<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/NCT03234673</url>
  </required_header>
  <id_info>
    <org_study_id>TEOPFCLEWTCOWNITTOSGV</org_study_id>
    <nct_id>NCT03234673</nct_id>
  </id_info>
  <brief_title>The Effect of Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or NB-UVB in Stable Generalized Vitiligo</brief_title>
  <official_title>The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well&#xD;
      circumscribed depigmented macules and patches that occur secondary to selective destruction&#xD;
      of melanocytes (Zhang et al., 2009).&#xD;
&#xD;
      Generalized vitiligo is the most common clinical presentation and often involves the face and&#xD;
      acral regions (Alikhan et al., 2011).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Combined vitiligo treatments have been found to be superior to monotherapies regarding&#xD;
      efficacy, early response and safety (Kandaswamy et al., 2013).&#xD;
&#xD;
      Fractionated lasers represent a new modality for skin resurfacing based on the theory of&#xD;
      fractional photothermolysis introduced by Manstein et al (2004). These lasers were shown to&#xD;
      be efficient in treating facial photo aging changes as well as scars, and have an improved&#xD;
      safety and recovery profile compared with traditional CO2 laser resurfacing. Fractionated&#xD;
      lasers do not ablate the entire epidermis and thereafter leave intact skin between coagulated&#xD;
      necrotic columns. This characteristic facilitates the skin healing process (Bogdan et al.,&#xD;
      2010)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <phase>Phase 1</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016).</measure>
    <time_frame>up to 3 months</time_frame>
    <description>G0, &lt; 25% repigmentation (poor)&#xD;
G1, 25-50% repigmentation (fair)&#xD;
G2, 50-75% repigmentation (good)&#xD;
G3 &gt; 75% repigmentation (excellent).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The VASI percent change</measure>
    <time_frame>every month for 3 months</time_frame>
    <description>The VASI percent change will be calculated by subtracting the pre- procedure VASI score from the post-procedure VASI score and dividing by the pre-procedure VASI score.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>- Frequency and types of side effects.</measure>
    <time_frame>3 months</time_frame>
    <description>pain, scarring, hyperpigmentation</description>
  </other_outcome>
  <other_outcome>
    <measure>- Patient satisfaction. The patient overall satisfaction will be assessed after 6 months according to Wong and Vasconez (2011). Overall satisfaction:</measure>
    <time_frame>3 months</time_frame>
    <description>dissatisfied&#xD;
neutral&#xD;
somewhat satisfied&#xD;
moderately satisfied&#xD;
very satisfied</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Vitiligo Vulgaris</condition>
  <arm_group>
    <arm_group_label>Group A (Tacrolimus group):</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fractional CO2 laser therapy and Tacrolimus ointment 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (Calcipotriol group):</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fractional CO2 laser therapy and Calcipotriol ointment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C (NB-UVB group):</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fractional CO2 laser therapy and NB-UVB twice weekly</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tacrolimus ointment</intervention_name>
    <description>3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months.</description>
    <arm_group_label>Group A (Tacrolimus group):</arm_group_label>
    <other_name>tarolimus ointment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>calcipotriol ointment</intervention_name>
    <description>3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months.</description>
    <arm_group_label>Group B (Calcipotriol group):</arm_group_label>
    <other_name>calcipoheal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NB-UVB</intervention_name>
    <description>3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months</description>
    <arm_group_label>Group C (NB-UVB group):</arm_group_label>
    <other_name>narrow band ultraviolet rays B</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with stable vitiligo&#xD;
&#xD;
          -  nonsegmental vitiligo will be recruited&#xD;
&#xD;
          -  A patient reporting no new lesions, no progression of existing lesions, and absence of&#xD;
             Koebner phenomenon during the previous year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with active infection.&#xD;
&#xD;
          2. Reported histories of koebnerization.&#xD;
&#xD;
          3. History of keloid formation or hypertrophic scars.&#xD;
&#xD;
          4. Pregnant or lactating females.&#xD;
&#xD;
          5. Bleeding tendency.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>yasmin tawfik, MD</last_name>
    <phone>01006033331</phone>
    <email>dr.yasminmostawfik@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>reham maher abdel gaber</last_name>
    <phone>01005043777</phone>
    <email>rehamaher707@yahoo.com</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.</citation>
    <PMID>25596811</PMID>
  </results_reference>
  <results_reference>
    <citation>Kandaswamy S, Akhtar N, Ravindran S, Prabhu S, Shenoi SD. Phototherapy in Vitiligo: Assessing the Compliance, Response and Patient's Perception about Disease and Treatment. Indian J Dermatol. 2013 Jul;58(4):325. doi: 10.4103/0019-5154.113944.</citation>
    <PMID>23919018</PMID>
  </results_reference>
  <results_reference>
    <citation>Bogdan Allemann I, Kaufman J. Fractional photothermolysis--an update. Lasers Med Sci. 2010 Jan;25(1):137-44. doi: 10.1007/s10103-009-0734-8.</citation>
    <PMID>19787413</PMID>
  </results_reference>
  <results_reference>
    <citation>Wong L, Vasconez HC. Patient satisfaction after Nd:YAG laser-assisted lipolysis. Ann Plast Surg. 2011 May;66(5):561-3. doi: 10.1097/SAP.0b013e31820b3d1e.</citation>
    <PMID>21451378</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 30, 2017</last_update_submitted>
  <last_update_submitted_qc>July 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Yasmin Mostafa Tawfik</investigator_full_name>
    <investigator_title>clinical professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitiligo</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcipotriene</mesh_term>
    <mesh_term>Tacrolimus</mesh_term>
  </intervention_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/NCT03234673
org study id: TEOPFCLEWTCOWNITTOSGV
nct id: NCT03234673
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well
      circumscribed depigmented macules and patches that occur secondary to selective destruction
      of melanocytes (Zhang et al., 2009).

