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

NCT ID: NCT06148558

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-09

Study Completion Date

2023-02-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Anti-aging Photoaging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single-Cell

Group Type OTHER

Sunscreen Moisturizer

Intervention Type OTHER

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

Gentle Cleansing Lotion

Intervention Type OTHER

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

Facial Moisturizer

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sunscreen Moisturizer

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

Intervention Type OTHER

Gentle Cleansing Lotion

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

Intervention Type OTHER

Facial Moisturizer

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Revision Skincare

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Skin Study Center, KGL LLC

Newtown Square, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

8674

Identifier Type: -

Identifier Source: org_study_id