Efficacy and Tolerance Evaluation of an Anti-age Food Supplement

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

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

Study Overview

• Status: Completed
• Conditions: Moderate-severe Skin Aging/Photoaging
• Intervention / Treatment: Dietary supplement: Pre-Hyaluron 465 Innēov

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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) .	Dietary supplement: 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)
No Intervention: Untreated group; 23 caucasian female subjects untreated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crow's feet visual score variation	Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Nasolabial folds visual score variation	Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Surface microrelief regularity evaluation	Regularity grade was evaluated according to this score: = very regular; = regular; = irregular; = very irregular	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Skin resistance to pinching clinical score variation	The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important; = important; = moderate; = weak; = very weak	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Skin resistance to traction clinical score variation	The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important; = important; = moderate; = weak; = very weak	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Skin recovery after pinching clinical score variation	The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important; = important; = moderate; = weak; = very weak	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Skin dryness clinical score variation	Clinical evaluation of skin dryness was performed according to the following score: 0 = very hydrated skin; = hydrated skin; = normal skin; = kindly dry skin; = dry skin; = very dry skin	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Vascular homogeneity clinical score variation	Homogeneity grade was determined according to specific reference clinical and photographic scales and to the following clinical score: 0 = very homogeneous; = homogeneous; = quite not homogeneous; = not homogeneous; = very not homogeneous; = marked not homogeneous	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Pigmentary homogeneity clinical score variation	Homogeneity grade was determined according to specific reference clinical and photographic scales and to the following clinical score: 0 = very homogeneous; = homogeneous; = quite not homogeneous; = not homogeneous; = very not homogeneous; = marked not homogeneous	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Skin radiance clinical score variation	Skin radiance was evaluated using a 10 points scale from very poor to good	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Skin plumpness clinical score variation	Skin plumpness was evaluated using a 10 points scale from very poor to good	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superficial skin hydration	Skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Deep skin hydration	Tissue dielectric constant value of superficial and deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland)	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Determination of roughness profilometric parameters	Nasolabial folds profilometric parameters measured by Primos compact portable device (GFMesstechnik). Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth.	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Tolerance evaluation	The food supplement tolerance will be evaluated considering: any adverse event related to the study treatment, which occurred during the study; any judgement reported by the volunteers.	Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)

Collaborators and Investigators

• Sponsor: Derming SRL

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2016
• Primary Completion (Actual): March 22, 2017
• Study Completion (Actual): March 22, 2017

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: DERMING E0116

Drug and device information, study documents

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