This was a single-center, double-blinded, randomized, controlled cosmetic clinical trial to investigate the efficacy and tolerance of dark spot corrector serum and regimen skincare products when used over the course of 16 weeks by women with clinically determined moderate discrete hyperpigmentation (solar lentigines \[age spots/sun spots\]) on the global face, and self-perceived very bothersome hyperpigmentation (darkening), including spots, on the global face.
This was a single-center, double-blinded, randomized, controlled cosmetic clinical trial to investigate the efficacy and tolerance of dark spot corrector serum and regimen skincare products when used over the course of 12 weeks (spot treatment applied twice daily) and an additional 4-week maintenance period (spot treatment applied once daily) by women with clinically determined moderate discrete hyperpigmentation (solar lentigines \[age spots/sun spots\]) on the global face, and self-perceived very bothersome hyperpigmentation (darkening), including spots, on the global face. Subjects were randomized to either the basic skincare regimen or the enhanced skincare regimen. Both cells tested the dark spot corrector serum. This is a new hydroquinone-free serum formulated to address hyperpigmentation (melasma, solar lentigines, post-inflammatory hyperpigmentation). The basic regimen comprised of the basic gentle foaming cleanser, the dark spot corrector serum, a basic moisturizer and sunscreen. The enhanced skincare regimen comprised of the sponsors skincare products including a 0.25% retinol night cream, a 30% vitamin C serum, and a tinted sunscreen moisturizer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
The dark spot correcting serum is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
SGS Dallas Research Center
Richardson, Texas, United States
Measurement of Clinical Efficacy Parameters by Clinical Grader
Clinical grading efficacy parameters measured by blinded clinical grader including skin tone evenness and discrete hyperpigmentation (age spots/sun spots) on the global face; and for dark spot intensity (visual), dark spot size (visual), and dark spot appearance on each target dark spot. Grading was performed on a 10-point Griffith's scale, where 0 = best possible outcome 9= severe skin condition. A decrease in score/ value indicates an improvement.
Time frame: Baseline, week 2, 4, 8, 12, and 16
Incidence of Treatment- Emergent Adverse Events
Local cutaneous tolerability was evaluated by assessing the signs and symptoms of the following objective and subjective irritation parameters globally on each subject's face. Objective irritation (clinically graded): erythema, edema, and dryness. Subjective irritation (assessed by subjects): burning, stinging, and itching. Local cutaneous tolerability was evaluated by assessing objective (erythema, edema, and dryness) and subjective (burning, stinging, and itching) irritation parameters globally on each subject's face using a 4-point scale (0 = none to 3 = severe). A decrease in value indicates an improvement.
Time frame: Baseline, week 2, 8, 12, 16
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