Efficacy and Tolerance Evaluation of an Anti-age Food Supplement

NCT ID: NCT03274154

Last Updated: 2017-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-11
• Study Completion Date: 2017-03-22

Brief Summary

Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled Clinical Study Versus Untreated Group

Detailed Description

Aim of the study was to evaluate the anti-age activity of "Pre-Hyaluron 465 Innēov" a food supplement, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese), taken for 4 consecutive months by female subjects aged 35-60 years (with preference for subjects over 45 years), with moderate-severe skin aging/photoaging according to a reference photographic scale.

The study foresaw the evaluation of the study product activity versus a control group, untreated.

Conditions

Moderate-severe Skin Aging/Photoaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-Hyaluron 465 Innēov

43 caucasian female subjects have taken during a meal, for the first 4 months of trial,1 capsule and 1 tablet/die of the food supplement composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese) .

Group Type: EXPERIMENTAL

Pre-Hyaluron 465 Innēov

Intervention Type: DIETARY_SUPPLEMENT

Food supplement consisting og a tablet and a capsule, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese)

Untreated group

23 caucasian female subjects untreated

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pre-Hyaluron 465 Innēov

Food supplement consisting og a tablet and a capsule, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• female sex,
• age 35-60 years (with preference for subjects over 45 years),
• body mass index (BMI) 18-27,
• caucasian healthy subjects with moderate-severe cutaneous aging/photoaging (score > 3 of the reference photographic scale in appendix 8),
• agreeing to present at each study visit without make-up,
• accepting to follow the instructions received by the investigator,
• accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products,
• agreeing not to apply any topical or take any oral product or nutritional supplementation (vitamins and minerals) other than the investigational products, or use face massages or other means known to improve skin wrinkles or skin qualities during the entire duration of the study,
• accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study,
• no participation in a similar study actually or during the previous 3 months
• accepting to sign the Informed consent form.

Exclusion Criteria

• Pregnancy,
• lactation,
• subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study,
• subjects not in menopause who do not accept to perform the pregnancy test at T0, T1, T2 and T3,
• sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
• subjects whose insufficient adhesion to the study protocol is foreseeable.

4.4.2. Dependent on a clinical condition 4.4.2.1. Dermatological disease,

• Presence of cutaneous disease on the tested area as lesions, scars, malformations,
• recurrent facial/labial herpes,
• clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
• Endocrine disease,
• hepatic disorder,
• renal disorder,
• cardiac disorder,
• pulmonary disease,
• cancer,
• neurological or psychological disease,
• inflammatory/immunosuppressive disease,
• drug allergy.
• Anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago),
• assumption of drugs or dietary supplements able to influence the test results in the investigator opinion.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Derming SRL

OTHER

Sponsor Role: lead

Responsible Party

Adele Sparavigna

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

DERMING E0116

Identifier Type: -

Identifier Source: org_study_id