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

Not Applicable

Active, not recruiting

• Conditions: Wrinkle
• Interventions: Other: Cleansing Balm; Other: Facial Serum; Other: Moisturizer

• Registration Number: NCT05698485
• Lead Sponsor: Integrative Skin Science and Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-01-26
• Study Start: 2023-02-01
• Primary Completion: 2023-05-24
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25
• Study Completion: 2023-12-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3 Step Skin Care Regimen	Moisturizer	3 different skin care products will be applied to the face
3 Step Skin Care Regimen	Cleansing Balm	3 different skin care products will be applied to the face
3 Step Skin Care Regimen	Facial Serum	3 different skin care products will be applied to the face

Primary Outcome Measures

Name	Time	Method
Appearance of facial wrinkles	8 weeks	Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States