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Skin AgingFILLERNCT02063971

Tolerance and Efficacy Evaluation of 3 Face Creams

A study testing Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002) in people with Skin Aging, run by Adele Sparavigna at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study will evaluate the tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure and also the tolerance and the efficacy of the F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002 placebo cream (comparison within subjects - half… Read more about this study

Who is it for?
Ages 35 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Skin Aging
What is being tested?
Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteItaly
Study dates
Dec 2013to Jun 2014
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 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • female gender
  • age > 35 years old
  • good general state of health
  • woman who had already undergone Hyaluronic acid injections
  • woman who have not applied any retinoid product in the last 3 months
  • woman who are not in a recovery period after laser/peeling/acne treatment
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  • accepting to return to the centre for the planned visits
  • accepting to follow the investigator's instructions during the entire study period
  • agreeing to present at each study visit without make-up
  • accepting to not change their habits regarding: food, physical activity, face cleansing and make-up use
  • agreeing to not receive any drug able to change the skin characteristics during the entire duration of the study
  • accepting to not receive any cutaneous anti-age treatment 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
  • accepting to sign the Informed consent form.

Who cannot join

  • Pregnancy (only for subjects not in menopause)
  • lactation (only for subjects not in menopause)
  • 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 during the basal visit (T0), 6 and 12 weeks after the intradermal implant execution;
  • subjects participating to a similar test less than 3 months ago
  • sensitivity to the test products or theirs ingredients
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  • subjects whose insufficient adhesion to the study protocol is foreseeable.
  • dermatitis
  • presence of cutaneous disease on the tested area as lesions, scars, malformations.
  • clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.)
  • recurrent facial/labial herpes.
  • diabetes
  • endocrine disease
  • hepatic disorder
  • renal disorder
  • cardiac disorder
  • pulmonary disease
  • digestive disease
  • haematological disease
  • chronic phlogosis or autoimmune disease
  • cancer
  • neurological or psychological disease
  • drug allergy.
  • systemic corticosteroids
  • retinoid products in the previous 3 months and during the entire study period
  • aspirin or non-steroid anti-inflammatory drugs (FANS)
  • anti-histaminic, narcotic, antidepressant, immunosuppressive drugs (with except, for female subjects, of contraceptive or hormonal treatment starting from at least one year)
  • assumption of drugs able to influence the test results in the investigator opinion.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • DERMING

    Monza, Monza-brianza, 20900

Other trials in Italy

About this study

Official title: Tolerance and Efficacy Evaluation of Three Face Creams in Subjects Undergoing to Injection Procedure With Hyaluronic Acid (Intradermal Implant)

The study will evaluate the tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure and also the tolerance and the efficacy of the F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002 placebo cream (comparison within subjects - half face method) to identify additional benefits delivered by the product compared to a cosmetic procedure.

Read the detailed description

First study phase (soothing activity)

  • Clinical grading (visual analogic scale):
  1. Erythema (0= no erythema to 10= strong erythema)
  2. Oedema (0= no oedema to 10= strong oedema)
  3. Bruise (0= no bruise to 10= strong bruise)
  4. Overall skin appearance (0= bad overall appearance to 10= good overall appearance).
  • Optical colorimetry: measurement of redness/bruise (L*a*b*) by Spectrophotometer CM-2600d.
  • Photographic documentation: Canfield imaging station equipped with visible, polarized, fluorescence and UV light and with specific lighting for shadows.

Second study phase (anti-age activity vs placebo):

