Efficacy and Tolerance Evaluation of a Topical "Revitalizing" Face Day Cream

NCT02230397 | Completed Phase 3 DMC

• 1 other identifier: E2713
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

skin aging; anti-aging cream; wrinkles

Outcome Measures

Primary Outcomes (1)

• Profilometry: change from baseline (T4 and T8 vs. T0)

  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.

  T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment)

Secondary Outcomes (7)

• Skin electrical capacitance: change from baseline (T4 and T8 vs. T0)

  T0 (basal condition), 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)

• Optical colorimetry: 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)

Study Arms (2)

plantaricin a (active product)

OTHER

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.

Other: plantaricin a (active product)

placebo product

OTHER

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

Other: placebo product

Interventions

plantaricin a (active product) OTHER

Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage

plantaricin a (active product)

placebo product OTHER

Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage

placebo product

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.)
• diabetes
• endocrine disease
• hepatic disorder
• renal disorder
• cardiac disorder
• pulmonary disease
• cancer

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DermIng SRL

Monza, Monza, 20900, Italy

Location

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Related Links

• Investigation Center
• Sponsor

MeSH Terms

Interventions

plantaricin A

Study Officials

• Adele Sparavigna, Doctor

  Derming SRL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: September 3, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 3, 2014

Record last verified: 2014-07

Locations

IT (1)