Evaluation of the Safety and Tolerability of a Brightening Treatment Paired With a Skincare Regimen (NCT07501000) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Safety and Tolerability of a Brightening Treatment Paired With a Skincare Regimen
United States11 participantsStarted 2024-10-07
Plain-language summary
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.
Who can participate
Age range20 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Individuals in good general health (physical, mental, social well-being; not merely the absence of disease), based on medical history reported by the subject.
✓. Individuals of Female biological sex.
✓. Individuals between 20 to 65 years of age.
✓. Individuals with Fitzpatrick skin types I - VI
✓. Individuals of any race or ethnicity.
✓. 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).
✓. Individuals with self-perceived facial pigmentation.
Exclusion criteria
✕. 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.
✕. Individuals with no self-perceived facial pigmentation.
✕. Individuals diagnosed with known allergies to facial skin care products, moisturizers, or sunscreens.
✕. Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study according to subject self-report.
✕. Individuals who currently smoke or have smoked (cigarette, e-cigarettes, etc.) within the past 5 years.
✕. 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.
✕. Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.