Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled Clinical Study Versus Untreated Group
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Moderate-severe Skin Aging/Photoaging
- Sponsor
- Derming SRL
- Enrollment
- 66
- Primary Endpoint
- Nasolabial folds visual score variation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Adele Sparavigna
Medical Doctor
Derming SRL
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
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.
- •Dependent on a clinical condition 4.4.2.
- •Dermatological disease,
- •Presence of cutaneous disease on the tested area as lesions, scars, malformations,
- •recurrent facial/labial herpes,
Outcomes
Primary Outcomes
Nasolabial folds visual score variation
Time Frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales
Skin plumpness clinical score variation
Time Frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Skin plumpness was evaluated using a 10 points scale from very poor to good
Skin resistance to pinching clinical score variation
Time Frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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
Skin radiance clinical score variation
Time Frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Skin radiance was evaluated using a 10 points scale from very poor to good
Surface microrelief regularity evaluation
Time Frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Regularity grade was evaluated according to this score: 1. = very regular 2. = regular 3. = irregular 4. = very irregular
Vascular homogeneity clinical score variation
Time Frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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
Crow's feet visual score variation
Time Frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales
Skin resistance to traction clinical score variation
Time Frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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
Skin recovery after pinching clinical score variation
Time Frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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
Pigmentary homogeneity clinical score variation
Time Frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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
Skin dryness clinical score variation
Time Frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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
Secondary Outcomes
- Superficial skin hydration(Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5))
- Deep skin hydration(Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5))
- Tolerance evaluation(Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5))
- Determination of roughness profilometric parameters(Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5))