A 16-week Clinical Study Investigating a Dark Spot Corrector Serum in Women With Moderate Discrete Hyperpigmentation

A Single-Center, Randomized, Double-Blind, Controlled Clinical Study to Assess a Targeted Dark Spot Treatment Alongside 2 Different Skincare Regimens

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.

Inclusion Criteria:

2. In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.

3. Having Fitzpatrick skin type I-IV (refer to Appendix I: Fitzpatrick Skin Type).

4. Having moderate (score of 4-6 according to a modified Griffiths scale,1 where 0=none and 9=severe) discrete hyperpigmentation (solar lentigines [age spots/sun spots]) on the global face.

5. Having at least 1 dark spot (solar lentigo [age spot or sun spot]) with moderate intensity (score 4-6) on each side of the face (with no more 0.5 point difference between scores on each side of the face) that is at least 3 mm in size and clearly discernible by the clinical grader and visible in all images at baseline to be tracked as target spots during the study.

6. Self-perceived very bothersome hyperpigmentation (darkening), including spots, on the global face.

Exclusion Criteria:

1. Having been diagnosed with known allergies to skin care products.
2. Having a known reactivity to niacinamide, sunflower seed, coconut, rosemary, barley, goji, sandalwood, licorice root, radish root, beeswax, and/or yeast.
3. Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
4. Having a history of skin cancer within the past 5 years.
5. Currently using oral or topical prescription medications for acne such as doxycycline, minocycline, clindamycin, Bactrim, tetracycline, erythromycin, azelaic acid, benzoyl peroxide, Dapsone, or sodium sulfacetamide.