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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05813054
Other study ID # PJ-00106
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date May 5, 2023

Study information

Verified date March 2023
Source Bioiberica
Contact PATRICIA GALVEZ
Phone 619515110
Email pgalvez@bioiberica.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 5, 2023
Est. primary completion date May 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 65 Years
Eligibility Inclusion Criteria: 1. Healthy women between 35 and 65 years of age (inclusive), showing signs of physiological facial skin aging. 2. Women willing not to use any firming product, skin lightening, or any other topical or systemic medication known to affect skin aging or dyschromia during the study period. 3. Be informed of the nature of the study and give their IC in writing. 4. Women willing not to become pregnant during the course of the study, using contraceptive methods considered highly effective. Exclusion Criteria: 1. Women with allergies to the ingredients in the investigational product. 2. Women who have used a dietary or nutricosmetic supplement containing HA, or who have undergone Botox or HA infiltrations, in the last 6 months prior to signing the IC. 3. Women who have undergone: - Superficial or medium-deep chemical peels or dermabrasion within the 6 weeks prior to signing the IC or inclusion document. - Deep facial chemical peel, non-ablative laser or fractional laser resurfacing in the 12 months prior to signing the IC or inclusion document. - Facial plastic surgery or a laser ablative procedure for photoaging in the 12 months prior to signing the IC or inclusion document. 4. Suspected uncontrolled disease, such as diabetes mellitus (DM), arterial hypertension (HT), hyperthyroidism or hypothyroidism, renal failure or liver failure. 5. Women who have received a PRP (Platelet Rich Plasma) injection as a treatment for aesthetic purposes, in the 3 months prior to inclusion by signing the IC. 6. Women who do not wish, for whatever reason, to take the supplements in the study. 7. Known pregnancy or lactation. 8. Presence of inflammatory skin disease such as psoriasis, atopic dermatitis, rosacea, acne or hidradenitis suppurativa. 9. Presence of active malignant pathologies or premalignant skin lesions such as actinic keratoses. 10. Psychiatric disorder that is not managed or any other circumstance or pathology that prevents the participant from understanding and/or complying with the study procedures.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
HA matrix ingredient
1 capsule/day
Placebo
1 capsule/day

Locations

Country Name City State
Spain Hospital Virgen de las Nieves Granada

Sponsors (1)

Lead Sponsor Collaborator
Bioiberica

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Skin Moisture The changes in the hydration of the facial stratum corneum using the Corneometer® CM825 measuring device, range: 0-130 arbitrary units Day 0, 12 week
Secondary 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 Day 0, 6 week, 12 week
Secondary Skin elasticity The changes of skin elasticity by Cutometer ® Dual MPA 580 probe, range: 0-100%. Day 0, 6 week, 12 week
Secondary Skin hardness The changes of Skin hardness by PCE-DDO 10 Durometer probe, range: 0-100 Shore O. Day 0, 6 week, 12 week
Secondary 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). Day 0, 6 week, 12 week
Secondary Skin pH The changes of skin pH by Skin-pH-Meter®PH905 probe, range: pH0 (acidic) - pH12 (alkaline). Day 0, 6 week, 12 week
Secondary Skin temperature The changes of the skin temperature by Skin-Thermometer ST500 probe, range: 15°C-40°C. Day 0, 6 week, 12 week
Secondary 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. Day 0, 6 week, 12 week
Secondary 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 . Day 0, 6 week, 12 week
Secondary Skin stiffness/deformability The changes of the stiffness/deformability by Indentometer IDM 800 probe, range: 0.00-3.00 millimeters. Day 0, 6 week, 12 week
Secondary Skin friction The changes of the skin friction by Frictiometer FR-700, range: 0-30 arbitrary units . Day 0, 6 week, 12 week
Secondary Skin radiance The changes of the skin radiance by Skin-Glossymeter GL 200 probe, range: 0-100 arbitrary units. Day 0, 6 week, 12 week
Secondary 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) Day 0, 6 week, 12 week
Secondary 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. Day 0, 6 week, 12 week
Secondary 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 Day 0, 12 week
Secondary Safety assessment Adverse events Day 0 to 12 week (anytime)
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