Evaluation of the Safety and Tolerability of a Brightening Treatment Paired With a Skincare Regimen

Revision Skincare

Status: Completed

Conditions: Skin Roughness; Post Inflammatory Hyperpigmentation; Hyperpigmentation; Skin Ageing

Treatments: Other: Brightening Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT07501000

RS-2024-05

Details and patient eligibility

About

A12-week single-center, open-label, clinical study is being conducted to assess the efficacy and tolerability of the Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global facial pigmentation due to sun exposure, blemishes, and/or procedures when applied by a clinician in a series of 4 sessions at 2-week intervals. The procedure in this clinical study will include the brightening treatment, retinol serum, and a post-procedure cream. The study visits include baseline, week 2, 6, and 12.

Full description

A 12-week, single-center, open-label, clinical case study evaluating the efficacy and tolerability of a Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global face pigmentation when applied by a clinician in a series of 4 sessions at 2-week intervals.

At Visit 1 (Screening, Day -7), subjects will review and sign an Informed Consent Form (ICF) and photography release form. Subjects will then be screened for eligibility, and qualified subjects will commence a 7-day pre-treatment skincare regimen and be scheduled for the baseline visit. Subjects will be provided with the Gentle Foaming Cleanser, Vitamin C Serum, and a Broad-Spectrum Sunscreen SPF 50 to be used for the 7-day pre-treatment skincare regimen period along with skincare regimen instructions. Clinical assessments will be performed including Investigator Clinical Efficacy Grading, Investigator Tolerability Grading, Subject Tolerability Grading, VISIA®-CR or Apple iPad Imaging, Antera® Imaging, and Self-Assessment Questionnaires.

At Visit 2 (Baseline, Day 0) if subjects continue to meet eligibility, then subjects will receive their 1st Brightening Treatment (3 layers). At Visits 3, 4, and 5 (weeks 2, 4 and 6), subjects will return to the clinical site to receive 2nd, 3rd, and 4th Brightening Treatment (4, 5, and 5 layers, respectively). Various assessments will be performed before and after the procedure and will include Investigator Clinical Efficacy Grading, Investigator Tolerability Grading, Subject Tolerability Grading, Subject Sensitivity Grading, Investigator Skin Frosting Evaluation, VISIA®-CR Imaging, Antera® Imaging, and Self-Assessment Questionnaires. At Visit 2, subjects will be provided with a Post Procedure Cream to use on Days 0, 1, and 2 post treatment. Subjects will continue to use Gentle Foaming Cleanser, Vitamin C Serum (starting on day 3), and Broad-Spectrum Sunscreen SPF 50 as the post-treatment skincare regimen. Subjects will be provided with skincare regimen instructions to be followed throughout the 12-week clinical study. To confirm compliance with usage, each container will be weighed on a scale at every visit and subjects will record topical usage in a daily diary.

At Visit 6 (week 12), subjects will return to the clinical site for follow-up clinical evaluations. The same assessments completed at previous visits will be repeated.

Enrollment: 11 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Individuals in good general health (physical, mental, social well-being; not merely the absence of disease), based on medical history reported by the subject.
2. Individuals of Female biological sex.
3. Individuals between 20 to 65 years of age.
4. Individuals with Fitzpatrick skin types I - VI
5. Individuals of any race or ethnicity.
6. Individuals with moderate global facial Hyperpigmentation (score of 3 for darkness, and heterogeneity, and a score of 3 to 4 for area on the PIHASI scale).
7. Individuals with self-perceived facial pigmentation.

Exclusion criteria

1. Individuals currently participating in or has participated in any other clinical study involving the face at another research facility or doctor's office within the past one (1) month.
2. Individuals with no self-perceived facial pigmentation.
3. Individuals diagnosed with known allergies to facial skin care products, moisturizers, or sunscreens.
4. Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study according to subject self-report.
5. Individuals who currently smoke or have smoked (cigarette, e-cigarettes, etc.) within the past 5 years.
6. Individuals currently having or have a history of facial skin cancer within the past 5 years. Have or had cancer pertaining to any parts of the body and systems which in the opinion of the Investigator could interfere with the outcome of the study.
7. Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Skincare Regimen

Experimental group

Description:

7 day washout period skincare regimen: \- Gentle foaming Cleanser twice daily, vitamin C serum twice daily, and Broad-Spectrum Sunscreen SPF 50 once daily. 12-Week skincare regimen: Subjects will be provided with a Gentle Foaming Cleanser, Post Procedure Cream, Vitamin C Serum, and a Broad-Spectrum sunscreen SPF 50 for at home use. * Gentle Foaming Cleanser will be instructed to be used twice daily. * Post Procedure Cream will be instructed to be used twice daily on days 0, 1, and 2 post treatment. * Vitamin C Serum will be instructed to be used twice daily starting on Day 3 post treatment until the next clinic study visit. * Sunscreen SPF 50 will be used after application as the last step in the skin care regimen in the morning. Sunscreen to be reapplied if continuous sun exposure occurs.

Treatment:

Other: Brightening Treatment