Clinical Study to Evaluate the Anti-aging Efficacy and Skin Radiance-enhancing Effect of Dermial®.

NCT07790237 | Active Not Recruiting

• 1 other identifier: PJ-0188
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The present clinical study has been designed to evaluate the efficacy and safety of Dermial® at a daily dose of 60 mg on skin brightness, hydration, luminosity and other signs of facial skin aging in healthy women aged 35 to 65 years presenting physiological age-related skin aging, compared with placebo over a 12-week supplementation period.

Conditions

Healthy Adult Females

Keywords

Dermial®; Hyaluronic Acid Matrix; Skin Glow; Skin Radiance; Skin Brightness; Facial Skin Ageing; Skin Hydration; Wrinkle Reduction; Nutricosmetics; Skin luminosity; Skin roughness; Skin smoothness; Skin texture; Anti-ageing; Healthy ageing

Outcome Measures

Primary Outcomes (1)

• Change in Facial Skin Glow

  Facial skin gloss will be measured at the right periocular area using the Skin-Glossymeter® GL 200 probe. Skin gloss values will be expressed in arbitrary units (AU), with a measurement range of 0 to 100 AU. Results will be reported as the mean change from baseline to Week 12. Higher values indicate greater skin gloss.

  Baseline (week 0) to week 12 (primary analysis at week 12; assessments at weeks 3, 6 and 12)

Secondary Outcomes (12)

• Change in Skin Glow at Additional Facial Areas

  Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)

• Change in Facial Skin Radiance

  Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)

• Change in Facial Stratum Corneum Hydration

  Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)

• Change in Facial Skin pH

  Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)

• Mean Change From Baseline in Facial Wrinkle (SEw)

  Baseline (week 0) to week 12 (assessments at weeks 3, 6 and 12)

Study Arms (2)

DERMIAL

EXPERIMENTAL

Hyaluronic acid matrix ingredien

Dietary Supplement: DERMIAL

PLACEBO

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

DERMIAL DIETARY_SUPPLEMENT

1 cap 60 mg/day

DERMIAL

Placebo OTHER

Placebo

PLACEBO

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: Female participants only.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to comply with all study requirements and restrictions, provide informed consent, understand and complete study questionnaires, and undergo all study-related procedures.
• Healthy women aged 35 to 65 years (inclusive) presenting signs of physiological facial skin ageing, defined as Grade II (Expression Wrinkles) or Grade III (Wrinkles at Rest) according to the Glogau Scale, as assessed by the investigator.
• Body mass index (BMI) between 18.0 and 34.9 kg/m² (inclusive). Willingness to maintain their usual cosmetic treatment routine throughout the study.
• Willingness to refrain from undergoing any facial rejuvenation treatments during the study.
• Willingness not to initiate nutritional supplements containing ingredients with potential skin-related effects during the study (e.g., hyaluronic acid, collagen, methylsulfonylmethane, vitamin C, soy, CoQ10, or antioxidants).
• Willingness not to initiate the use of new topical products other than those included in their usual skincare routine during the study.
• Willingness to maintain their normal lifestyle habits throughout the study (including sun exposure, diet, physical activity, and sleep habits).
• Women willing not to initiate or modify estrogen- or progesterone-based therapies during the study.
• Women willing to avoid pregnancy during the study by using appropriate contraceptive methods.
• Women willing not to use any skin-firming, skin-lightening, topical, or systemic medication known to affect skin ageing or dyschromia during the study period.

You may not qualify if:

• Regular use of hyaluronic acid-containing creams within the 3 months prior to enrolment.
• Regular use of oral supplements that may affect skin condition within the 3 months prior to enrolment.
• Changes in facial or body cosmetic routines within 1 month prior to enrolment.
• Use of medications affecting skin responses (e.g., glucocorticoids, antihistamines, immunomodulators).
• Presence of skin pigmentation disorders.
• Chronic sun exposure or planned use of tanning beds within 1 month prior to enrolment or during the study.
• Facial rejuvenation treatments (e.g., microneedling, needle mesotherapy, medium/deep chemical peels, ablative laser treatments, electrotherapy, intense pulsed light therapy) within the 4 months prior to enrolment.
• Self-reported allergy to cosmetic products and/or sunscreens.
• Use of hormonal contraceptives for less than 3 months before enrolment, or a change in contraceptive method within the 3 months prior to enrolment in women of childbearing potential.
• Employees of clinical laboratories, testing companies, cosmetic manufacturers, suppliers of topical product raw materials, or related industries.
• Pregnant, breastfeeding, or planning to become pregnant during the study.
• Known hypersensitivity, intolerance, or allergy to any study product, excipient, or rescue medication.
• Presence of inflammatory facial skin disorders at enrolment, including psoriasis, atopic dermatitis, rosacea, acne, or hidradenitis suppurativa.
• Type 1 diabetes, uncontrolled type 2 diabetes, uncontrolled hypertension (≥140 mmHg systolic or ≥90 mmHg diastolic), or uncontrolled thyroid disease.
• Known diseases interfering with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel syndrome, acute or chronic pancreatitis, pancreatic insufficiency).

Sponsors & Collaborators

• Bioiberica: lead
• IMDA - Instituto de Medicina y Dermatología Avanzada: collaborator

Study Sites (1)

Institute of Advanced Medicine and Dermatology (IMDA)

Madrid, Madrid, 28001, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 27, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

ES (1)