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

NCT06148558 | Completed

• 1 other identifier: 8674
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Anti-aging; Photoaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Lack of significant increase in Objective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline

  12 weeks

• Lack of significant increase in Subjective Tolerability Parameters at weeks 4, 8, and 12 compared to Baseline

  12 weeks

Other Outcomes (4)

• Self-Assessment Questionnaire

  12 weeks

• Improvement in skin density at weeks 4, 8, and 12 compared to Baseline

  12 weeks

• Improvement in skin thickness at weeks 4, 8, and 12 compared to baseline.

  12 weeks

Study Arms (1)

Single-Cell

OTHER

Other: Sunscreen Moisturizer; Other: Gentle Cleansing Lotion; Other: Facial Moisturizer

Interventions

Sunscreen Moisturizer OTHER

A provided anti-aging sunscreen moisturizer SPF 50 was used once a day.

Single-Cell

Gentle Cleansing Lotion OTHER

A provided Gentle Cleansing Lotion (Revision Skincare) was used 2x daily (AM/PM).

Single-Cell

Facial Moisturizer OTHER

A provided facial moisturizer (Goodier) was used 1x daily (PM).

Single-Cell

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Revision Skincare: lead

Study Sites (1)

Skin Study Center, KGL LLC

Newtown Square, Pennsylvania, 19073, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 28, 2023
• Study Start: November 9, 2022
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

US (1)