<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/NCT03811145</url>
  </required_header>
  <id_info>
    <org_study_id>CTL/LE/01/0514</org_study_id>
    <nct_id>NCT03811145</nct_id>
  </id_info>
  <brief_title>An Investigation of Tendoncel, a Novel Topical Platelet Lysate Gel, in the Treatment of Lateral Epicondylitis</brief_title>
  <official_title>A Double-Blind Randomised Placebo-controlled Phase IIb Clinical Trial to Study the Efficacy &amp; Safety of a Novel Platelet Lysate Gel in the Treatment of Lateral Epicondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cell Therapy Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>George Papanicolaou Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cell Therapy Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current treatments for lateral epicondylitis include: rest, behaviour modification and&#xD;
      physiotherapy, anti-inflammatory medication - both steroidal and non-steroidal, and surgery.&#xD;
      Current experimental therapies include muscle relaxants to reduce muscle tone and force on&#xD;
      the epicondyle, laser therapy to stimulate collagen production, and blood based therapies&#xD;
      including the injection of autologous blood and protein rich plasma.&#xD;
&#xD;
      Cell Therapy Ltd (trading as Celixir) has developed a regenerative gel that combines isolated&#xD;
      allogeneic platelet growth factors and a cellulose-derivative gel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lateral epicondylitis, also called &quot;tennis elbow&quot; is a common condition affecting 1 to 3% of&#xD;
      the population; most commonly individuals aged 35 to 55 years. It is frequently self limiting&#xD;
      but can lead to refractory symptoms in a minority of cases. Pain is localised to the lateral&#xD;
      epicondyle of the elbow at the point of insertion of the common extensor tendon. Although&#xD;
      associated with repetitive movement of the extensor muscles of the forearm, frequently no&#xD;
      precipitating cause can be discerned.&#xD;
&#xD;
      The term &quot;epicondylitis&quot; is a misnomer as histological investigations have revealed that&#xD;
      there is only limited inflammation, and the term &quot;epicondylosis&quot; should be employed, due to&#xD;
      the degenerative nature of the condition.&#xD;
&#xD;
      The condition is divided in to 4 stages, though progression may not occur through all four.&#xD;
      Firstly, there is acute inflammation that is quick to resolve. Secondly, prolonged injury&#xD;
      results in an increase in fibroblasts, vascular hyperplasia, disorganised collagen&#xD;
      disposition and degeneration of the tendon. Thirdly, further accumulation of structural&#xD;
      alterations leads to partial or complete tendon rupture. Stage 4 exhibits the same features&#xD;
      as 2 and 3 but with the addition of calcification.&#xD;
&#xD;
      Current treatments for lateral epicondylitis include: rest, behaviour modification and&#xD;
      physiotherapy, anti-inflammatory medication both steroidal and non-steroidal, and surgery.&#xD;
      Current experimental therapies include muscle relaxants to reduce muscle tone and force on&#xD;
      the epicondyle, laser therapy to stimulate collagen production, and blood based therapies&#xD;
      including the injection of autologous blood and protein rich plasma. Trials of the latter two&#xD;
      treatments give conflicting results due to variations in protocol and trial design.&#xD;
&#xD;
      Cell Therapy Ltd has developed a regenerative gel, Tendoncel, that combines isolated platelet&#xD;
      growth factors and cellulose-derivative gel. Tendoncel consists of a proprietary platelet&#xD;
      lysate formulation that is easy to apply to the skin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire</measure>
    <time_frame>Day 23 (end of treatment).</time_frame>
    <description>15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire</measure>
    <time_frame>4 weeks follow up</time_frame>
    <description>15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire</measure>
    <time_frame>6 weeks follow up.</time_frame>
    <description>15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire</measure>
    <time_frame>3 months follow up.</time_frame>
    <description>15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire</measure>
    <time_frame>Mean of 47 weeks follow up.</time_frame>
    <description>15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire</measure>
    <time_frame>Day 23.</time_frame>
    <description>30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire</measure>
    <time_frame>4 week follow up.</time_frame>
    <description>30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire</measure>
    <time_frame>6 week follow up.</time_frame>
    <description>30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire</measure>
    <time_frame>3 months follow up</time_frame>
    <description>30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire</measure>
    <time_frame>Mean of 47 weeks follow up.</time_frame>
    <description>30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain free grip strength</measure>
    <time_frame>Baseline</time_frame>
    <description>Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain free grip strength</measure>
    <time_frame>Day 23</time_frame>
    <description>Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain free grip strength</measure>
    <time_frame>Mean of 47 weeks follow up (final follow up).</time_frame>
    <description>Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety - Number of participants in each group with adverse events.</measure>
    <time_frame>Day 3 (1st treatment visit), day 7, day 14, day 21, day 23 (end of treatment). Follow ups: 4 weeks, 6 weeks, 3 months and mean of 47 weeks.</time_frame>
    <description>Measured by participant questionnaire. Comparison of the number of participants in each group with cutaneous events - &quot;redness&quot;, &quot;rash&quot;, &quot;swelling&quot; or changes at gel site. Classed as none, mild, moderate or severe. Plus any other event mentioned by the participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Immune response - blood IgE levels. Difference between test and control groups.</measure>
    <time_frame>Baseline</time_frame>
    <description>Measurement of blood IgE levels. Test and control averages compared. Normal is &lt;100IU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Immune response - blood IgE levels. Difference between test and control groups.</measure>
    <time_frame>Day 7</time_frame>
    <description>Measurement of blood IgE levels. Test and control averages compared. Normal is &lt;100IU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Immune response - blood IgE levels. Difference between test and control groups.</measure>
    <time_frame>Day 23</time_frame>
    <description>Measurement of blood IgE levels. Test and control averages compared. Normal is &lt;100IU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Immune response - blood IgE levels. Number of participants in each group with a normal baseline reading and a subsequently elevated reading.</measure>
    <time_frame>Baseline, day 7 and day 23.</time_frame>
    <description>Measurement of blood IgE levels. Comparison of the number of participants in each group, test and control, with a normal baseline reading of blood IgE and a subsequently elevated IgE reading. Normal is &lt;100IU/mL.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Lateral Epicondylitis</condition>
  <arm_group>
    <arm_group_label>Tendoncel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topically applied experimental gel - Tendoncel. 80ul applied once a day for 21 consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo control gel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo control gel. Similar to Tendoncel but without platelet derived small molecules and growth factors. 80ul applied once a day for 21 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Tendoncel</intervention_name>
    <description>Platelet lysate gel</description>
    <arm_group_label>Tendoncel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo control gel</intervention_name>
    <description>Placebo control gel</description>
    <arm_group_label>Placebo control gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 18 years and over and in good general health&#xD;
&#xD;
          -  Subjects who have a diagnosis of lateral epicondylitis, Cozen's test&#xD;
&#xD;
          -  Subjects who are willing to attend all study assessments and follow-up appointments&#xD;
&#xD;
          -  Subjects who are able to understand the study, and are willing to co-operate with the&#xD;
             study procedures and restrictions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects have been receiving additional concurrent treatment (e.g. surgical or steroid&#xD;
             injection) for lateral epicondylitis.&#xD;
&#xD;
          -  Subjects who have medial epicondylitis or another condition of the elbow (test side&#xD;
             only)&#xD;
&#xD;
          -  Subjects who have participated in any clinical study during the previous 30 days of&#xD;
             initiation of this study&#xD;
&#xD;
          -  Subjects with a history of alcohol, substance or drug abuse in the previous 12 months&#xD;
&#xD;
          -  Subjects with any significant concurrent illness&#xD;
&#xD;
          -  Subjects with a heart pacemaker&#xD;
&#xD;
          -  Subjects with diabetes either type I or type II (owing to possible poor wound healing)&#xD;
&#xD;
          -  Subjects that have undergone surgery in the past 3 months&#xD;
&#xD;
          -  Subjects with any active or significant history of skin disorders at the treatment&#xD;
             area(s) e.g. hypo pigmentation (vitiligo)&#xD;
&#xD;
          -  Subjects with any inflammatory skin condition (eczema, psoriasis, herpes&#xD;
             simplex/complex)&#xD;
&#xD;
          -  Subjects with a history (or family history) of skin cancer, skin tumours or any other&#xD;
             malignant disease&#xD;
&#xD;
          -  Subjects with any irritation, tattoo's, piercings, scars, birthmarks, or heavy&#xD;
             presence of freckles at the treatment site(s)&#xD;
&#xD;
          -  Subjects currently taking anti-histamine or steroid medication&#xD;
&#xD;
          -  Subject who due to impaired mobility would not be able to undertake independent care&#xD;
&#xD;
          -  Subjects who are pregnant or who are breast feeding.&#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>Givissis Panagiotis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aristotle University of Thessaloniki, General Hospital of Papanikolaou</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopaedic Clinic of Aristotle University of Thessaloniki, General Hospital of Papanikolaou</name>
      <address>
        <city>Thessaloniki</city>
        <zip>57010</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <link>
    <url>https://online.boneandjoint.org.uk/doi/pdf/10.1302/0301-620X.95B9.29285</url>
    <description>Ahmad et al., (2013)</description>
  </link>
  <reference>
    <citation>Ahmad Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Rushton N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013 Sep;95-B(9):1158-64. doi: 10.1302/0301-620X.95B9.29285.</citation>
    <PMID>23997125</PMID>
  </reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>December 11, 2019</last_update_submitted>
  <last_update_submitted_qc>December 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Topical</keyword>
  <keyword>Gel</keyword>
  <keyword>Platelet</keyword>
  <keyword>Growth factor</keyword>
  <keyword>Regenerative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03811145
org study id: CTL/LE/01/0514
nct id: NCT03811145
lead sponsor: 
collaborator: 
has dmc: No
Current treatments for lateral epicondylitis include: rest, behaviour modification and
      physiotherapy, anti-inflammatory medication - both steroidal and non-steroidal, and surgery.
      Current experimental therapies include muscle relaxants to reduce muscle tone and force on
      the epicondyle, laser therapy to stimulate collagen production, and blood based therapies
      including the injection of autologous blood and protein rich plasma.

      Cell Therapy Ltd (trading as Celixir) has developed a regenerative gel that combines isolated
      allogeneic platelet growth factors and a cellulose-derivative gel.
Lateral epicondylitis, also called "tennis elbow" is a common condition affecting 1 to 3% of
      the population; most commonly individuals aged 35 to 55 years. It is frequently self limiting
      but can lead to refractory symptoms in a minority of cases. Pain is localised to the lateral
      epicondyle of the elbow at the point of insertion of the common extensor tendon. Although
      associated with repetitive movement of the extensor muscles of the forearm, frequently no
      precipitating cause can be discerned.

      The term "epicondylitis" is a misnomer as histological investigations have revealed that
      there is only limited inflammation, and the term "epicondylosis" should be employed, due to
      the degenerative nature of the condition.

      The condition is divided in to 4 stages, though progression may not occur through all four.
      Firstly, there is acute inflammation that is quick to resolve. Secondly, prolonged injury
      results in an increase in fibroblasts, vascular hyperplasia, disorganised collagen
      disposition and degeneration of the tendon. Thirdly, further accumulation of structural
      alterations leads to partial or complete tendon rupture. Stage 4 exhibits the same features
      as 2 and 3 but with the addition of calcification.

      Current treatments for lateral epicondylitis include: rest, behaviour modification and
      physiotherapy, anti-inflammatory medication both steroidal and non-steroidal, and surgery.
      Current experimental therapies include muscle relaxants to reduce muscle tone and force on
      the epicondyle, laser therapy to stimulate collagen production, and blood based therapies
      including the injection of autologous blood and protein rich plasma. Trials of the latter two
      treatments give conflicting results due to variations in protocol and trial design.

      Cell Therapy Ltd has developed a regenerative gel, Tendoncel, that combines isolated platelet
      growth factors and cellulose-derivative gel. Tendoncel consists of a proprietary platelet
      lysate formulation that is easy to apply to the skin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
time frame: Baseline
description: 15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
time frame: Day 23 (end of treatment).
description: 15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
time frame: 4 weeks follow up
description: 15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
time frame: 6 weeks follow up.
description: 15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
time frame: 3 months follow up.
description: 15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
time frame: Mean of 47 weeks follow up.
description: 15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
time frame: Baseline
description: 30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
time frame: Day 23.
description: 30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
time frame: 4 week follow up.
description: 30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
time frame: 6 week follow up.
description: 30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
time frame: 3 months follow up
description: 30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
time frame: Mean of 47 weeks follow up.
description: 30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
measure: Pain free grip strength
time frame: Baseline
description: Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
measure: Pain free grip strength
time frame: Day 23
description: Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
measure: Pain free grip strength
time frame: Mean of 47 weeks follow up (final follow up).
description: Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
measure: Safety - Number of participants in each group with adverse events.
time frame: Day 3 (1st treatment visit), day 7, day 14, day 21, day 23 (end of treatment). Follow ups: 4 weeks, 6 weeks, 3 months and mean of 47 weeks.
description: Measured by participant questionnaire. Comparison of the number of participants in each group with cutaneous events - "redness", "rash", "swelling" or changes at gel site. Classed as none, mild, moderate or severe. Plus any other event mentioned by the participants.
measure: Safety: Immune response - blood IgE levels. Difference between test and control groups.
time frame: Baseline
description: Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.
measure: Safety: Immune response - blood IgE levels. Difference between test and control groups.
time frame: Day 7
description: Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.
measure: Safety: Immune response - blood IgE levels. Difference between test and control groups.
time frame: Day 23
description: Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.
measure: Safety: Immune response - blood IgE levels. Number of participants in each group with a normal baseline reading and a subsequently elevated reading.
time frame: Baseline, day 7 and day 23.
description: Measurement of blood IgE levels. Comparison of the number of participants in each group, test and control, with a normal baseline reading of blood IgE and a subsequently elevated IgE reading. Normal is <100IU/mL.
arm group label: Tendoncel
arm group type: Experimental
description: Topically applied experimental gel - Tendoncel. 80ul applied once a day for 21 consecutive days.
arm group label: Placebo control gel
arm group type: Placebo Comparator
description: Placebo control gel. Similar to Tendoncel but without platelet derived small molecules and growth factors. 80ul applied once a day for 21 consecutive days.
intervention type: Biological
intervention name: Tendoncel
description: Platelet lysate gel
arm group label: Tendoncel
intervention type: Other
intervention name: Placebo control gel
description: Placebo control gel
arm group label: Placebo control gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Givissis Panagiotis, MD
role: Principal Investigator
affiliation: Aristotle University of Thessaloniki, General Hospital of Papanikolaou
facility: 
country: Greece
url: https://online.boneandjoint.org.uk/doi/pdf/10.1302/0301-620X.95B9.29285
description: Ahmad et al., (2013)
citation: Ahmad Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Rushton N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013 Sep;95-B(9):1158-64. doi: 10.1302/0301-620X.95B9.29285.
PMID: 23997125
responsible party type: Sponsor
mesh term: Tennis Elbow
sharing ipd: No