Oral supplement with an HA matrix ingredient composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%) to evaluate the hydration of the stratum corneum of facial skin in healthy women showing natural signs of age-related aging versus placebo
This study includes 60 healthy volunteers in which will be evaluated if the oral supplement with Dermial \[composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%)\] is able to obtain differences versus placebo in healthy women showing natural signs of age-related aging versus placebo . It is a single-center, double-blind, randomized, placebo-controlled clinical study with proportion 1:1 between treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
60
1 capsule/day
1 capsule/day
Hospital Virgen de las Nieves
Granada, Spain
Skin Moisture
The changes in the hydration of the facial stratum corneum using the Corneometer® CM825 measuring device, range: 0-130 arbitrary units
Time frame: Day 0, 12 week
Skin Moisture
Evaluate changes in the hydration of the facial stratum corneum from baseline to 6 and 12 week by Corneometer® CM825 measuring device, range: 0-130 arbitrary units
Time frame: Day 0, 6 week, 12 week
Skin elasticity
The changes of skin elasticity by Cutometer ® Dual MPA 580 probe, range: 0-100%.
Time frame: Day 0, 6 week, 12 week
Skin hardness
The changes of Skin hardness by PCE-DDO 10 Durometer probe, range: 0-100 Shore O.
Time frame: Day 0, 6 week, 12 week
Skin Barrier
The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Tewameter® TM300 probe, range: 0-80 (g\*m-2\*h-1).
Time frame: Day 0, 6 week, 12 week
Skin pH
The changes of skin pH by Skin-pH-Meter®PH905 probe, range: pH0 (acidic) - pH12 (alkaline).
Time frame: Day 0, 6 week, 12 week
Skin temperature
The changes of the skin temperature by Skin-Thermometer ST500 probe, range: 15°C-40°C.
Time frame: Day 0, 6 week, 12 week
Antioxidant capacity of the skin
The total antioxidant capacity will be measured in microcoulombs, using conductive hydrogel strips designed for the direct measurement of antioxidant capacity using eBQC®, range: 0-20 microcoulombs.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 0, 6 week, 12 week
Erythema and skin melanin index
The erythema and melanin index will be measured in arbitrary units using the Mexameter® MX18 probe, range: 50-600 arbitrary units .
Time frame: Day 0, 6 week, 12 week
Skin stiffness/deformability
The changes of the stiffness/deformability by Indentometer IDM 800 probe, range: 0.00-3.00 millimeters.
Time frame: Day 0, 6 week, 12 week
Skin friction
The changes of the skin friction by Frictiometer FR-700, range: 0-30 arbitrary units .
Time frame: Day 0, 6 week, 12 week
Skin radiance
The changes of the skin radiance by Skin-Glossymeter GL 200 probe, range: 0-100 arbitrary units.
Time frame: Day 0, 6 week, 12 week
Facial Wrinkles and Fine lines of Crow's feet
Assessment of Reduction in Facial Wrinkles and Fine lines of Crow's feet area by VisioScan. It consists of a UV light camera and measures the skin surface profiles. (0-500 Rz)
Time frame: Day 0, 6 week, 12 week
Glogau Photodamage Scale
The change between the photodamage grade by dermatologist physical examination of treated area. The Glogau Photodamage Scale has a score from 1-4 (Type I: No wrinkles, Type II: Wrinkles in motion, Type III: Wrinkles at rest, Type IV: Only wrinkles), this scale represents a qualitative assessment to measure the severity of photodamage and wrinkles.
Time frame: Day 0, 6 week, 12 week
Satisfaction assessed
Level of satisfaction with the sensation of skin hydration, texture, luminosity and smoothness using a self-administered 5-point Likert scale of intensity ( 1\_Very dissatisfied; 2\_Dissatisfied; 3\_Neither satisfied nor dissatisfied; 4\_Satisfied; 5\_Very) satisfied
Time frame: Day 0, 12 week
Safety assessment
Adverse events
Time frame: Day 0 to 12 week (anytime)