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.
Willing and able to comply with all study requirements and restrictions, provide informed consent, understand and complete study questionnaires, and undergo all study-related procedures.
Healthy women aged 35 to 65 years (inclusive) presenting signs of physiological facial skin ageing, defined as Grade II (Expression Wrinkles) or Grade III (Wrinkles at Rest) according to the Glogau Scale, as assessed by the investigator.
Body mass index (BMI) between 18.0 and 34.9 kg/m² (inclusive). Willingness to maintain their usual cosmetic treatment routine throughout the study.
Willingness to refrain from undergoing any facial rejuvenation treatments during the study.
Regular use of hyaluronic acid-containing creams within the 3 months prior to enrolment.
Regular use of oral supplements that may affect skin condition within the 3 months prior to enrolment.
Changes in facial or body cosmetic routines within 1 month prior to enrolment.
Use of medications affecting skin responses (e.g., glucocorticoids, antihistamines, immunomodulators).
Parallel
DERMIAL
Dietary supplement1 cap 60 mg/day
Placebo
Other interventionPlacebo
Change 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.
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.
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.
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.
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.
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Bioiberica
Lead sponsor
IMDA - Instituto de Medicina y Dermatología Avanzada
Collaborator
