MATERIALS AND METHODS
An Institutional Review Board (IRB)-approved (Allendale Institutional Review Board, Old Lyme CT), open-label, historical control clinical study enrolled 50 subjects. All subjects possessed moderate to severe facial dyspigmentation. Upon study initiation, subjects were instructed to apply a topical formulation (ZO Skin Health Brightalive®) composed of a melanocyte sitespecific, cell-targeted technology twice daily over a 16-week period. The dermatologist investigator evaluated skin tone evening, brightening, and pigmentation reduction. Instrumental measures of skin pigmentation changes using colorimetry were also employed. Additionally, subjective self-assessments were compiled through a questionnaire.
After the initial screening visit, participants who consented to the study protocol replaced their usual cleanser and sunscreen with investigator-supplied study support products: a gentle, proprietary cleanser (ZO Skin Health Gentle Cleanser) and a sunscreen (ZO Skin Health Broad Spectrum Sunscreen SPF 50). Participants were further instructed to use the following daily skin treatment regimen during the 16-week treatment period:
• Gentle cleanser am and pm
• Cell-targeted Skin Brightening Treatment am and pm
• Broad Spectrum SPF 50 Sunscreen AM, reapplied every 2 hours throughout the day
• Colorimetry was used to objectively assess changes in skin: A chroma meter (Konica Minolta Sensing Americas, Inc.: Ramsey, NJ)
Additionally, all subjects answered a detailed questionnaire about their treatment perceptions at all follow-up visits.
A Mann-Whitney two-tailed paired test was used to analyze the nonparametric ordinal expert grading data and subjective questionnaires. Statistical significance was set at P<0.05.
After the initial screening visit, participants who consented to the study protocol replaced their usual cleanser and sunscreen with investigator-supplied study support products: a gentle, proprietary cleanser (ZO Skin Health Gentle Cleanser) and a sunscreen (ZO Skin Health Broad Spectrum Sunscreen SPF 50). Participants were further instructed to use the following daily skin treatment regimen during the 16-week treatment period:
• Gentle cleanser am and pm
• Cell-targeted Skin Brightening Treatment am and pm
• Broad Spectrum SPF 50 Sunscreen AM, reapplied every 2 hours throughout the day
• Colorimetry was used to objectively assess changes in skin: A chroma meter (Konica Minolta Sensing Americas, Inc.: Ramsey, NJ)
Additionally, all subjects answered a detailed questionnaire about their treatment perceptions at all follow-up visits.
A Mann-Whitney two-tailed paired test was used to analyze the nonparametric ordinal expert grading data and subjective questionnaires. Statistical significance was set at P<0.05.
RESULTS
Investigator
A total of 50 empaneled female subjects between 30 and 70 years completed the study. Investigator-graded dyspigmentation improvement parameters began to show statistically significant improvement starting at week 2, with continual improimprovement starting at week 2, with continual improvement over baseline at all follow-up visits (Table 1):
Instrumental
A Minolta Chroma Meter was used to measure differences in color lightness, chroma, and hue by utilizing the CIELAB mainstream color space coordinate system. Analysis of ΔE trends to measure cumulative changes in skin pigmentation affords the opportunity to validate the visually perceptible expert grading and self-assessment differences in skin pigmentation throughout the course of a clinical treatment program.
Experimentally verified statistics have determined that both experienced and unexperienced observers can see difference in color when ΔE exceeds 2.0.3 The ΔE values of >2.0 reported herein illustrate that noticeable and progressive cumulative changes in skin pigmentation were detectable that would be recognizable to both the experienced (expert grader) and inexperienced subjects, which is congruent with the expert visual grading and self-assessment data.
Subjective
Participants’ perceptions of the study product and its effects were highly favorable and statistically relevant. Consistent with the expert grading and colorimetry data, the panelist
A total of 50 empaneled female subjects between 30 and 70 years completed the study. Investigator-graded dyspigmentation improvement parameters began to show statistically significant improvement starting at week 2, with continual improimprovement starting at week 2, with continual improvement over baseline at all follow-up visits (Table 1):
Instrumental
A Minolta Chroma Meter was used to measure differences in color lightness, chroma, and hue by utilizing the CIELAB mainstream color space coordinate system. Analysis of ΔE trends to measure cumulative changes in skin pigmentation affords the opportunity to validate the visually perceptible expert grading and self-assessment differences in skin pigmentation throughout the course of a clinical treatment program.
Experimentally verified statistics have determined that both experienced and unexperienced observers can see difference in color when ΔE exceeds 2.0.3 The ΔE values of >2.0 reported herein illustrate that noticeable and progressive cumulative changes in skin pigmentation were detectable that would be recognizable to both the experienced (expert grader) and inexperienced subjects, which is congruent with the expert visual grading and self-assessment data.
Subjective
Participants’ perceptions of the study product and its effects were highly favorable and statistically relevant. Consistent with the expert grading and colorimetry data, the panelist
