NCT06148558

A Twelve Week Clinical Study to Evaluate the Efficacy and Tolerability of a Sunscreen Moisturizer SPF 50+

A Twelve Week Clinical Study to Evaluate the Efficacy and Tolerability of a Sunscreen Moisturizer SPF 50+ in Women With Moderate to Severe Overall Photodamage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Revision Skincare · Industry
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the efficacy and tolerance of a moisturizer SPF 50+ when used over a 12-week time period by women with moderate to severe facial photodamage.

Detailed description

This was a single center, single-cell, 12-week clinical trial on female subjects (Fitzpatrick Skin Type I-VI, evenly distributed) between 35-60 years of age with moderate to severe overall facial photodamage. All subjects were provided Revision Skincare Gentle Foaming Cleanser and Facial Moisturizer (Goodier Cosmetics) at the Screening visit after eligibility was confirmed. These products were used twice daily as instructed for a minimum 3 days prior to the Baseline visit (washout phase). At Baseline, subjects were given Sunscreen Moisturizer SPF 50+ to replace their Facial Moisturizer morning application. Subjects continued to use the Facial Moisturizer given at Screening in the evening. Clinical grading assessments, full face images, Corneometer, Ultrasound, and subject self-assessment questionnaires were completed at each study visit (Baseline, Week 4, 8, and 12). Full face images were also completed post-application at Baseline. A total of 34 subjects completed the study.

Conditions

• Anti-aging
• Photoaging

Interventions

Type	Name	Description
OTHER	Sunscreen Moisturizer	A provided anti-aging sunscreen moisturizer SPF 50 was used once a day.
OTHER	Gentle Cleansing Lotion	A provided Gentle Cleansing Lotion (Revision Skincare) was used 2x daily (AM/PM).
OTHER	Facial Moisturizer	A provided facial moisturizer (Goodier) was used 1x daily (PM).

Timeline

• Start date: 2022-11-09
• Primary completion: 2023-02-09
• Completion: 2023-02-09
• First posted: 2023-11-28
• Last updated: 2023-11-28

Locations

1 site across 1 country: United States