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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02230397
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Derming SRL

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.


Condition or disease Intervention/treatment Phase
Healthy Other: plantaricin a (active product) Other: placebo product Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerance Evaluation of a Topical "Revitalizing" Face Day Cream: Comparison Within Subjects Versus Placebo
Study Start Date : October 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
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.
Other: plantaricin a (active product)
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
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
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Skin electrical capacitance: change from baseline (T4 and T8 vs. T0) [ Time Frame: T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment) ]
    Hydration is measured by the instrument Corneometer CM825 (Courage - Khazaka, Köln, Germany): a square sensor (49mm2) frontally covered by a special glass, mounted on a spring cursor able to measure electrical capacity. Leaning the sensor on the skin surface, with a constant pressure thanks to the spring cursor it is possible to perform measures. The sensor acts as a capacitor. When a voltage is applied to this capacitor, the quantity of electric charge stored will be dependent on the dielectric properties of the material in contact with the probe. Water has an unusually high dielectric constant and so its presence in the skin is readily detectable by this method. So the measure of the skin capacitance properties is an indirect expression of its hydration level. To reduce the variability of measurement methods, for each evaluated side, three measures on the same skin area were executed: the adjusted mean will be considered as the real measure value.

  2. Skin plastoelasticity: change from baseline (T4 and T8 vs. T0) [ Time Frame: T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment) ]

    Skin plastoelasticity is measured with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK). This instrument is based on the principle of the torsion given to the skin surface by a probe made of two circles that adhere to the skin through shaped adhesive tapes. The internal circle rotation, while the external circle is still, exerts a constant torsion of the skin (torsion time = 1 second with a torque = 9mN*m). The instrument measures the torsion angle (θ) during the mechanical stimulus ("torque on") and after it has ceased ("torque off").For each of the considered curves the cutaneous rotational ratio relative to defined measured times can be measured, obtaining the parameters listed below:

    Ue: immediate extensibility ("torque on" at 0.02 sec.) Uf: maximum extensibility ("torque on" at 0.9 sec.) Uv: viscoelasticity Ur: immediate elastic recovery ("torque off" at 0.02 sec.).


  3. Spectophotometry: change from baseline (T4 and T8 vs. T0) [ Time Frame: T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment) ]
    Skin colour was measured by a visible-UV-IR (λ from 300 to 900 nm) spectrophotometer which use a tungsten halogen lamp and a deuterium lamp in accordance with CIE (Commission Internationale de l'Eclarage), the main international organisation concerned with colour and colour measurement. Lamps were switched on 30 minutes before instrument use in order to join a stable emission. Measurement angle was 90° (position of the probe on the skin) and measured area was 2 mm2; used wavelength range was 380-780 nm corresponds to the visible light spectrum.

  4. Optical colorimetry: change from baseline (T4 and T8 vs. T0) [ Time Frame: T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment) ]
    Measurement of skin brightness was performed by a tri-stimulus colorimeter (Chroma Meter CR-200®) equipped with three special filters to obtain R,G,B values in accordance with CIE (Commission Internationale de l'Eclarage), the main international organisation concerned with colour and colour measurement. CIE L*a*b* system (CIELAB) is the most complete colour-space specified by the CIE (1976). It describes all the colours visible to the human eye; the three coordinates of L*a*b* represent the lightness of the colour (L* = 0 yields black and L* = 100 indicates diffuse white; specular white may be higher), its position between red/magenta and green (a*, negative values indicate green while positive values indicate magenta) and its position between yellow and blue (b*, negative values indicate blue and positive values indicate yellow).

  5. Tape stripping: [ Time Frame: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment) ]

    Tape stripping was performed at each study time on the forehead on 10 selected subjects. The skin was not cleaned before tape stripping and tested area were marked with a black washable pencil. D-squame® discs (Monaderm, Monaco) with a diameter of 22mm were placed on the site of application (area without hair), applied with a constant pressure for 15 sec and then peeled off. The first two strips were discharged. Third and fourth strip were collected and stored at -20°C until following analysis listed below:

    • protein extraction and quantification
    • microscopic analysis
    • study of the expression of biological markers associated with skin ageing
    • study of ageing/oxidative stress

  6. Clinical evaluations: change from baseline (T4 and T8 vs. T0) [ Time Frame: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment) ]

    The following clinical evaluations were performed:

    wrinkles grade (nasolabial folds and "crow's feet"): 0 = no wrinkles; 1= very weak wrinkles; 2 = weak wrinkles; 3= quite evident wrinkles; 4 = evident wrinkles; 5 = very evident wrinkles; 6 = marked wrinkles; 7 = very marked wrinkles submental ptosis, scored from 0 (absence of ptosis - very regular oval face) to 5 (very marked ptosis - very irregular oval face) according to a clinical photographic scale.

