Clinical trial NCT06148558: A Twelve Week Clinical Study to Evaluate the Efficacy and Tolerability of a Sunscreen Moisturizer SPF 50+
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anti-aging
Photoaging
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 36
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Clinical Efficacy Parameters at weeks 4, 8, and 12 versus Baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Lack of significant increase in Objective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline
timeFrame: 12 weeks
measure: Lack of significant increase in Subjective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline
timeFrame: 12 weeks
Other outcomes:
measure: Self-Assessment Questionnaire
timeFrame: 12 weeks
measure: Improvement in skin density at weeks 4, 8, and 12 compared to Baseline
timeFrame: 12 weeks
measure: Improvement in skin thickness at weeks 4, 8, and 12 compared to baseline.
timeFrame: 12 weeks
measure: Improvement in skin hydration at weeks 4, 8, and 12 compared to Baseline
timeFrame: 12 weeks
Locations:
city: Newtown Square
country: United States
facility: Skin Study Center, KGL LLC
state: Pennsylvania
Study officials:
References: