The present clinical study has been designed to evaluate the efficacy and safety of Dermial® at a daily dose of 60 mg on skin brightness, hydration, luminosity and other signs of facial skin aging in healthy women aged 35 to 65 years presenting physiological age-related skin aging, compared with placebo over a 12-week supplementation period.
This study is a randomized, double-blind, placebo-controlled, single-centre clinical trial designed to evaluate the effects of Dermial® on skin brightness and facial skin ageing in healthy women presenting physiological age-related skin ageing. A total of 146 healthy women aged 35 to 65 years will be enrolled and randomized in a 1:1 ratio to receive either Dermial® (60 mg/day) or placebo for a 12-week supplementation period. Eligible participants must present moderate signs of facial skin ageing, corresponding to Glogau Grade II or III, and meet predefined inclusion and exclusion criteria. The primary objective of the study is to assess the effect of Dermial® on facial skin brightness, measured in the right periocular area (crow's feet region) after 12 weeks of supplementation compared with placebo. Secondary objectives include the evaluation of skin brightness in additional facial areas, skin luminosity, stratum corneum hydration, skin pH, skin ageing parameters (wrinkles, roughness, scaling and smoothness), investigator-assessed facial ageing, participant self-assessment of facial appearance, overall product satisfaction, and product safety. Safety and tolerability will be evaluated throughout the study by monitoring adverse events and treatment compliance. Assessments will be performed at baseline, 3 weeks, 6 weeks and 12 weeks, including instrumental skin measurements, standardized facial photography, investigator evaluations and participant questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
146
Institute of Advanced Medicine and Dermatology (IMDA)
Madrid, Madrid, Spain
RECRUITINGChange in Facial Skin Glow
Facial skin gloss will be measured at the right periocular area using the Skin-Glossymeter® GL 200 probe. Skin gloss values will be expressed in arbitrary units (AU), with a measurement range of 0 to 100 AU. Results will be reported as the mean change from baseline to Week 12. Higher values indicate greater skin gloss.
Time frame: Baseline (week 0) to week 12 (primary analysis at week 12; assessments at weeks 3, 6 and 12)
Change in Skin Glow at Additional Facial Areas
Facial skin glow will be measured at the left periocular area and the right and left cheeks using the Skin-Glossymeter® GL 200 probe. Skin glow values will be expressed in arbitrary units (AU), with a measurement range of 0 to 100 AU. Results will be reported as the mean change from baseline at Weeks 3, 6, and 12. Higher values indicate greater skin glow.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Change in Facial Skin Radiance
Facial skin radiance will be measured at the right and left periocular areas and the right and left cheeks using the Colorimeter FLEX CL440 probe. Skin radiance values will be expressed in arbitrary units (AU), with a measurement range of 0 to 100 AU. Results will be reported as the mean change from baseline at Weeks 3, 6, and 12. Higher values indicate greater skin radiance.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Change in Facial Stratum Corneum Hydration
Facial stratum corneum hydration will be measured at the right and left periocular areas and the right and left cheeks using the Corneometer® CM825 probe. Hydration values will be expressed in arbitrary units (AU), with a measurement range of 0 to 130 AU. Results will be reported as the mean change from baseline at Weeks 3, 6, and 12. Higher values indicate greater stratum corneum hydration.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
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Change in Facial Skin pH
Facial skin pH will be measured at the right and left periocular areas and the right and left cheeks using the Skin-pH-Meter® PH905 probe. Skin pH values will be reported on the pH scale, with a measurement range from 0 (acidic) to 12 (alkaline). Results will be reported as the mean change from baseline at Weeks 3, 6, and 12.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Mean Change From Baseline in Facial Wrinkle (SEw)
Facial wrinkle severity will be assessed using the Visioscan® VC 20 PLUS. Results will be expressed as Surface Evaluation of Living Skin Wrinkle Parameter (SEw) values ranging from 0 to 500. Higher values indicate greater wrinkle severity. Results will be reported as the mean change from baseline at Weeks 3, 6, and 12.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Mean Change From Baseline in Facial Skin Smoothness (SEsm)
Facial skin smoothness will be assessed using the Visioscan® VC 20 PLUS. Results will be expressed as Surface Evaluation of Living Skin Smoothness Parameter (SEsm) values ranging from 0 to 500. Lower values indicate smoother skin and a better outcome. Results will be reported as the mean change from baseline at Weeks 3, 6, and 12.
Time frame: Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
Mean Change From Baseline in Facial Skin Roughness (SEr)
Facial skin roughness will be assessed using the Visioscan® VC 20 PLUS. Results will be expressed as Surface Evaluation of Living Skin Roughness Parameter (SEr) values ranging from 0 to 500. Higher values indicate greater skin roughness. Results will be reported as the mean change from baseline at Weeks 3, 6, and 12.
Time frame: Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
Mean Change From Baseline in Facial Skin Scaliness (SEsc)
Facial skin scaliness will be assessed using the Visioscan® VC 20 PLUS. Results will be expressed as Surface Evaluation of Living Skin Scaliness Parameter (SEsc) values ranging from 0 to 500. Higher values indicate greater skin scaliness. Results will be reported as the mean change from baseline at Weeks 3, 6, and 12.
Time frame: Baseline (Week 0) to Week 12 (assessments at Weeks 3, 6, and 12)
Change in Glogau Photodamage Scale Classification
The change in facial skin ageing severity assessed by investigator evaluation using the Glogau Photodamage Scale. The Glogau Photodamage Scale ranges from Type I (no wrinkles) to Type IV (severe photoaging with advanced wrinkling) and provides a qualitative assessment of photodamage and wrinkle severity. Results will be reported as the change from baseline in Glogau Photodamage Scale classification at Weeks 3, 6, and 12.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Change From Baseline in Global Aesthetic Improvement Scale (GAIS) Score
Facial appearance will be self-assessed using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from 1 (Much Worse) to 5 (Very Much Improved). Higher scores indicate greater perceived improvement in facial appearance. Results will be reported as the change from baseline in GAIS score at Weeks 3, 6, and 12.
Time frame: Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)
Participant Satisfaction With the Study Product Assessed by 5-Point Likert Scale
Participant satisfaction with the study product will be assessed at Week 12 using a 5-point Likert scale ranging from 1 (Very Dissatisfied) to 5 (Very Satisfied). Higher scores indicate greater satisfaction with the study product. Results will be reported as the participant satisfaction score at Week 12.
Time frame: Week 12
Number of Participants With Adverse Events
Adverse events (AEs) and serious adverse events (SAEs) reported from baseline through Week 12 will be recorded and summarized by treatment group. The incidence, severity, and relationship to the study product will be assessed by the investigator. The outcome will be reported as the number of participants experiencing at least one adverse event.
Time frame: Baseline (week 0) to week 12