xml: <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/NCT06003062</url>
    </required_header>
    <id_info>
      <org_study_id>Lip Hair Growth Suppression</org_study_id>
      <nct_id>NCT06003062</nct_id>
    </id_info>
    <brief_title>Suppression of Upper Lip Hair Growth Using Novel Hemp Extract</brief_title>
    <official_title>Suppression of Upper Lip Hair Growth Using Novel Hemp Extract - A Case Series</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical Life Care Planners, LLC</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical Life Care Planners, LLC</source>
    <oversight_info>
      <has_dmc>Yes</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>
        A clinical case series will be conducted measuring upper lip hair suppression for cosmetic&#xD;
        effects in a group of 25 adult women with hirsutism of the upper lip. The study will use a&#xD;
        topical phytonutraceutical that contains two ingredients that have been shown to suppress&#xD;
        hair growth. The serum contains Narcissus Tazetta Bulb Extract (0.2%) and a hemp-extract&#xD;
        (0.15%) known to stimulate cannabinoid one (CB1) receptors.&#xD;
  &#xD;
        The subjects will use the serum nightly for 60 days. High-power ProScope photographs will be&#xD;
        obtained at the philtrum (above the center of the upper lip) as a landmark. Prior to starting&#xD;
        the serum subjects will grow their upper lip hair for seven days. Hair shafts will be counted&#xD;
        and graded for thickness and color using a standard methodology. The subjects will then use&#xD;
        the serum for 60 days and will not be allowed to use laser, waxing, bleaching or tweezing&#xD;
        during the duration of the study. Only shaving will be allowed. At the end of the 60 day&#xD;
        course the subjects will grow their lip hair for seven days and the high-power photographs&#xD;
        will be repeated at the same location based on landmarks.&#xD;
  &#xD;
        An independent board-certified dermatologist will evaluate and grade the pre- and post- serum&#xD;
        photographs for cosmetic effects, number and thickness of the hairs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hirsutism is defined as increased bodily and facial hair growth in females presenting in&#xD;
        locations where hair is ordinarily minimal or absent. It affects almost 30% of adult females&#xD;
        during their lifetime. Current treatments for hirsutism include the use of oral&#xD;
        contraceptives or antiandrogens. These drugs and hormones are associated with adverse effects&#xD;
        and they may not manifest results if at all for at least 6 months most cannot be used if the&#xD;
        female is pregnant, breastfeeding, or trying to become pregnant. Many women find that a&#xD;
        multipronged approach that includes direct hair removal (such as plucking, waxing, shaving,&#xD;
        depilatories, bleaches and laser), suppression of androgen production with drugs. More&#xD;
        recently an effective prescription topical cream, Eflornithine hydrochloride (brand name:&#xD;
        Vaniqa) has become available to slow the growth of unwanted facial hair in women. It does not&#xD;
        remove hair permanently. Noticeable results take approximately six to eight weeks, and once&#xD;
        the cream is discontinued, hair returns to pretreatment levels after approximately eight&#xD;
        weeks. Eflornithine cream may cause skin to redden.&#xD;
  &#xD;
        Narcissus Tarzetta Bulb Extract 0.02% IBR-Dormin applied topically reduced hair shaft&#xD;
        elongation by 34%. The test also showed the hair follicle started the transition from growth&#xD;
        to resting phase (telogen). A study of 3.0% topical extract revealed a delay of men's facial&#xD;
        hair regrowth after shaving.&#xD;
  &#xD;
        Studies of endocannabinoids and phytocannabinoids that stimulate the cannabinoid one (CB1)&#xD;
        receptor reveal that topical application inhibited hair shaft elongation and the&#xD;
        proliferation of hair matrix keratinocytes, and induced intraepithelial apoptosis and&#xD;
        premature hair follicle regression (catagen).&#xD;
  &#xD;
        A clinical case series from serial patients with hirsuitism (adult females) at a dermatology&#xD;
        clinic will be conducted measuring upper lip hair suppression for cosmetic effects and change&#xD;
        in hair shaft count and color. The study will use a topical phytonutraceutical containing&#xD;
        Narcissus Tazetta Bulb Extract (0.2%) and a hemp-extract (0.15%) known to stimulate&#xD;
        cannabinoid one (CB1) receptors. Based on prior studies the topical will work locally as a&#xD;
        locally active topical without systemic absorption.&#xD;
  &#xD;
        The 25 subjects will use the serum nightly for 60 days. High-power ProScope photographs will&#xD;
        be obtained at the philtrum (above the center of the upper lip) as a landmark. Prior to&#xD;
        starting the serum subjects will grow their upper lip hair for seven days. Hair shafts will&#xD;
        be counted and graded for thickness and color using a standard methodology. The subjects will&#xD;
        then use the serum for 60 days and will not be allowed to use laser, waxing, depilatories,&#xD;
        bleaching or tweezing during the duration of the study. Only shaving will be allowed. At the&#xD;
        end of the 60-day trial the subjects will grow their lip hair for seven days and the&#xD;
        high-power photographs will be repeated at the same location based on landmarks.&#xD;
  &#xD;
        An independent board-certified dermatologist will evaluate and grade the pre- and&#xD;
        post-treatment photographs for cosmetic effects, number and thickness of the hairs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Hair Follicle Number</measure>
      <time_frame>60 days</time_frame>
      <description>The change in the number of identifable hair follicles using high-power ProScope</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hair Follicle Diameter</measure>
      <time_frame>60 days</time_frame>
      <description>The change in the hair average hair follicle diameter using high-power ProScope</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hair Shaft Color</measure>
      <time_frame>60 days</time_frame>
      <description>The change in the darkness of the hair follicles will be measured using high-power ProScope</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Hirsutism</condition>
    <condition>Hair Diseases</condition>
    <arm_group>
      <arm_group_label>Standard Topical NIghtly Dose</arm_group_label>
      <description>Treatment group</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Narcissus Tazetta Bulb Extract and Novel Hemp Extract</intervention_name>
      <description>Topical nightly application of phytonutraceutical</description>
      <arm_group_label>Standard Topical NIghtly Dose</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult women with physician-diagnosed hirsutism presenting to a dermatology clinic.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Physician diagnosed upper lip hirsutism Prior use of therapies to treat the upper lip&#xD;
          hirsutism No laser, depilation, or waxing within prior 8 weeks -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Local infection near or at application site. Local skin irritation or ulceration near or at&#xD;
          application site. Inability to be available for entire duration of study and in-person&#xD;
          photographs&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Adult women</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Gregory L Smith, MD</last_name>
      <phone>4044514045</phone>
      <email>DrSmith@NeX-Therapeutics.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shannon Powell, TTS</last_name>
      <phone>8132402369</phone>
      <email>Shannon@NeX-Therapeutics.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Kopera D, Wehr E, Obermayer-Pietsch B. Endocrinology of hirsutism. Int J Trichology. 2010 Jan;2(1):30-5. doi: 10.4103/0974-7753.66910.</citation>
      <PMID>21188021</PMID>
    </reference>
    <reference>
      <citation>Gupta AK, Talukder M. Cannabinoids for skin diseases and hair regrowth. J Cosmet Dermatol. 2021 Sep;20(9):2703-2711. doi: 10.1111/jocd.14352. Epub 2021 Aug 7.</citation>
      <PMID>34363728</PMID>
    </reference>
    <reference>
      <citation>Barrionuevo P, Nabhan M, Altayar O, Wang Z, Erwin PJ, Asi N, Martin KA, Murad MH. Treatment Options for Hirsutism: A Systematic Review and Network Meta-Analysis. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1258-1264. doi: 10.1210/jc.2017-02052.</citation>
      <PMID>29522176</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical Life Care Planners, LLC</investigator_affiliation>
      <investigator_full_name>Gregory L Smith, MD, MPH</investigator_full_name>
      <investigator_title>Principal Investigaor</investigator_title>
    </responsible_party>
    <keyword>Narcissus Tarzetta Bulb Extract</keyword>
    <keyword>Cannabinoid One (CB1) receptor</keyword>
    <keyword>IBR-Dormin</keyword>
    <keyword>Hemp-extract</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hirsutism</mesh_term>
      <mesh_term>Hair Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06003062
  org study id: Lip Hair Growth Suppression
  nct id: NCT06003062
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A clinical case series will be conducted measuring upper lip hair suppression for cosmetic
        effects in a group of 25 adult women with hirsutism of the upper lip. The study will use a
        topical phytonutraceutical that contains two ingredients that have been shown to suppress
        hair growth. The serum contains Narcissus Tazetta Bulb Extract (0.2%) and a hemp-extract
        (0.15%) known to stimulate cannabinoid one (CB1) receptors.
  
