<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/NCT04403282</url>
  </required_header>
  <id_info>
    <org_study_id>WRNMMC-2020-0298</org_study_id>
    <nct_id>NCT04403282</nct_id>
  </id_info>
  <brief_title>Topical Eflornithine for Pseudofolliculitis Barbae: RCT</brief_title>
  <official_title>Topical Eflornithine Hydrochloride for Pseudofolliculitis Barbae: A Randomized, Double-blinded, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Walter Reed National Military Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Walter Reed National Military Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the efficacy of topical eflornithine for pseudofolliculitis barbae from a quality of&#xD;
      life standpoint and with objective physician-measured lesion counts. Our hypothesis is that&#xD;
      the hair growth retardation that occurs with eflornithine will perhaps reduce the frequency&#xD;
      over time that service members need to shave which could improve the formation of PFB&#xD;
      lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pseudofolliculitis barbae (PFB), or 'ingrown hairs,' is a common skin disease of the face and&#xD;
      neck caused by shaving in predisposed individuals who have naturally curly hair. It affects a&#xD;
      disproportionate number of African American Service Members - up to 45% in one&#xD;
      study.(Alexander, 1974) Keeping a close shave is a requirement for service in all of the&#xD;
      Unites States armed services, and as a result, PFB is a major cause of morbidity in this&#xD;
      population. The main rationale behind this policy is that a beard prevents a proper seal when&#xD;
      using breathing protection devices, in particular gas masks. A review of various dermatologic&#xD;
      conditions seen in wartime found that the incidence of PFB was 5.9% during the Vietnam War&#xD;
      and 1.8% during Operation Iraqi Freedom (OIF) (Gelman, 2015). The authors argued that this&#xD;
      was due to a relaxing of the shaving standards as part of the update PFB protocol followed&#xD;
      during OIF. However, the United States Navy recently announced a change to their PFB&#xD;
      protocol, discontinuing the issuance of permanent &quot;no-shave&quot; chits. Laser hair removal (LHR)&#xD;
      using the Nd:YAG laser is the current treatment of choice for the majority of patients who&#xD;
      fail conservative treatment with topical retinoids, antibiotics, and optimization of shaving&#xD;
      practices. However, LHR treatment can induce a permanent change in facial hair density and&#xD;
      patients treated with this modality may have to accept a permanent change in their ability to&#xD;
      grow a beard. In addition, laser treatments have a potential for operative discomfort along&#xD;
      with blistering and dyspigmentation of skin. Eflornithine is a topical medication that is FDA&#xD;
      indicated for the treatment of unwanted terminal hairs in women. It works by its action as an&#xD;
      irreversible inhibitor of ornithine decarboxylase, an enzyme responsible for the formation of&#xD;
      polyamines which allow for various proliferative activities in the skin. It is the only known&#xD;
      topical treatment that can retard the growth of human hair. Xia et al. showed that this&#xD;
      medication can be used in conjunction with LHR to enhance the efficacy of the treatment for&#xD;
      PFB(Xia, 2012). However, there are no studies to date that look at eflornithine as&#xD;
      monotherapy for the treatment of PFB. The Unites States Navy has included topical&#xD;
      eflornithine as a potential PFB treatment in their latest Bureau of Medicine and Surgery&#xD;
      (BUMED) instruction despite the lack of evidence behind its use. If shown to be efficacious,&#xD;
      this medication would provide a cost-effective treatment for PFB, especially in medical&#xD;
      practices that do not have a hair removal laser. In addition, the effects of eflornithine are&#xD;
      reversible with discontinuation, making it an ideal choice for patients and service members&#xD;
      who would like to retain their ability to grow normal beards.&#xD;
&#xD;
      Goal: To study the efficacy of topical eflornithine for pseudofolliculitis barbae from an&#xD;
      objective physician-measured lesion count. Our hypothesis is that the hair growth retardation&#xD;
      that occurs with eflornithine will perhaps reduce the frequency over time that service&#xD;
      members need to shave which could improve the formation of PFB lesions.&#xD;
&#xD;
      Plan&#xD;
&#xD;
