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

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.

Study Overview

• Status: Completed
• Conditions: Photoaging; Anti-aging
• Intervention / Treatment: Other: Sunscreen Moisturizer; Other: Gentle Cleansing Lotion; Other: Facial Moisturizer

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Newtown Square, Pennsylvania, United States, 19073
      • Skin Study Center, KGL LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women between the ages of 35 and 60 years
• Women with Fitzpatrick skin type I-VI
• Subjects must have moderate to severe overall facial photodamage
• Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
• Subjects must be willing to provide verbal understanding and written informed consent.

Exclusion Criteria:

• Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients in the study product(s).
• Subjects who are currently under a physician's care for a medical problem that, in the opinion of the Investigator or his designee, could affect the subject's treatment response.
• Subjects who are nursing, pregnant, or planning a pregnancy during this study
• Subjects who have a health condition and/or pre-existing or dormant dermatologic disease on the face
• Subjects who are not willing to avoid daily sun exposure on their face and the use of tanning beds or sunless tanning products during the duration of the study.
• Is currently taking or have taken within the listed time frame prior to the start of the study: Oral isotretinoin (Accutane®) within the last 6 months; Avita®, Differin®, Renova®, Retin-A®, Retin-A Micro®, Soriatane®, or Tazorac® within 3 months; Prescription-strength skin-lightening products within 4 months; Any anti-wrinkle, skin-lightening, or other product or topical or systemic medication known to affect skin aging or dyschromia within 2 weeks; Had a non-ablative laser (Including IPL) or non-ablative fractional laser resurfacing of the face and neck within 6 months
• Has any other condition that, in the opinion of the Investigator or his designee, could interfere with the subject's ability to use the treatment as instructed, alter treatment response, or affect their ability to complete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single-Cell	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Clinical Efficacy Parameters at weeks 4, 8, and 12 versus Baseline	The primary efficacy endpoint will be Investigator Clinical Grading using a Modified Griffiths' 10-point scale. The scale ranges from 0 = none (best possible condition) to 9 = severe (worst possible condition). A decrease in score at post-baseline timepoints compared to baseline indicates an improvement. The parameters are fine lines (global face), wrinkles (global face), global hyperpigmentation (mottled and discrete), skin roughness (tactile), skin tone evenness (uniformity of skin color), overall photodamage, radiance (perceived glow), and skin firmness (tactile).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lack of significant increase in Objective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline	The primary tolerability endpoint will be the Investigator Tolerability Assessment of erythema, edema, and scaling/peeling of the face and neck. The 4-point scale ranges from 0 = none to 3 = severe. A decrease in score at post-baseline timepoints compared to baseline indicates an improvement.	12 weeks
Lack of significant increase in Subjective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline	The secondary tolerability endpoint will be the Subjective Tolerability Assessment of burning/stinging, itching, and tightness/dryness of the face and neck. The 4-point scale ranges from 0 = none to 3 = severe. A decrease in score at post-baseline timepoints compared to baseline indicates an improvement.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Assessment Questionnaire	The secondary efficacy endpoints will be the Self-Assessment Questionnaire on product efficacy and aesthetics. The 5-point scale ranges from 1 = completely disagree to 5 = completely agree. An increase in score at post-baseline timepoints compared to baseline indicates an improvement.	12 weeks
Improvement in skin density at weeks 4, 8, and 12 compared to Baseline	Ultrasound imaging of the left cheek will be used to measure skin density. An increase in value at post-baseline timepoints compared to baseline indicates an improvement.	12 weeks
Improvement in skin thickness at weeks 4, 8, and 12 compared to baseline.	Ultrasound imaging of the left cheek will be used to measure skin thickness. An increase in value at post-baseline timepoints compared to baseline indicates an improvement.	12 weeks
Improvement in skin hydration at weeks 4, 8, and 12 compared to Baseline	Corneometer measurements of the left cheek will be used to measure hydration content of the skin. An increase in value at post-baseline timepoints compared to baseline indicates an improvement.	12 weeks

Collaborators and Investigators

• Sponsor: Revision Skincare

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: 8674

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No