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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anti-aging, Photoaging

Intervention / Treatment
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* Other: Sunscreen Moisturizer
* Other: Gentle Cleansing Lotion
* Other: Facial Moisturizer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label, 12-week study. 39 female subjects were recruited, 35 to 60 years, Fitzpatrick Skin Type I-VI, with moderate-severe overall facial photodamage.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single-Cell<br> | Other: Sunscreen Moisturizer<br>* A provided anti-aging sunscreen moisturizer SPF 50 was used once a day.<br>Other: Gentle Cleansing Lotion<br>* A provided Gentle Cleansing Lotion (Revision Skincare) was used 2x daily (AM/PM).<br>Other: Facial Moisturizer<br>* A provided facial moisturizer (Goodier) was used 1x daily (PM).<br>|

What is the study measuring?
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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 |