Clinical trial NCT05813054: Clinical Study to Evaluate the Anti-aging Efficacy of Dermial®
Official title: Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Anti-aging Efficacy of Dermial®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Lead sponsor: Bioiberica
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Skin Moisture
timeFrame: Day 0, 12 week
Secondary outcomes:
measure: Skin Moisture
timeFrame: Day 0, 6 week, 12 week
measure: Skin elasticity
timeFrame: Day 0, 6 week, 12 week
measure: Skin hardness
timeFrame: Day 0, 6 week, 12 week
measure: Skin Barrier
timeFrame: Day 0, 6 week, 12 week
measure: Skin pH
timeFrame: Day 0, 6 week, 12 week
measure: Skin temperature
timeFrame: Day 0, 6 week, 12 week
measure: Antioxidant capacity of the skin
timeFrame: Day 0, 6 week, 12 week
measure: Erythema and skin melanin index
timeFrame: Day 0, 6 week, 12 week
measure: Skin stiffness/deformability
timeFrame: Day 0, 6 week, 12 week
measure: Skin friction
timeFrame: Day 0, 6 week, 12 week
measure: Skin radiance
timeFrame: Day 0, 6 week, 12 week
measure: Facial Wrinkles and Fine lines of Crow's feet
timeFrame: Day 0, 6 week, 12 week
measure: Glogau Photodamage Scale
timeFrame: Day 0, 6 week, 12 week
measure: Satisfaction assessed
timeFrame: Day 0, 12 week
measure: Safety assessment
timeFrame: Day 0 to 12 week (anytime)
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
Study officials:
affiliation: Hospital Virgen de las Nieves (Granada)
name: Salvador Arias
role: PRINCIPAL_INVESTIGATOR
References: