Dark Spots, Hyperpigmentation
Conditions
Keywords
dark spot correction, cosmetic skincare, brightening regimen
Brief summary
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.
Detailed description
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.
Interventions
OTHERCosmetic dark spot corrector serum
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.
Sponsors
Revision Skincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
This was a double-blinded, single-center controlled study. The interventional study model was performed in parallel. Subjects were randomized either to the basic skincare regimen or the enhanced skincare regimen. Both experimental cells had the intervention, dark spot corrector serum. The objective was to review clinical parameters for both cells at post-baseline timepoints versus baseline AND to review the basic skincare regimen versus the enhanced skincare regimen.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Clinical Efficacy Parameters by Clinical Grader | Baseline, week 2, 4, 8, 12, and 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment- Emergent Adverse Events | Baseline, week 2, 8, 12, 16 | 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. |
Countries
United States
Outcome results
None listed