roughness Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System 1 week
Secondary Skin texture/roughness Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System 4 weeks
Secondary Skin texture/roughness Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System 8 weeks
Secondary Self-perception of skin parameters Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness 1 week
Secondary Self-perception of skin parameters Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness 4 weeks
Secondary Self-perception of skin parameters Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness 8 weeks
Secondary Tolerability of products Questionnaire based self-assessment about the tolerability of the topical skin products 1 week
Secondary Tolerability of products Questionnaire based self-assessment about the tolerability of the topical skin products 4 weeks
Secondary Tolerability of products Questionnaire based self-assessment about the tolerability of the topical skin products 8 weeks
Secondary Appearance of facial wrinkles Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System) 4 weeks
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