    surface microrelief: 1 = very regular; 2 = regular; 3 = irregular; 4 = very irregular skin dullness (overall face): 1= luminous skin;2 = normal skin; 3= opaque skin; 4= very opaque skin skin resistance to pinching, to traction and recovery after pinching (malar region): 0 = very important;1 = important; 2 = moderate; 3 = weak; 4 = very weak skin dryness (malar region): 0 = very hydrated skin; 1= hydrated skin; 2 = normal skin; 3= kindly dry skin; 4= dry skin ; 5= very dry skin


  7. Photographic documentation: [ Time Frame: T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment) ]

    In basal condition (T0), at T4 and at T8 the investigator took lateral pictures of each volunteer. In order to assure comparable images, the pictures were taken with standardised methods, concerning especially:

    magnification factor intensity of illumination source (photographic lamps) angle of incidence and inclination of illumination Thanks to the application "remote trigger" (Canon EOS utility software) it was possible to overlay the first photographic image (T0) with the ones taken in the following times (T4 and T8); so it was possible to have totally comparable images.




Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02230397


Locations
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Italy
DermIng SRL
Monza, Italy, 20900
Sponsors and Collaborators
Derming SRL
Investigators
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Principal Investigator: Adele Sparavigna, Doctor Derming SRL
Additional Information:
Publications:
De Rigal J, Leveque JL In vivo measurement of the stratum corneum elasticity Bioengineering and the skin 1: 13-23, 1985
Elsner P, Berardesca E, Maibach H Bioengineering of the skin: Water and the stratum corneum CRC Press, Boca Raton, 1994
Elsner P, Barel AO, Berardesca E, Gapard B, Serup J Skin Bioengineering Techniques and Applications in Dermatology and Cosmetology Karger, 1998
Fernay, Voltaire The World Medical Association (1989) "World Medical Association Declaration of Helsinki", Hong-Kong.
Frankowsky G., Hainich R., GFMesstechnik GmbH Germany DLP-Based 3D metrology by structured light or projected fringe technology for life sciences and industrial metrology Proc. SPIE Photonics West: 1-12, 2009
Hoppe U, Sauermann G, Lunderstadt R Quantitative analysis of the skin surface by means of digital signal processing J Soc Cosmet Chem 36: 105-123, 1985
Hof, C., Hopermann, H.: University of the Federal Armed Forces, Hamburg Comparison of Replica - and In Vivo - Measurement of the Microtopography of Human Skin
Jaspers S., Bretschneider T., Maerkeer U., Ennen J. Optical topometry with Primos: a powerful tool to prove the efficacy on skin care products in in-vivo studies XXI IFSCC International Congress Proceeding, 430-434
Jaspers S., Hopermann H. et all Rapid in vivo measurement of the topography of human skin by active image triangulation using a digital micromirror device Skin Research and Technology 5: 195-207, 2006
Rieger M.M., Battista G.W. Some experiences in the safety testing of cosmetics J. Soc. Cosmet. Chem. 15:161 -172 (1964)
Sachs L Applied statistics: a handbook of techniques Heidelberg: Springer, 536-539, 1981
Sparavigna A., Setaro M., Galbiati G. Osservazioni sull'elasticità della pelle Cosmesi Dermatologica 22:68-78, 1988
Sparavigna A., Setaro M., A new evaluation method of skin plastoelasticity in skin Pharmacology and toxicology. Recent advances Plenum Publishing Corporation, New York, London: 295-298, 1990
Sparavigna A., Galbiati G. La plastoelasticità cutanea: Metodi di indagine e significato clinico Cronica Dermatologica 4: 509-517, 1992
Sparavigna A., Setaro M. Misurazione delle proprietà meccaniche della cute mediante metodi di torsione In:"Diagnostica non invasiva in dermatologia" A cura di Stefania Seidenari, EDRA Medical Publishing & New Media, Milano, 1998, 323-328
Sparavigna A., Setaro M. Elasticità della pelle La Pelle: Dermatologia, anno 14, mag-giu (5) 2009
Sparavigna A., Setaro M., Di Pietro A. Healthy skin 2005: results of Italian study on healthy population with particular regard to the ageing phenomenon J. Plastic Dermatol 2006; 2:23-9
Setaro M., Sparavigna A. Is it possible to define a biological age of the skin? Preprints of 1st Joint Meeting: 14th International Congress for Bioengineering and the Skin and 8th Congress of the International Society for Skin Imaging. May 21-24, 2003, Hamburg, Germany
Taelman M-C, Dederen J. C. Relative performance testing of formulations: emulsifiers Cosmetics &Toiletries magazine August 2000; 115: 37-42
Wilhelm KP, Elsner P, Berardesca E, Maibach HI Bioengineering of the skin: Skin surface imaging and analysis CRC Press, Boca Raton, 1997

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Responsible Party: Derming SRL
ClinicalTrials.gov Identifier: NCT02230397    
Other Study ID Numbers: E2713
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: July 2014
Keywords provided by Derming SRL:
skin aging
anti-aging cream
wrinkles