Efficacy and Tolerance Evaluation of an Anti-age Food Supplement

NCT03274154 | Completed

• 1 other identifier: DERMING E0116
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Moderate-severe Skin Aging/Photoaging

Outcome Measures

Primary Outcomes (11)

• 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: 1. = very regular 2. = regular 3. = irregular 4. = 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 1. = important 2. = moderate 3. = weak 4. = 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 1. = important 2. = moderate 3. = weak 4. = 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 1. = important 2. = moderate 3. = weak 4. = 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 1. = hydrated skin 2. = normal skin 3. = kindly dry skin 4. = dry skin 5. = 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 1. = homogeneous 2. = quite not homogeneous 3. = not homogeneous 4. = very not homogeneous 5. = 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 1. = homogeneous 2. = quite not homogeneous 3. = not homogeneous 4. = very not homogeneous 5. = 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 Outcomes (4)

• 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)

• Determination of roughness profilometric parameters

  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)

Study Arms (2)

Pre-Hyaluron 465 Innēov

EXPERIMENTAL

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

Untreated group

NO INTERVENTION

23 caucasian female subjects untreated

Interventions

Pre-Hyaluron 465 Innēov 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)

Pre-Hyaluron 465 Innēov

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 4.4.2.1. 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,

Sponsors & Collaborators

• Derming SRL: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 6, 2017
• Study Start: October 11, 2016
• Primary Completion: March 22, 2017
• Study Completion: March 22, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-08