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

Bioiberica

Status: Completed

Conditions: Skin Aging

Treatments: Dietary Supplement: Placebo; Dietary Supplement: HA matrix ingredient

Study type: Interventional

Funder types: Industry

Identifiers

NCT05813054

PJ-00106

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

HA matrix ingredient

Experimental group

Description:

1 cap/day

Treatment:

Dietary Supplement: HA matrix ingredient

Placebo

Placebo Comparator group

Description:

1 cap/day

Treatment:

Dietary Supplement: Placebo