        1. Recruitment of patients that meet inclusion criteria (No LHR treatments in the past&#xD;
           year, Not pregnant or breast feeding).&#xD;
&#xD;
        2. Provide written informed consent.&#xD;
&#xD;
        3. Patients instructed to discontinue all other treatment modalities for PFB (plucking,&#xD;
           waxing, chemical depilatories, topical retinoids).&#xD;
&#xD;
        4. Patients receive two identical 30-g jars from the Walter Reed Army Medical Center&#xD;
           research pharmacist. The jars will be labeled &quot;left&quot; and &quot;right&quot; and randomized by the&#xD;
           pharmacy using a random number generator.&#xD;
&#xD;
        5. Initial lesion counts and Skindex-16 QoL measurements taken. Two (left and right) 2-cm&#xD;
           circles drawn at the junction of the submental chin and anterior neck for the lesion&#xD;
           counts.&#xD;
&#xD;
        6. Patients begin applying a thin layer of each cream corresponding to the site of&#xD;
           application (left and right beard) twice a day.&#xD;
&#xD;
        7. Follow up at 4 week intervals, at which the number of hairs and inflammatory papules&#xD;
           will be counted within the two 2-cm circles on the submental chin by two dermatology&#xD;
           residents or staff dermatologists.&#xD;
&#xD;
        8. Patient then goes to research pharmacist. Pharmacist weighs both eflornithine as well as&#xD;
           placebo cream to measure compliance. Re-issue new 30-g jars.&#xD;
&#xD;
        9. At week 16, final lesions counts administered.&#xD;
&#xD;
       10. Data is analyzed using Wilcoxon signed-rank tests.&#xD;
&#xD;
       11. Findings published.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of skin lesions</measure>
    <time_frame>16 weeks</time_frame>
    <description>number of skin lesions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of hairs</measure>
    <time_frame>16 weeks</time_frame>
    <description>number of hairs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Pseudofolliculitis Barbae</condition>
  <arm_group>
    <arm_group_label>Paired(right and left neck) comparison group eflornithine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paired(right and left neck) comparison group placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eflornithine Topical</intervention_name>
    <description>Subjects will apply placebo to one side of beard and eflornithine to other side for 16 weeks.</description>
    <arm_group_label>Paired(right and left neck) comparison group eflornithine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Eflornithine Topical</intervention_name>
    <description>Subjects will apply placebo to one side of beard and eflornithine to other side for 16 weeks.</description>
    <arm_group_label>Paired(right and left neck) comparison group placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active Duty Service Members with Pseudofolliculitis Barbae&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with laser hair removal in the previous 12 months, Currently&#xD;
             pregnant, seeking pregnancy, or breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sunghun Cho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Walter Reed National Military Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ford Lannan, MD</last_name>
    <phone>301-295-4551</phone>
    <email>ford4040@me.com</email>
  </overall_contact>
  <link>
    <url>https://www.drugs.com/monograph/eflornithine.html</url>
    <description>Eflornithine Monograph for Professionals - Drugs.com.</description>
  </link>
  <reference>
    <citation>Alexander AM, Delph WI. Pseudofolliculitis barbae in the military. A medical, administrative and social problem. J Natl Med Assoc. 1974 Nov;66(6):459-64, 479. No abstract available.</citation>
    <PMID>4436875</PMID>
  </reference>
  <reference>
    <citation>Gelman AB, Norton SA, Valdes-Rodriguez R, Yosipovitch G. A review of skin conditions in modern warfare and peacekeeping operations. Mil Med. 2015 Jan;180(1):32-7. doi: 10.7205/MILMED-D-14-00240.</citation>
    <PMID>25562855</PMID>
  </reference>
  <reference>
    <citation>Ogunbiyi A. Pseudofolliculitis barbae; current treatment options. Clin Cosmet Investig Dermatol. 2019 Apr 16;12:241-247. doi: 10.2147/CCID.S149250. eCollection 2019.</citation>
    <PMID>31354326</PMID>
  </reference>
  <reference>
    <citation>Xia Y, Cho S, Howard RS, Maggio KL. Topical eflornithine hydrochloride improves the effectiveness of standard laser hair removal for treating pseudofolliculitis barbae: a randomized, double-blinded, placebo-controlled trial. J Am Acad Dermatol. 2012 Oct;67(4):694-9. doi: 10.1016/j.jaad.2011.10.029. Epub 2012 Jan 9.</citation>