      Generalized vitiligo is the most common clinical presentation and often involves the face and
      acral regions (Alikhan et al., 2011).
Combined vitiligo treatments have been found to be superior to monotherapies regarding
      efficacy, early response and safety (Kandaswamy et al., 2013).

      Fractionated lasers represent a new modality for skin resurfacing based on the theory of
      fractional photothermolysis introduced by Manstein et al (2004). These lasers were shown to
      be efficient in treating facial photo aging changes as well as scars, and have an improved
      safety and recovery profile compared with traditional CO2 laser resurfacing. Fractionated
      lasers do not ablate the entire epidermis and thereafter leave intact skin between coagulated
      necrotic columns. This characteristic facilitates the skin healing process (Bogdan et al.,
      2010)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016).
time frame: up to 3 months
description: G0, < 25% repigmentation (poor)
G1, 25-50% repigmentation (fair)
G2, 50-75% repigmentation (good)
G3 > 75% repigmentation (excellent).
measure: The VASI percent change
time frame: every month for 3 months
description: The VASI percent change will be calculated by subtracting the pre- procedure VASI score from the post-procedure VASI score and dividing by the pre-procedure VASI score.
measure: - Frequency and types of side effects.
time frame: 3 months
description: pain, scarring, hyperpigmentation
measure: - Patient satisfaction. The patient overall satisfaction will be assessed after 6 months according to Wong and Vasconez (2011). Overall satisfaction:
time frame: 3 months
description: dissatisfied
neutral
somewhat satisfied
moderately satisfied
very satisfied
arm group label: Group A (Tacrolimus group):
arm group type: Experimental
description: fractional CO2 laser therapy and Tacrolimus ointment 1
arm group label: Group B (Calcipotriol group):
arm group type: Experimental
description: fractional CO2 laser therapy and Calcipotriol ointment
arm group label: Group C (NB-UVB group):
arm group type: Experimental
description: fractional CO2 laser therapy and NB-UVB twice weekly
intervention type: Drug
intervention name: Tacrolimus ointment
description: 3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months.
arm group label: Group A (Tacrolimus group):
other name: tarolimus ointment
intervention type: Drug
intervention name: calcipotriol ointment
description: 3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months.
arm group label: Group B (Calcipotriol group):
other name: calcipoheal
intervention type: Drug
intervention name: NB-UVB
description: 3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months
arm group label: Group C (NB-UVB group):
other name: narrow band ultraviolet rays B
criteria: 
gender: All
minimum age: 12 Years
maximum age: 60 Years
healthy volunteers: No
last name: yasmin tawfik, MD
phone: 01006033331
email: dr.yasminmostawfik@yahoo.com
last name: reham maher abdel gaber
phone: 01005043777
email: rehamaher707@yahoo.com
citation: Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.
PMID: 25596811
citation: Kandaswamy S, Akhtar N, Ravindran S, Prabhu S, Shenoi SD. Phototherapy in Vitiligo: Assessing the Compliance, Response and Patient's Perception about Disease and Treatment. Indian J Dermatol. 2013 Jul;58(4):325. doi: 10.4103/0019-5154.113944.
PMID: 23919018
citation: Bogdan Allemann I, Kaufman J. Fractional photothermolysis--an update. Lasers Med Sci. 2010 Jan;25(1):137-44. doi: 10.1007/s10103-009-0734-8.
PMID: 19787413
citation: Wong L, Vasconez HC. Patient satisfaction after Nd:YAG laser-assisted lipolysis. Ann Plast Surg. 2011 May;66(5):561-3. doi: 10.1097/SAP.0b013e31820b3d1e.
PMID: 21451378
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Yasmin Mostafa Tawfik
investigator title: clinical professor
mesh term: Vitiligo
mesh term: Calcipotriene
mesh term: Tacrolimus
sharing ipd: Undecided