Clinical Study to Evaluate the Anti-aging Efficacy of Dermial® (DermiAge)

Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Anti-aging Efficacy of Dermial®

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

Study Overview

• Status: Recruiting
• Conditions: Skin Aging
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: HA matrix ingredient

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PATRICIA GALVEZ; Phone Number: 619515110; Email: pgalvez@bioiberica.com

Study Locations

• Spain
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Virgen de las Nieves
    • Contact: Salvador Arias; Phone Number: 958023465

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HA matrix ingredient; 1 cap/day	Dietary supplement: HA matrix ingredient; 1 capsule/day
Placebo Comparator: Placebo; 1 cap/day	Dietary supplement: Placebo; 1 capsule/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Skin elasticity	The changes of skin elasticity by Cutometer ® Dual MPA 580 probe, range: 0-100%.	Day 0, 6 week, 12 week
Skin hardness	The changes of Skin hardness by PCE-DDO 10 Durometer probe, range: 0-100 Shore O.	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).	Day 0, 6 week, 12 week
Skin pH	The changes of skin pH by Skin-pH-Meter®PH905 probe, range: pH0 (acidic) - pH12 (alkaline).	Day 0, 6 week, 12 week
Skin temperature	The changes of the skin temperature by Skin-Thermometer ST500 probe, range: 15°C-40°C.	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.	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 .	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.	Day 0, 6 week, 12 week
Skin friction	The changes of the skin friction by Frictiometer FR-700, range: 0-30 arbitrary units .	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.	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)	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.	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	Day 0, 12 week
Safety assessment	Adverse events	Day 0 to 12 week (anytime)

Collaborators and Investigators

• Sponsor: Bioiberica
• Investigators: Principal Investigator: Salvador Arias, Hospital Virgen de las Nieves (Granada)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): May 5, 2023
• Study Completion (Anticipated): May 5, 2023

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PJ-00106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No