    <PMID>22226431</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pseudofolliculitis Barbae</keyword>
  <keyword>Eflornithine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hair Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eflornithine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The PI will compile the names of the patients who are followed through week 16 in order to create the master subject list. Using the information stored on the master subject list (name, SSN, Medical Record Number), the research team will obtain data electronically from the patient medical records. Specifically, the lesion and hair counts on the face will be acquired. This will be recorded on the master data sheet. The master subject list will be password protected and only accessible to study personnel within the Walter Reed National Military Medical Center (WRNMMC) network. The master data sheet will be coded and available to the investigators and may be shared with research assistants or statisticians.</ipd_description>
  </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/NCT04403282
org study id: WRNMMC-2020-0298
nct id: NCT04403282
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To study the efficacy of topical eflornithine for pseudofolliculitis barbae from a quality of
      life standpoint and with objective physician-measured lesion counts. Our hypothesis is that
      the hair growth retardation that occurs with eflornithine will perhaps reduce the frequency
      over time that service members need to shave which could improve the formation of PFB
      lesions.
Pseudofolliculitis barbae (PFB), or 'ingrown hairs,' is a common skin disease of the face and
      neck caused by shaving in predisposed individuals who have naturally curly hair. It affects a
      disproportionate number of African American Service Members - up to 45% in one
      study.(Alexander, 1974) Keeping a close shave is a requirement for service in all of the
      Unites States armed services, and as a result, PFB is a major cause of morbidity in this
      population. The main rationale behind this policy is that a beard prevents a proper seal when
      using breathing protection devices, in particular gas masks. A review of various dermatologic
      conditions seen in wartime found that the incidence of PFB was 5.9% during the Vietnam War
      and 1.8% during Operation Iraqi Freedom (OIF) (Gelman, 2015). The authors argued that this
      was due to a relaxing of the shaving standards as part of the update PFB protocol followed
      during OIF. However, the United States Navy recently announced a change to their PFB
      protocol, discontinuing the issuance of permanent "no-shave" chits. Laser hair removal (LHR)
      using the Nd:YAG laser is the current treatment of choice for the majority of patients who
      fail conservative treatment with topical retinoids, antibiotics, and optimization of shaving
      practices. However, LHR treatment can induce a permanent change in facial hair density and
      patients treated with this modality may have to accept a permanent change in their ability to
      grow a beard. In addition, laser treatments have a potential for operative discomfort along
      with blistering and dyspigmentation of skin. Eflornithine is a topical medication that is FDA
      indicated for the treatment of unwanted terminal hairs in women. It works by its action as an
      irreversible inhibitor of ornithine decarboxylase, an enzyme responsible for the formation of
      polyamines which allow for various proliferative activities in the skin. It is the only known
      topical treatment that can retard the growth of human hair. Xia et al. showed that this
      medication can be used in conjunction with LHR to enhance the efficacy of the treatment for
      PFB(Xia, 2012). However, there are no studies to date that look at eflornithine as
      monotherapy for the treatment of PFB. The Unites States Navy has included topical
      eflornithine as a potential PFB treatment in their latest Bureau of Medicine and Surgery
      (BUMED) instruction despite the lack of evidence behind its use. If shown to be efficacious,
      this medication would provide a cost-effective treatment for PFB, especially in medical
      practices that do not have a hair removal laser. In addition, the effects of eflornithine are
      reversible with discontinuation, making it an ideal choice for patients and service members
      who would like to retain their ability to grow normal beards.

      Goal: To study the efficacy of topical eflornithine for pseudofolliculitis barbae from an
      objective physician-measured lesion count. Our hypothesis is that the hair growth retardation
      that occurs with eflornithine will perhaps reduce the frequency over time that service
      members need to shave which could improve the formation of PFB lesions.

      Plan

        1. Recruitment of patients that meet inclusion criteria (No LHR treatments in the past
           year, Not pregnant or breast feeding).

        2. Provide written informed consent.

        3. Patients instructed to discontinue all other treatment modalities for PFB (plucking,
           waxing, chemical depilatories, topical retinoids).

        4. Patients receive two identical 30-g jars from the Walter Reed Army Medical Center
           research pharmacist. The jars will be labeled "left" and "right" and randomized by the
           pharmacy using a random number generator.

        5. Initial lesion counts and Skindex-16 QoL measurements taken. Two (left and right) 2-cm
           circles drawn at the junction of the submental chin and anterior neck for the lesion
           counts.

        6. Patients begin applying a thin layer of each cream corresponding to the site of
           application (left and right beard) twice a day.

        7. Follow up at 4 week intervals, at which the number of hairs and inflammatory papules
           will be counted within the two 2-cm circles on the submental chin by two dermatology
           residents or staff dermatologists.

        8. Patient then goes to research pharmacist. Pharmacist weighs both eflornithine as well as
           placebo cream to measure compliance. Re-issue new 30-g jars.

        9. At week 16, final lesions counts administered.

       10. Data is analyzed using Wilcoxon signed-rank tests.

       11. Findings published.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: number of skin lesions
time frame: 16 weeks
description: number of skin lesions
measure: number of hairs
time frame: 16 weeks
description: number of hairs
arm group label: Paired(right and left neck) comparison group eflornithine
arm group type: Active Comparator
description: randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB.
arm group label: Paired(right and left neck) comparison group placebo
arm group type: Placebo Comparator
description: randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB.
intervention type: Drug
intervention name: Eflornithine Topical
description: Subjects will apply placebo to one side of beard and eflornithine to other side for 16 weeks.
arm group label: Paired(right and left neck) comparison group eflornithine
intervention type: Drug
intervention name: Placebo Eflornithine Topical
description: Subjects will apply placebo to one side of beard and eflornithine to other side for 16 weeks.
arm group label: Paired(right and left neck) comparison group placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sunghun Cho, MD
role: Principal Investigator
affiliation: Walter Reed National Military Medical Center
last name: Ford Lannan, MD
phone: 301-295-4551
email: ford4040@me.com
url: https://www.drugs.com/monograph/eflornithine.html
description: Eflornithine Monograph for Professionals - Drugs.com.
citation: Alexander AM, Delph WI. Pseudofolliculitis barbae in the military. A medical, administrative and social problem. J Natl Med Assoc. 1974 Nov;66(6):459-64, 479. No abstract available.
PMID: 4436875
citation: Gelman AB, Norton SA, Valdes-Rodriguez R, Yosipovitch G. A review of skin conditions in modern warfare and peacekeeping operations. Mil Med. 2015 Jan;180(1):32-7. doi: 10.7205/MILMED-D-14-00240.
PMID: 25562855
citation: Ogunbiyi A. Pseudofolliculitis barbae; current treatment options. Clin Cosmet Investig Dermatol. 2019 Apr 16;12:241-247. doi: 10.2147/CCID.S149250. eCollection 2019.
PMID: 31354326
citation: Xia Y, Cho S, Howard RS, Maggio KL. Topical eflornithine hydrochloride improves the effectiveness of standard laser hair removal for treating pseudofolliculitis barbae: a randomized, double-blinded, placebo-controlled trial. J Am Acad Dermatol. 2012 Oct;67(4):694-9. doi: 10.1016/j.jaad.2011.10.029. Epub 2012 Jan 9.
PMID: 22226431
responsible party type: Sponsor
mesh term: Hair Diseases
mesh term: Eflornithine
sharing ipd: No
ipd description: The PI will compile the names of the patients who are followed through week 16 in order to create the master subject list. Using the information stored on the master subject list (name, SSN, Medical Record Number), the research team will obtain data electronically from the patient medical records. Specifically, the lesion and hair counts on the face will be acquired. This will be recorded on the master data sheet. The master subject list will be password protected and only accessible to study personnel within the Walter Reed National Military Medical Center (WRNMMC) network. The master data sheet will be coded and available to the investigators and may be shared with research assistants or statisticians.