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Tolerance and Efficacy Evaluation of 3 Face Creams (FILLER)

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ClinicalTrials.gov Identifier: NCT02063971
Recruitment Status : Unknown
Verified February 2014 by Adele Sparavigna, Derming SRL.
Recruitment status was:  Active, not recruiting
First Posted : February 17, 2014
Last Update Posted : February 17, 2014
Sponsor:
Information provided by (Responsible Party):
Adele Sparavigna, Derming SRL

Brief 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 face method) to identify additional benefits delivered by the product compared to a cosmetic procedure.

Condition or disease Intervention/treatment Phase
Skin Aging Other: Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Tolerance and Efficacy Evaluation of Three Face Creams in Subjects Undergoing to Injection Procedure With Hyaluronic Acid (Intradermal Implant)
Study Start Date : December 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Aging

Arm Intervention/treatment
Experimental: Skin aging
Anti-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
Other: Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002)



Primary Outcome Measures :
  1. 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 ]

    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.


Secondary Outcome Measures :
  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 [ Time Frame: 3 months ]

    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.



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063971


Locations
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Italy
DERMING
Monza, Monza-brianza, Italy, 20900
Sponsors and Collaborators
Adele Sparavigna
Investigators
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Principal Investigator: ADELE SPARAVIGNA, PHYSICIAN Derming SRL

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Responsible Party: Adele Sparavigna, Physician, Derming SRL
ClinicalTrials.gov Identifier: NCT02063971     History of Changes
Other Study ID Numbers: E3513 / SC13-235
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: February 17, 2014
Last Verified: February 2014

Keywords provided by Adele Sparavigna, Derming SRL:
Skin aging
Soothing activity
Hyaluronic acid injections

Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents