<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02204436</url>
  </required_header>
  <id_info>
    <org_study_id>E3013</org_study_id>
    <nct_id>NCT02204436</nct_id>
  </id_info>
  <brief_title>Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin</brief_title>
  <official_title>Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derming SRL</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Derming SRL</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study was to evaluate by instrumental measurements the depigmenting activity of a&#xD;
      cosmetic treatment for spotted hand skin; in particular it was investigated the synergic&#xD;
      activity of an emulsion, with clarifying-antioxidant activity combined with an activator gel,&#xD;
      with hydration and keratolytic activity.&#xD;
&#xD;
      Female healthy volunteers aged 45-65 years old, presenting senile lentigo on the hands, were&#xD;
      included in the study.&#xD;
&#xD;
      It was also aim of this study to evaluate treatment efficacy and cosmetic acceptability by&#xD;
      the volunteers and tolerance both by investigator and volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The following instrumental evaluations were performed in basal conditions (T0 - before&#xD;
      product use), after 4 (T4) and 8 week-treatment (T8):&#xD;
&#xD;
        -  Image analysis with UV flash (Wood's light)&#xD;
&#xD;
        -  Photographic recovery&#xD;
&#xD;
        -  Skin spots image analysis&#xD;
&#xD;
        -  Skin colour evaluation&#xD;
&#xD;
        -  Spectrophotometry (skin brightness)&#xD;
&#xD;
        -  Optical colorimetry (spots colour)&#xD;
&#xD;
      At the end of the study (T8), each volunteer filled a questionnaire regarding:&#xD;
&#xD;
        -  the efficacy of the study product (skin brightness and hydration, spots dimensions and&#xD;
           colour intensity - score: very marked; marked; medium; light; absent)&#xD;
&#xD;
        -  the cosmetic acceptability of the study product: colour and perfume before and after&#xD;
           application, consistency, spreadability, absorption, effect on the skin, greasiness and&#xD;
           presence of product residues (score: negative; medium; good; excellent) the product&#xD;
           tolerance (score: bad; poor; medium; good; excellent).&#xD;
&#xD;
      At the end of the study the investigator assessed the treatment tolerance considering the&#xD;
      possible appearance of related adverse events as bad, poor, medium, good, excellent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skin spots image analysis: change from baseline (T2, T4 and T8 vs. T0)</measure>
    <time_frame>after 2, 4 and 8-week-treatment</time_frame>
    <description>Skin spots area was measured on the pre-selected images performed with or without Wood's lamp. The measure of skin spots area was performed by means of an image analysis software, with a function called &quot;magic wand&quot;. Based on the colour similarities or on the difference of intensity ranges between the selected pixels (with a specified tolerance interval) the magic wand automatically traced the outline of the spot and measured the selected area (pixel2).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spectrophotometric evaluation: change from baseline (T2, T4 and T8 vs. T0)</measure>
    <time_frame>after 2, 4 and 8-week-treatment</time_frame>
    <description>Skin brightness was measured by a visible-UV-IR (λ from 300 to 900 nm) spectrophotometer which uses 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical colorimetry: change from baseline (T2, T4 and T8 vs. T0)</measure>
    <time_frame>after 2, 4 and 8 week-treatment</time_frame>
    <description>Measurement of spots colour were performed by a tri-stimulus colorimeter 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).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Emulsion and gel</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Emulsion and gel</intervention_name>
