Clinical Trial on a Topical "Antiage" Face Gel
Condition: Wrinkles
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the
      "antiage" activity of Gynomunal® gel after one single application on the face (short term
      evaluation) and 4 weeks of repeated use twice daily (long term evaluation) by healthy female
      volunteers.

      It is also aim of this study to evaluate cosmetic acceptability by the volunteers and
      efficacy and tolerance both by investigator and volunteers.
    

Detailed description: 
      Controlled clinical trial that foresees the application of the study product for an
      uninterrupted period of 4 weeks. 4 visits will be performed: a basal visit (T0), a short term
      evaluation 20 minutes after the 1st product application (T20min) and a long term evaluation
      after 2 (T2 - intermediate visit) and 4 (T4 - final visit) week-treatment.

      The study will be conducted on 33 healthy volunteers of female sex, 11 women for each of the
      following groups:

        -  35-44 years

        -  45-54 years

        -  55-65 years The volunteers accept to respect the rules fixed in the list of recruitment
           criteria and not to deviate from their normal life habits. Moreover, the month preceding
           the inclusion visit and during the entire period of treatment, normal cleansing habits
           must be maintained, sun and UV light exposure, avoided. In the case of UV exposure must
           be used a sun screen total block cream.

      Each volunteer is precisely informed about the study, a consent form being completed and
      signed. At the end of the study the investigator will declare to have informed all the
      volunteers participating it, signing and dating the relative form.

      The study will be started only after Independent Ethical Committee approval. It is understood
      that the treatment would be immediately interrupted as soon as the investigator judges it
      necessary.

      For each volunteer a Case Record Form is filled and to each one a progressive number is
      assigned. Personal data, subject's history, clinical and instrumental evaluations are
      registered in basal conditions and at all study visits.

      During 3 hours before the visit the volunteer must not smoke, drink coffee or alcohol. Any
      cosmetic product can be used on the skin test area during 2 hours before the visit. All
      measurements are performed under standard environmental conditions (Temperature=22+\-2°C;
      Relative Humidity<60%).

      Before each visit the volunteer will get acclimatized under relax conditions for at least
      10-15 min.

      Each volunteer will report on the personal diary card all information about the date, the
      time of study product application and a comment if necessary.

      At each visit, the volunteers must give back the diary card to the Investigator to verify
      their compliance.

      Samples are handled by DermIng in accordance with the methods described in the company
      operating procedures (SOP).

      This trial is carried out by DermIng in accordance with the methods described in its own
      company operating procedures (SOPs). The information and data on the trial are generated,
      recorded, documented and processed in accordance with the methods described in the following
      procedure, based on ICH GCP 1996. The trial is covered by an insurance policy provided by
      Polichem S.A. to cover any damages related to the study product.

      Statistical plan: the activity of the test product at T20min, T2 and T4 will be expressed in
      absolute values versus baseline (T0) for the entire population and for each evaluated group
      (35-44 yeas, 45-54 years, 55-65 years). Moreover a comparison between groups will be carried
      out at each considered time. Clinical data The statistical analysis of clinical data is
      carried out with not parametric test, while the analysis of all instrumental data are carried
      out with parametric test.
    

Intervention name(s): Gynomunal® gel
Intervention type(s): Drug
Intervention description(s): A fixed quantity of the cosmetic product will be applied on the face (including the submental area) twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage according to the instructions received by the investigator during the basal visit (T0).
Other intervention name(s): Ialuronic acid gel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiage