CompletedNCT03274154Updated Sep 6, 2017

Efficacy and Tolerance Evaluation of an Anti-age Food Supplement

An interventional study of Pre-Hyaluron 465 Innēov in Moderate-severe Skin Aging/Photoaging, sponsored by Derming SRL. Completed. Open to female participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-06.

Sponsored by Derming SRL · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 66
Allocation: Randomized
Ages: 35 Years to 60 Years
Sex: Female

Study summary

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

Read the 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 studied

Moderate-severe Skin Aging/Photoaging

Who can participate

Ages eligible: 35 Years to 60 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 66 participants (actual)

Study arms

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
No intervention
Untreated group
23 caucasian female subjects untreated

Interventions

Dietary supplementPre-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)

What researchers measure

Primary outcomes

Crow's feet visual score variation
Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales
Time frame: 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
Time frame: 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: 1. = very regular 2. = regular 3. = irregular 4. = very irregular
Time frame: 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 1. = important 2. = moderate 3. = weak 4. = very weak
Time frame: 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 1. = important 2. = moderate 3. = weak 4. = very weak
Time frame: 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 1. = important 2. = moderate 3. = weak 4. = very weak
Time frame: 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 1. = hydrated skin 2. = normal skin 3. = kindly dry skin 4. = dry skin 5. = very dry skin
Time frame: 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 1. = homogeneous 2. = quite not homogeneous 3. = not homogeneous 4. = very not homogeneous 5. = marked not homogeneous
Time frame: 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 1. = homogeneous 2. = quite not homogeneous 3. = not homogeneous 4. = very not homogeneous 5. = marked not homogeneous
Time frame: 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
Time frame: 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
Time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)

Secondary outcomes

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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)

Study locations

No study locations are listed for this record.

Registry details

Key details

Study ID: NCT03274154
Lead sponsor: Derming SRL
Responsible party: Adele Sparavigna (Medical Doctor, Derming SRL) — Principal investigator
First posted: Sep 6, 2017
Start date: Oct 11, 2016
Primary completion: Mar 22, 2017
Completion: Mar 22, 2017
Last update: Sep 6, 2017

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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