    <description>A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.</description>
    <arm_group_label>Emulsion and gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female healthy subjects&#xD;
&#xD;
          -  age 45-65 years&#xD;
&#xD;
          -  presence of moderate senile lentigo on the back of the hands&#xD;
&#xD;
          -  accepting to not receive any drugs/cosmetic/chemical or physical treatment (peeling,&#xD;
             intradermal implants etc.) able to change the skin characteristics during the entire&#xD;
             duration of the study&#xD;
&#xD;
          -  accepting to use the study product according to the instruction received by the&#xD;
             investigator&#xD;
&#xD;
          -  accepting not to expose to strong UV irradiation (UV session, or sun bathes) during&#xD;
             the entire duration of the study&#xD;
&#xD;
          -  subject agreeing not to use anti-spots products/treatments during the month preceding&#xD;
             the test&#xD;
&#xD;
          -  accepting to sign the Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  lactation&#xD;
&#xD;
          -  sensitivity to the test product or its ingredients&#xD;
&#xD;
          -  subjects whose insufficient adhesion to the study protocol is foreseeable&#xD;
&#xD;
          -  participation in a similar study actually or during the previous 3 months&#xD;
&#xD;
          -  dermatological disease (dermatitis; presence of cutaneous disease on the tested area,&#xD;
             as lesions, scars, malformations)&#xD;
&#xD;
          -  clinical and significant skin condition on the test area (e.g. active eczema,&#xD;
             dermatitis, psoriasis. etc.)&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  endocrine disease&#xD;
&#xD;
          -  hepatic disorder&#xD;
&#xD;
          -  renal disorder&#xD;
&#xD;
          -  cardiac disorder&#xD;
&#xD;
          -  pulmonary disease&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  neurological or psychological disease&#xD;
&#xD;
          -  inflammatory/immunosuppressive disease&#xD;
&#xD;
          -  drug allergy&#xD;
&#xD;
          -  systemic corticosteroids&#xD;
&#xD;
          -  aspirin or non-steroid anti-inflammatory drugs (FANS)&#xD;
&#xD;
          -  anti-histaminic, narcotic, antidepressant, immunosuppressive drugs (with except of&#xD;
             contraceptive or hormonal treatment starting from at least 1 year)&#xD;
&#xD;
          -  assumption of drugs able to influence the test results in the investigator opinion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adele Sparavigna, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Derming SRL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DermIng SRL</name>
      <address>
        <city>Monza</city>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.derming.com</url>
    <description>Investigator center</description>
  </link>
  <link>
    <url>http://www.giulianipharma.com/</url>
    <description>Sponsor</description>
  </link>
  <reference>
    <citation>Asawanonda P, Taylor CR. Wood's light in dermatology. Int J Dermatol. 1999 Nov;38(11):801-7. doi: 10.1046/j.1365-4362.1999.00794.x. No abstract available.</citation>
    <PMID>10583611</PMID>
  </reference>
  <reference>
    <citation>Asserin J., Heusèle C., André P. , Preece S., Schnebert S. , Taieb A. Comparison of two techniques used in the evaluation of the depigmentation effect of cosmetic products on brown spots, 2004</citation>
  </reference>
  <reference>
    <citation>Claridge E, Cotton S, Hall P, Moncrieff M. From colour to tissue histology: Physics-based interpretation of images of pigmented skin lesions. Med Image Anal. 2003 Dec;7(4):489-502. doi: 10.1016/s1361-8415(03)00033-1.</citation>
    <PMID>14561553</PMID>
  </reference>
  <reference>
    <citation>Claridge E, Preece SJ. An inverse method for the recovery of tissue parameters from colour images. Inf Process Med Imaging. 2003 Jul;18:306-17. doi: 10.1007/978-3-540-45087-0_26.</citation>
    <PMID>15344467</PMID>
  </reference>
  <reference>
    <citation>Curry AS, Gettings SD, McEwen GN CTFA safety testing guidelines. The Cosmetic, Toiletry and Fragrance Association, Washington, 1991</citation>
  </reference>
  <reference>
    <citation>Fernay, Voltaire The World Medical Association (1989) &quot;World Medical Association Declaration of Helsinki&quot;, Hong-Kong</citation>
  </reference>
  <reference>
    <citation>Fullerton A, Fischer T, Lahti A, Wilhelm KP, Takiwaki H, Serup J. Guidelines for measurement of skin colour and erythema. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1996 Jul;35(1):1-10. doi: 10.1111/j.1600-0536.1996.tb02258.x.</citation>
    <PMID>8896947</PMID>
  </reference>
  <reference>
    <citation>Gilchrest BA, Fitzpatrick TB, Anderson RR, Parrish JA. Localization of malanin pigmentation in the skin with Wood's lamp. Br J Dermatol. 1977 Mar;96(3):245-8. doi: 10.1111/j.1365-2133.1977.tb06132.x.</citation>
    <PMID>857837</PMID>
  </reference>
  <reference>
    <citation>Gupta LK, Singhi MK. Wood's lamp. Indian J Dermatol Venereol Leprol. 2004 Mar-Apr;70(2):131-5. No abstract available.</citation>
    <PMID>17642589</PMID>
  </reference>
  <reference>
    <citation>Matts Paul J., Carey Jeremy, Cotton Symon D. Chromophore Mapping: a New Technique to Characterize Aging Human Skin, In Vivo. American Academy of Dermatology 2005</citation>
  </reference>
  <reference>
    <citation>Matts PJ, Dykes PJ, Marks R. The distribution of melanin in skin determined in vivo. Br J Dermatol. 2007 Apr;156(4):620-8. doi: 10.1111/j.1365-2133.2006.07706.x.</citation>
    <PMID>17493065</PMID>
  </reference>
  <reference>
    <citation>Moncrieff M, Cotton S, Claridge E, Hall P. Spectrophotometric intracutaneous analysis: a new technique for imaging pigmented skin lesions. Br J Dermatol. 2002 Mar;146(3):448-57. doi: 10.1046/j.1365-2133.2002.04569.x.</citation>
    <PMID>11952545</PMID>
  </reference>
  <reference>
    <citation>Rieger M.M., Battista G.W. Some experiences in the safety testing of cosmetics J. Soc. Cosmet. Chem. 15:161 -172 , 1964</citation>
  </reference>
  <reference>
    <citation>Rigano L. &quot;Evaluation of the efficacy of a whitening product&quot; ISPE Institute of Skin and Product Evaluation - March 15th 2007</citation>
  </reference>
  <reference>
    <citation>Sachs L. Applied statistics: a handbook of techniques Heidelberg: Springer, 1981:536-539</citation>
  </reference>
  <reference>
    <citation>Taelman M-C, Dederen J. C. Relative performance testing of formulations: emulsifiers Cosmetics &amp;Toiletries magazine August 2000; 115: 37-42</citation>
  </reference>
  <reference>
    <citation>Takiwaki H. Measurement of skin color: practical application and theoretical considerations. J Med Invest. 1998 Feb;44(3-4):121-6.</citation>
    <PMID>9597799</PMID>
  </reference>
  <reference>
    <citation>Zonios G, Bykowski J, Kollias N. Skin melanin, hemoglobin, and light scattering properties can be quantitatively assessed in vivo using diffuse reflectance spectroscopy. J Invest Dermatol. 2001 Dec;117(6):1452-7. doi: 10.1046/j.0022-202x.2001.01577.x.</citation>
    <PMID>11886508</PMID>
  </reference>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hyperpigmentation</keyword>
  <keyword>depigmenting treatment</keyword>
  <keyword>hand</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02204436
org study id: E3013
nct id: NCT02204436
lead sponsor: 
has dmc: Yes
Aim of the study was to evaluate by instrumental measurements the depigmenting activity of a
      cosmetic treatment for spotted hand skin; in particular it was investigated the synergic
      activity of an emulsion, with clarifying-antioxidant activity combined with an activator gel,
      with hydration and keratolytic activity.

      Female healthy volunteers aged 45-65 years old, presenting senile lentigo on the hands, were
      included in the study.

      It was also aim of this study to evaluate treatment efficacy and cosmetic acceptability by
      the volunteers and tolerance both by investigator and volunteers.
The following instrumental evaluations were performed in basal conditions (T0 - before
      product use), after 4 (T4) and 8 week-treatment (T8):

        -  Image analysis with UV flash (Wood's light)

        -  Photographic recovery

        -  Skin spots image analysis

        -  Skin colour evaluation

        -  Spectrophotometry (skin brightness)

        -  Optical colorimetry (spots colour)

      At the end of the study (T8), each volunteer filled a questionnaire regarding:

        -  the efficacy of the study product (skin brightness and hydration, spots dimensions and
           colour intensity - score: very marked; marked; medium; light; absent)

        -  the cosmetic acceptability of the study product: colour and perfume before and after
           application, consistency, spreadability, absorption, effect on the skin, greasiness and
           presence of product residues (score: negative; medium; good; excellent) the product
           tolerance (score: bad; poor; medium; good; excellent).

      At the end of the study the investigator assessed the treatment tolerance considering the
      possible appearance of related adverse events as bad, poor, medium, good, excellent.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Skin spots image analysis: change from baseline (T2, T4 and T8 vs. T0)
time frame: after 2, 4 and 8-week-treatment
description: Skin spots area was measured on the pre-selected images performed with or without Wood's lamp. The measure of skin spots area was performed by means of an image analysis software, with a function called "magic wand". Based on the colour similarities or on the difference of intensity ranges between the selected pixels (with a specified tolerance interval) the magic wand automatically traced the outline of the spot and measured the selected area (pixel2).
measure: Spectrophotometric evaluation: change from baseline (T2, T4 and T8 vs. T0)
time frame: after 2, 4 and 8-week-treatment
description: Skin brightness was measured by a visible-UV-IR (λ from 300 to 900 nm) spectrophotometer which uses 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.
measure: Optical colorimetry: change from baseline (T2, T4 and T8 vs. T0)
time frame: after 2, 4 and 8 week-treatment
description: Measurement of spots colour were performed by a tri-stimulus colorimeter 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).
arm group label: Emulsion and gel
arm group type: Other
description: A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.
intervention type: Other
intervention name: Emulsion and gel
description: A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.
arm group label: Emulsion and gel
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adele Sparavigna, Doctor
role: Principal Investigator
affiliation: Derming SRL
facility: 
country: Italy
url: http://www.derming.com
description: Investigator center
url: http://www.giulianipharma.com/
description: Sponsor
citation: Asawanonda P, Taylor CR. Wood's light in dermatology. Int J Dermatol. 1999 Nov;38(11):801-7. doi: 10.1046/j.1365-4362.1999.00794.x. No abstract available.
PMID: 10583611
citation: Asserin J., Heusèle C., André P. , Preece S., Schnebert S. , Taieb A. Comparison of two techniques used in the evaluation of the depigmentation effect of cosmetic products on brown spots, 2004
citation: Claridge E, Cotton S, Hall P, Moncrieff M. From colour to tissue histology: Physics-based interpretation of images of pigmented skin lesions. Med Image Anal. 2003 Dec;7(4):489-502. doi: 10.1016/s1361-8415(03)00033-1.
PMID: 14561553
citation: Claridge E, Preece SJ. An inverse method for the recovery of tissue parameters from colour images. Inf Process Med Imaging. 2003 Jul;18:306-17. doi: 10.1007/978-3-540-45087-0_26.
PMID: 15344467
citation: Curry AS, Gettings SD, McEwen GN CTFA safety testing guidelines. The Cosmetic, Toiletry and Fragrance Association, Washington, 1991
citation: Fernay, Voltaire The World Medical Association (1989) "World Medical Association Declaration of Helsinki", Hong-Kong
citation: Fullerton A, Fischer T, Lahti A, Wilhelm KP, Takiwaki H, Serup J. Guidelines for measurement of skin colour and erythema. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1996 Jul;35(1):1-10. doi: 10.1111/j.1600-0536.1996.tb02258.x.
PMID: 8896947
citation: Gilchrest BA, Fitzpatrick TB, Anderson RR, Parrish JA. Localization of malanin pigmentation in the skin with Wood's lamp. Br J Dermatol. 1977 Mar;96(3):245-8. doi: 10.1111/j.1365-2133.1977.tb06132.x.
PMID: 857837
citation: Gupta LK, Singhi MK. Wood's lamp. Indian J Dermatol Venereol Leprol. 2004 Mar-Apr;70(2):131-5. No abstract available.
PMID: 17642589
citation: Matts Paul J., Carey Jeremy, Cotton Symon D. Chromophore Mapping: a New Technique to Characterize Aging Human Skin, In Vivo. American Academy of Dermatology 2005
citation: Matts PJ, Dykes PJ, Marks R. The distribution of melanin in skin determined in vivo. Br J Dermatol. 2007 Apr;156(4):620-8. doi: 10.1111/j.1365-2133.2006.07706.x.
PMID: 17493065
citation: Moncrieff M, Cotton S, Claridge E, Hall P. Spectrophotometric intracutaneous analysis: a new technique for imaging pigmented skin lesions. Br J Dermatol. 2002 Mar;146(3):448-57. doi: 10.1046/j.1365-2133.2002.04569.x.
PMID: 11952545
citation: Rieger M.M., Battista G.W. Some experiences in the safety testing of cosmetics J. Soc. Cosmet. Chem. 15:161 -172 , 1964
citation: Rigano L. "Evaluation of the efficacy of a whitening product" ISPE Institute of Skin and Product Evaluation - March 15th 2007
citation: Sachs L. Applied statistics: a handbook of techniques Heidelberg: Springer, 1981:536-539
citation: Taelman M-C, Dederen J. C. Relative performance testing of formulations: emulsifiers Cosmetics &Toiletries magazine August 2000; 115: 37-42
citation: Takiwaki H. Measurement of skin color: practical application and theoretical considerations. J Med Invest. 1998 Feb;44(3-4):121-6.
PMID: 9597799
citation: Zonios G, Bykowski J, Kollias N. Skin melanin, hemoglobin, and light scattering properties can be quantitatively assessed in vivo using diffuse reflectance spectroscopy. J Invest Dermatol. 2001 Dec;117(6):1452-7. doi: 10.1046/j.0022-202x.2001.01577.x.
PMID: 11886508
responsible party type: Sponsor