Clinical trial NCT03274154: Efficacy and Tolerance Evaluation of an Anti-age Food Supplement
Official title: Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled Clinical Study Versus Untreated Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate-severe Skin Aging/Photoaging
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 66
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Crow's feet visual score variation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Nasolabial folds visual score variation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Surface microrelief regularity evaluation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Skin resistance to pinching clinical score variation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Skin resistance to traction clinical score variation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Skin recovery after pinching clinical score variation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Skin dryness clinical score variation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Vascular homogeneity clinical score variation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Pigmentary homogeneity clinical score variation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Skin radiance clinical score variation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Skin plumpness clinical score variation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Secondary outcomes:
measure: Superficial skin hydration
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Deep skin hydration
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Determination of roughness profilometric parameters
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
measure: Tolerance evaluation
timeFrame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Other outcomes:
Locations:
Study officials:
References: