<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/NCT03308370</url>
  </required_header>
  <id_info>
    <org_study_id>ETEPRPM</org_study_id>
    <nct_id>NCT03308370</nct_id>
  </id_info>
  <brief_title>Platelet Rich Plasma in Treatment of Melasma</brief_title>
  <official_title>Evaluation of the Therapeutic Effect of Platelet Rich Plasma in Melasma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Melasma is a common acquired disorder characterized by symmetric, hyperpigmented patches with&#xD;
      an irregular outline, occurring most commonly on the face. The therapy for melasma has always&#xD;
      been challenging and discouraging. Platelet rich plasma has been used over the last several&#xD;
      years as an effective treatment in various surgical and medical ﬁelds. In recent years,&#xD;
      Platelet rich plasma has also started to be used in the field of cosmetology. This study is&#xD;
      designed to evaluate the therapeutic effect of platelet rich plasma in melasma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Melasma is a pigmentary disorder that can be disfiguring and can cause to significant&#xD;
      emotional stresses for sufferers, for which a universally effective treatment is still&#xD;
      lacking. Platelet rich plasma is commonly used in dermatology and plastic surgery, especially&#xD;
      for treating chronic wounds, ulcers, and burns. The most important contents of platelets are&#xD;
      contained in the α-granules. Some of the bioactive substances present in the α-granules&#xD;
      include platelet-derived growth factor, transforming growth factor -β1 and -β2epidermal&#xD;
      growth factor, and mitogenic growth factors such as platelet-derived angiogenesis factor and&#xD;
      fibrinogen.&#xD;
&#xD;
      transforming growth factor -β1 decreases melanogenesis via delayed extracellular&#xD;
      signal-regulated kinase activation. The regression of melasma in a 27-years-old woman after&#xD;
      injecting platelet rich plasma for skin rejuvenation was observed, but controlled clinical&#xD;
      trials are still lacking to confirm this preliminary observation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">December 7, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</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>clinical improvement of melasma</measure>
    <time_frame>3 months</time_frame>
    <description>evaluation of the degree of clinical improvement of melasma by using platelet rich plasma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluation of transforming growth factor beta expression in the melasma skin</measure>
    <time_frame>3 months</time_frame>
    <description>compare the intensity of immunohistochemical expression of transforming growth factor beta in skin biopsies taken from the the lesional melasma skin ( of participants who accept only) before and after treatment with platelet rich plasma The results will be scored as follows: 0 for negative staining, 1+ for weak staining, 2+ for moderate staining intensity, and 3+ for strong positive staining.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Melasma</condition>
  <condition>Platelet Rich Plasma</condition>
  <arm_group>
    <arm_group_label>Platelet rich plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intradermal injection of 5 ml of autologous platelet rich plasma in the lesional skin of the face of 20 melasma patients every 4 weeks for 3 times</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet rich plasma</intervention_name>
    <description>10 ml of blood will be drawn from the patients on an anticoagulant then it will be centrifuged to get platelet rich plasma that will be injected in the melasma lesions of the patients after its activation with calcium chloride.</description>
    <arm_group_label>Platelet rich plasma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with melasma 18 years old or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years.&#xD;
&#xD;
          -  Pregnant females and females on oral contraceptive pills.&#xD;
&#xD;
          -  Patients with a history of hypertrophic scars or keloids.&#xD;
&#xD;
          -  Patients with recurrent herpes infection or with present cutaneous infection and those&#xD;
             with facial cancer.&#xD;
&#xD;
          -  Patients with blood disorders and platelet abnormalities and chronic liver disease.&#xD;
&#xD;
          -  Patients using systemic chemotherapy, anticoagulation therapy and antiplatelet agents.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alaa H Ghazally, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eman R Hofny, PHD</last_name>
    <phone>01005298992</phone>
    <email>e_riad@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amira A Abdel Motaleb, PHD</last_name>
    <phone>01005263721</phone>
    <email>amiraali21@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut university hospitals</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alaa H Ghazally, M.S.</last_name>
      <phone>01007224787</phone>
      <email>alaaghazally@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Grimes PE. Melasma. Etiologic and therapeutic considerations. Arch Dermatol. 1995 Dec;131(12):1453-7. doi: 10.1001/archderm.131.12.1453.</citation>
    <PMID>7492140</PMID>
  </reference>
  <reference>
    <citation>Cayirli M, Caliskan E, Acikgoz G, Erbil AH, Erturk G. Regression of melasma with platelet-rich plasma treatment. Ann Dermatol. 2014 Jun;26(3):401-2. doi: 10.5021/ad.2014.26.3.401. Epub 2014 Jun 12. No abstract available.</citation>
    <PMID>24966645</PMID>
  </reference>
  <reference>
    <citation>Kim DS, Park SH, Park KC. Transforming growth factor-beta1 decreases melanin synthesis via delayed extracellular signal-regulated kinase activation. Int J Biochem Cell Biol. 2004 Aug;36(8):1482-91. doi: 10.1016/j.biocel.2003.10.023.</citation>
    <PMID>15147727</PMID>
  </reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>October 7, 2017</study_first_submitted>
  <study_first_submitted_qc>October 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>June 25, 2018</last_update_submitted>
  <last_update_submitted_qc>June 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>A Ghazally</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03308370
org study id: ETEPRPM
nct id: NCT03308370
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Melasma is a common acquired disorder characterized by symmetric, hyperpigmented patches with
      an irregular outline, occurring most commonly on the face. The therapy for melasma has always
      been challenging and discouraging. Platelet rich plasma has been used over the last several
      years as an effective treatment in various surgical and medical ﬁelds. In recent years,
      Platelet rich plasma has also started to be used in the field of cosmetology. This study is
      designed to evaluate the therapeutic effect of platelet rich plasma in melasma.
Melasma is a pigmentary disorder that can be disfiguring and can cause to significant
      emotional stresses for sufferers, for which a universally effective treatment is still
      lacking. Platelet rich plasma is commonly used in dermatology and plastic surgery, especially
      for treating chronic wounds, ulcers, and burns. The most important contents of platelets are
      contained in the α-granules. Some of the bioactive substances present in the α-granules
      include platelet-derived growth factor, transforming growth factor -β1 and -β2epidermal
      growth factor, and mitogenic growth factors such as platelet-derived angiogenesis factor and
      fibrinogen.

      transforming growth factor -β1 decreases melanogenesis via delayed extracellular
      signal-regulated kinase activation. The regression of melasma in a 27-years-old woman after
      injecting platelet rich plasma for skin rejuvenation was observed, but controlled clinical
      trials are still lacking to confirm this preliminary observation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: clinical improvement of melasma
time frame: 3 months
description: evaluation of the degree of clinical improvement of melasma by using platelet rich plasma
measure: evaluation of transforming growth factor beta expression in the melasma skin
time frame: 3 months
description: compare the intensity of immunohistochemical expression of transforming growth factor beta in skin biopsies taken from the the lesional melasma skin ( of participants who accept only) before and after treatment with platelet rich plasma The results will be scored as follows: 0 for negative staining, 1+ for weak staining, 2+ for moderate staining intensity, and 3+ for strong positive staining.
arm group label: Platelet rich plasma
arm group type: Experimental
description: intradermal injection of 5 ml of autologous platelet rich plasma in the lesional skin of the face of 20 melasma patients every 4 weeks for 3 times
intervention type: Biological
intervention name: Platelet rich plasma
description: 10 ml of blood will be drawn from the patients on an anticoagulant then it will be centrifuged to get platelet rich plasma that will be injected in the melasma lesions of the patients after its activation with calcium chloride.
arm group label: Platelet rich plasma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alaa H Ghazally, MD
role: Principal Investigator
affiliation: Assiut University
last name: Eman R Hofny, PHD
phone: 01005298992
email: e_riad@yahoo.com
last name: Amira A Abdel Motaleb, PHD
phone: 01005263721
email: amiraali21@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Grimes PE. Melasma. Etiologic and therapeutic considerations. Arch Dermatol. 1995 Dec;131(12):1453-7. doi: 10.1001/archderm.131.12.1453.
PMID: 7492140
citation: Cayirli M, Caliskan E, Acikgoz G, Erbil AH, Erturk G. Regression of melasma with platelet-rich plasma treatment. Ann Dermatol. 2014 Jun;26(3):401-2. doi: 10.5021/ad.2014.26.3.401. Epub 2014 Jun 12. No abstract available.
PMID: 24966645
citation: Kim DS, Park SH, Park KC. Transforming growth factor-beta1 decreases melanin synthesis via delayed extracellular signal-regulated kinase activation. Int J Biochem Cell Biol. 2004 Aug;36(8):1482-91. doi: 10.1016/j.biocel.2003.10.023.
PMID: 15147727
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: A Ghazally
investigator title: principal investigator
mesh term: Melanosis
sharing ipd: Undecided