Efficacy and Tolerance Evaluation of a Topical "Revitalizing" Face Day Cream: Comparison Within Subjects Versus Placebo
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Derming SRL
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Profilometry: change from baseline (T4 and T8 vs. T0)
Study Overview
Brief Summary
Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the "revitalizing" activity of a face cream applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by healthy female volunteers aged 45-55 years with face ritidosis and women aged 55-65 years not habitual user of antiage-creams.
The study foresaw the comparison within subjects of the study product versus placebo (half face method).
It was also aim of this study to evaluate products efficacy and cosmetic acceptability by the volunteers and tolerance both by investigator and volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •female healthy subjects
- •age 45-55 years
- •women aged 55-65 years who are not habitual user of antiage-creams
- •presence of moderate face ritidosis
- •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
- •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
- •lactation
- •change in the normal habits regarding foods, physical activity, face cleansing and make-up use during the month preceding the test
- •sensitivity to the test products or theirs ingredients
- •subjects whose insufficient adhesion to the study protocol is foreseeable
- •participation in a similar study actually or during the previous 3 months
- •change in the normal life habits during the month preceding the inclusion
- •dermatological disease (dermatitis; 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
- •neurological or psychological disease
- •inflammatory/immunosuppressive disease
- •drug allergy
- •drugs/cutaneous medical or surgical procedures at level of the tested area during the previous 3 months
- •anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with except of contraceptive or hormonal treatment starting from at least 1 year);
- •assumption of drugs able to influence the test results in the investigator opinion
Arms & Interventions
plantaricin a (active product)
Volunteers applied the active product for an uninterrupted period of 8 weeks (on the right or on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage.
Intervention: plantaricin a (active product) (Other)
placebo product
Volunteers applied the placebo product for an uninterrupted period of 8 weeks (on the right or on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage
Intervention: placebo product (Other)
Outcomes
Primary Outcomes
Profilometry: change from baseline (T4 and T8 vs. T0)
Time Frame: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment)
A picture of crow's feet area was taken thanks to Primos compact portable device (GFMesstechnik); a software able to elaborate 3D representations of skin wrinkles as well as to measure skin principal profilometric parameters in vivo or on skin replicas, according to the law DIN EN ISO 4228; moreover the software compares directly the different images obtained at the times foresee by the protocol (T0, T4 and T8).The portable probe assures a constant distance from the skin as well as a fixed illumination angle of incidence; in this way is possible to acquire standardized and reproducible images.
Secondary Outcomes
- Optical colorimetry: change from baseline (T4 and T8 vs. T0)(T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment))
- Skin electrical capacitance: change from baseline (T4 and T8 vs. T0)(T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment))
- Photographic documentation:(T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment))
- Clinical evaluations: change from baseline (T4 and T8 vs. T0)(T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment))
- Skin plastoelasticity: change from baseline (T4 and T8 vs. T0)(T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment))
- Spectophotometry: change from baseline (T4 and T8 vs. T0)(T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment))
- Tape stripping:(T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment))