Face Aging/Photo Aging of Moderate GradeNCT03276897
Efficacy and Tolerance Evaluation of a "Revitalizing" Face Treatment
A study testing Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy) in people with Face Aging/Photo Aging of Moderate Grade, run by Derming SRL at 1 site in Italy.
Trial summary
Efficacy and Tolerance Evaluation of a"revitalizing" face treatment consisting of a day and a night cream 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
- Face Aging/Photo Aging of Moderate Grade
- What is being tested?
- Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2017to 30 Jun 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,
- Caucasian subjects,
- presence of moderate face ritidosis,
- 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, face cleansing and make- up use,
- agreeing not to apply or take any product or use face massages or other means known to improve skin wrinkle and 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 currently or during the previous 3 months
- accepting to sign the Informed consent form.
Who cannot join
- Pregnancy,
- lactation,
- sensitivity to the test products or their ingredients (to be assessed by the investigator during the baseline visit),
- subjects whose insufficient adhesion to the study protocol is foreseeable.
- presence of cutaneous disease on the tested area as lesions, scars, malformations,
- recurrent facial/labial herpes,
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- 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),
- using of drugs or dietary supplements able to influence the test results in the investigator opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Efficacy and Tolerance Evaluation of a"revitalizing" face treatment consisting of a day and a night cream
Read the detailed description
Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the activity of a "revitalizing" face treatment consisting of a day and a night cream, applied for an uninterrupted period of 3 months, by female volunteers, aged 35-60 years, with aging/photo aging of moderate grade.
- Conditions
- Face Aging/Photo Aging of Moderate Grade
- Being tested
- Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)Other
A fixed quantity of both cosmetic products was applied for an uninterrupted period of 3 months, on the face included the submental area (day cream at the morning and the night cream at the evening), preferentially always at the same hour, with a mild massage
| Study group | Role | What they receive |
|---|---|---|
| Nutriage SPF 30 day cream and Nutriage night cream | Experimental | Application of the study products (day cream at the morning and night cream at the evening), for an uninterrupted period of 3 months. Receives: Other: Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of wrinkles grade, around the eyes (Crow's feet)
Variation of wrinkles grade from baseline of the Glogau's reference photographic scale (visual score from 1-4) where:
- Type 1: early wrinkles
- Type 2: wrinkle in motion
- Type 3: wrinkles at rest
- Type 4: Only wrinkles
Measured: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Change of wrinkles grade of nasolabial folds
Variation of wrinkles grade from baseline of the Lemperle's reference photographic scale (visual score from 1-6) where:
- Grade 1: no wrinkles
- Grade 2: just perceptible wrinkles
- Grade 3: shallow wrinkles
- Grade 4: moderately deep wrinkles
- Grade 5: deep wrinkles, well-defined folds
- Grade 6: very deep wrinkles, redundant fold
Measured: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Change of skin surface microrelief's regularity
Variation of skin surface microrelief's regularity grade from baseline of cheek surface microrelief photographic scale where:
- Grade 1:very regular
- Grade 2: regular
- Grade 3: irregular
- Grade 4: very irregular.
Measured: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Change of skin resistance to pinching clinical score
The evaluation was performed at level of cheek (malar region) according to the following score:
0 = very important
- = important
- = moderate
- = weak
- = very weak
Measured: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Change of skin resistance to traction clinical score
The evaluation was performed at level of cheek (malar region) according to the following score:
0 = very important
- = important
- = moderate
- = weak
- = very weak
Measured: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Change of skin recovery after pinching clinical score
The evaluation was performed at level of cheek (malar region) according to the following score:
0 = very important
- = important
- = moderate
- = weak
- = very weak
Measured: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Change of skin dryness clinical score
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: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Change of vascular and pigmentary homogeneity clinical score
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: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Secondary outcomes (2)
Change of roughness profilometric parameters
Crow's feet 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: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Photographic documentation (3D pictures)
Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.
Measured: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start21 Mar 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Face Aging/Photo Aging of Moderate GradeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT03276897
- Sponsor's protocol ID
- E0517
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance Evaluation of a "Revitalizing" Face Treatment
- ClinicalTrials.gov ID
- NCT03276897
- Acronym / sponsor ID
- E0517
- Conditions
- Face Aging/Photo Aging of Moderate Grade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 8 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 a"revitalizing" face treatment consisting of a day and a night cream
Detailed description
Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the activity of a "revitalizing" face treatment consisting of a day and a night cream, applied for an uninterrupted period of 3 months, by female volunteers, aged 35-60 years, with aging/photo aging of moderate grade.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutriage SPF 30 day cream and Nutriage night cream | Experimental | Other: Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)Application of the study products (day cream at the morning and night cream at the evening), for an uninterrupted period of 3 months. |
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,
- Caucasian subjects,
- presence of moderate face ritidosis,
- agreeing to present at each study visit without make-up,
Key exclusion criteria (18 listed)
- Pregnancy,
- lactation,
- sensitivity to the test products or their ingredients (to be assessed by the investigator during the baseline visit),
- subjects whose insufficient adhesion to the study protocol is foreseeable.
- presence of cutaneous disease on the tested area as lesions, scars, malformations,
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 |
|---|---|---|
| Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)A fixed quantity of both cosmetic products was applied for an uninterrupted period of 3 months, on the face included the submental area (day cream at the morning and the night cream at the evening), preferentially always at the same hour, with a mild massage | Other | Nutriage SPF 30 day cream and Nutriage night cream |
Primary outcome
Change of wrinkles grade, around the eyes (Crow's feet)
Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Variation of wrinkles grade from baseline of the Glogau's reference photographic scale (visual score from 1-4) where: * Type 1: early wrinkles * Type 2: wrinkle in motion * Type 3: wrinkles at rest * Type 4: Only wrinkles
Change of wrinkles grade of nasolabial folds
Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Variation of wrinkles grade from baseline of the Lemperle's reference photographic scale (visual score from 1-6) where: * Grade 1: no wrinkles * Grade 2: just perceptible wrinkles * Grade 3: shallow wrinkles * Grade 4: moderately deep wrinkles * Grade 5: deep wrinkles, well-defined folds * Grade 6: very deep wrinkles, redundant fold
Change of skin surface microrelief's regularity
Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Variation of skin surface microrelief's regularity grade from baseline of cheek surface microrelief photographic scale where: * Grade 1:very regular * Grade 2: regular * Grade 3: irregular * Grade 4: very irregular.
Change of skin resistance to pinching clinical score
Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
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
Change of skin resistance to traction clinical score
Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
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
Change of skin recovery after pinching clinical score
Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
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
Change of skin dryness clinical score
Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
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
Change of vascular and pigmentary homogeneity clinical score
Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
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
2 secondary outcomes
Change of roughness profilometric parameters
Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Photographic documentation (3D pictures)
Time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
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 8 Sep 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy) in people with Face Aging/Photo Aging of Moderate Grade, run by Derming SRL at 1 site in Italy.
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 18 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 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change of wrinkles grade, around the eyes (Crow's feet) (time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)). The study lists 8 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 8 Sep 2017.