Moderate-severe Skin Aging/PhotoagingNCT03274154
Efficacy and Tolerance Evaluation of an Anti-age Food Supplement
A study testing Pre-Hyaluron 465 Innēov in people with Moderate-severe Skin Aging/Photoaging, run by Derming SRL.
Trial summary
Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled Clinical Study Versus Untreated Group Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Moderate-severe Skin Aging/Photoaging
- What is being tested?
- Pre-Hyaluron 465 Innēov
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 11 Oct 2016to 22 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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
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
- Moderate-severe Skin Aging/Photoaging
- Being tested
- Pre-Hyaluron 465 Innēov
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Hyaluron 465 InnēovDietary 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)
| Study group | Role | What they receive |
|---|---|---|
| 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) . Receives: Dietary Supplement: Pre-Hyaluron 465 Innēov |
| Untreated group | No intervention | 23 caucasian female subjects untreated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crow's feet visual score variation
Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start11 Oct 2016
- Primary completion22 Mar 2017
- Study completion22 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-severe Skin Aging/PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adele Sparavigna, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274154
- Sponsor's protocol ID
- DERMING E0116
- Status last verified
- Aug 2017
- First submitted
- 31 Aug 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled Clinical Study Versus Untreated Group
- ClinicalTrials.gov ID
- NCT03274154
- Acronym / sponsor ID
- DERMING E0116
- Conditions
- Moderate-severe Skin Aging/Photoaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 11 Oct 2016 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 22 Mar 2017 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Hyaluron 465 Innēov | Experimental | Dietary Supplement: Pre-Hyaluron 465 Innēov43 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) . |
| Untreated group | No intervention | –23 caucasian female subjects untreated |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (21 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Hyaluron 465 InnēovFood supplement consisting og a tablet and a capsule, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese) | Dietary supplement | Pre-Hyaluron 465 Innēov |
Primary outcome
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
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
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
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 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
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
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
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 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
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
4 secondary outcomes
Superficial skin hydration
Time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Deep skin hydration
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
Time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Tolerance evaluation
Time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Hyaluron 465 Innēov in people with Moderate-severe Skin Aging/Photoaging, run by Derming SRL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.