Hospital Virgen de las Nieves
Granada, 18014, Spain
NCT Number: NCT05813054
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
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Notify Me35 year–65 year
All sexes
Interventional
Not applicable
Granada, 18014, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 capsule/day
1 capsule/day
Time frame: Day 0, 12 week
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, 6 week, 12 week
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
The changes of skin elasticity by Cutometer ® Dual MPA 580 probe, range: 0-100%.
Time frame: Day 0, 6 week, 12 week
The changes of Skin hardness by PCE-DDO 10 Durometer probe, range: 0-100 Shore O.
Time frame: Day 0, 6 week, 12 week
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
The changes of skin pH by Skin-pH-Meter®PH905 probe, range: pH0 (acidic) - pH12 (alkaline).
Time frame: Day 0, 6 week, 12 week
The changes of the skin temperature by Skin-Thermometer ST500 probe, range: 15°C-40°C.
Time frame: Day 0, 6 week, 12 week
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.
Time frame: Day 0, 6 week, 12 week
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
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
The changes of the skin friction by Frictiometer FR-700, range: 0-30 arbitrary units .
Time frame: Day 0, 6 week, 12 week
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
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
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, 12 week
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 to 12 week (anytime)
Adverse events
Bioiberica
Industry
Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Anti-aging Efficacy of Dermial®
Acronym: DermiAge
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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