  • Clinical and self grading (visual analogic scale) :
  1. Forehead wrinkles (0= no wrinkle to 10= severe wrinkles)
  2. Crow's feet wrinkles (0= no wrinkle to 10= severe wrinkles)
  3. Crow's feet fine lines (0= no fine line to 10= severe fine lines)
  4. Under the eye wrinkles (0= no wrinkle to 10= severe wrinkles)
  5. Under the eye fine lines (0= no fine line to 10= severe fine lines)
  6. Frown lines (0= no wrinkle to 10= severe wrinkles)
  7. Marionette lines (0= no wrinkle to 10= severe wrinkles)
  8. Upper lip wrinkles (0= no wrinkle to 10= severe wrinkles)
  9. Nasolabial folds (0= no wrinkle to 10= severe wrinkles)
  10. Cheek wrinkles (0= no wrinkle to 10= severe wrinkles)
  11. Neck wrinkles (0= no wrinkle to 10= severe wrinkles)
  12. Lines on the neck opening (0= no wrinkle to 10= severe wrinkles)
  13. Skin firmness (0= very firm skin to 10= no firm skin)
  14. Skin elasticity (0= very elastic skin to 10= no elastic skin)
  15. Sagging skin (0= no sagging skin to 10= severe sagging skin)
  16. Radiance (0= very radiant skin to 10= no radiant skin)
  17. Smoothness (0= very smooth skin to 10= no smooth skin)
  18. Skin softness (0= very soft skin to 10= no soft skin)
  19. Colour evenness (0= good evenness to 10= bad evenness)
  20. Skin tone (0= good complexion to 10= bad complexion)
  • Optical colorimetry: measurement of skin colour (L*a*b*) by Spectrophotometer CM-2600d.
  • Photographic documentation: Canfield imaging station equipped with visible, polarized, fluorescence and UV light and with specific lighting for shadows.
  • Skin replicas and profilometry at level of crow's feet (image analysis of: total surface of the wrinkles, mean length of the wrinkles, total length of the wrinkles, number of the wrinkles)
  • Skin elasticity measurement by suction (Cutometer®)

Tolerance evaluation (investigator's judgement):

At each evaluation time, the investigator considering the appearance of possible adverse effects related to the tested creams and all comments reported by the subjects on diary card will judge the tolerance of the products under study.

Conditions
Skin Aging
Being tested
Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002)
Keywords
Skin aging, Soothing activity, Hyaluronic acid injections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002)Other

Study groups in NCT02063971
Study groupRoleWhat they receive
Skin agingExperimentalAnti-age product will be applied once a day, in the evening, on half face and neck for an uninterrupted period of 12 weeks and the placebo cream in the morning with the same modalities. On the contralateral face side (right or left side according to a previous randomisation list), the volunteers will apply the placebo cream twice a day
Receives: Other: Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure on nasolabial folds

    For 7 days after injections (from T0 to T7d/T0'') the soothing cream will be applied twice a day on the full face and neck insisting on injection areas. 5 visits will be performed: a pre-test visit (T-30 subjects' screening), a baseline visit (T0 intradermal implant execution/ T0' evaluations just after the aesthetic procedure/ Timm evaluations immediately after the 1st soothing cream application), 2 intermediate visits (T1d, T3d - 1 and 3 days after injections) and a final visit (T7d - 7 days after the aesthetic procedure). Product tolerance (number of participants with adverse events) and efficacy:

    • clinical and self grading (performed on injection areas by VAS score)
    • optical colorimetry (on nasolabial folds - L*a*b*)
    • photographic documentation (of all the face) will be performed at each study time.

    Measured: 1 week

Secondary outcomes (1)

  1. Evaluation of the tolerance and the efficacy of the F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002 placebo cream to identify additional benefits delivered by the product compared to a cosmetic procedure

    The anti-age product will be applied once a day, in the evening, on half face and neck, for 12 weeks and the placebo cream in the morning with the same modalities. On the contralateral face side (according to a previous randomisation list), the volunteers will apply the placebo cream twice a day.

    5 visits will be performed: a baseline visit (T0 - before aesthetic procedure), a visit 7 days after injection (T0''/T7d), 2 intermediate visits (T4W and T8W - 4 and 8 weeks after the first study product application) and a final visit (T12W - 12 weeks after the first study product application).

    Tolerance (number of participants with adverse events) and efficacy:

    • clinical and self grading on face and neck (by VAS score)
    • optical colorimetry on both cheeks (L*a*b*)
    • photographic documentation of all the face
    • skin elasticity on both cheeks (deformation-mm)
    • wrinkles profilometry on the lateral corner of the eyes (micron) will be evaluated at each study time.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionApr 2014 (estimated)
  4. Study completionJun 2014 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02063971
Sponsor's protocol ID
E3513 / SC13-235
Acronym
FILLER
Status last verified
Feb 2014
First submitted
7 Feb 2014
Last updated
17 Feb 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002) in people with Skin Aging, run by Adele Sparavigna 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 14 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 17 Feb 2014. 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?

Results are not available in the source record.

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?

Tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure on nasolabial folds (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02063971.

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 17 Feb 2014.

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