        The subjects will use the serum nightly for 60 days. High-power ProScope photographs will be
        obtained at the philtrum (above the center of the upper lip) as a landmark. Prior to starting
        the serum subjects will grow their upper lip hair for seven days. Hair shafts will be counted
        and graded for thickness and color using a standard methodology. The subjects will then use
        the serum for 60 days and will not be allowed to use laser, waxing, bleaching or tweezing
        during the duration of the study. Only shaving will be allowed. At the end of the 60 day
        course the subjects will grow their lip hair for seven days and the high-power photographs
        will be repeated at the same location based on landmarks.
  
        An independent board-certified dermatologist will evaluate and grade the pre- and post- serum
        photographs for cosmetic effects, number and thickness of the hairs.
  Hirsutism is defined as increased bodily and facial hair growth in females presenting in
        locations where hair is ordinarily minimal or absent. It affects almost 30% of adult females
        during their lifetime. Current treatments for hirsutism include the use of oral
        contraceptives or antiandrogens. These drugs and hormones are associated with adverse effects
        and they may not manifest results if at all for at least 6 months most cannot be used if the
        female is pregnant, breastfeeding, or trying to become pregnant. Many women find that a
        multipronged approach that includes direct hair removal (such as plucking, waxing, shaving,
        depilatories, bleaches and laser), suppression of androgen production with drugs. More
        recently an effective prescription topical cream, Eflornithine hydrochloride (brand name:
        Vaniqa) has become available to slow the growth of unwanted facial hair in women. It does not
        remove hair permanently. Noticeable results take approximately six to eight weeks, and once
        the cream is discontinued, hair returns to pretreatment levels after approximately eight
        weeks. Eflornithine cream may cause skin to redden.
  
        Narcissus Tarzetta Bulb Extract 0.02% IBR-Dormin applied topically reduced hair shaft
        elongation by 34%. The test also showed the hair follicle started the transition from growth
        to resting phase (telogen). A study of 3.0% topical extract revealed a delay of men's facial
        hair regrowth after shaving.
  
        Studies of endocannabinoids and phytocannabinoids that stimulate the cannabinoid one (CB1)
        receptor reveal that topical application inhibited hair shaft elongation and the
        proliferation of hair matrix keratinocytes, and induced intraepithelial apoptosis and
        premature hair follicle regression (catagen).
  
        A clinical case series from serial patients with hirsuitism (adult females) at a dermatology
        clinic will be conducted measuring upper lip hair suppression for cosmetic effects and change
        in hair shaft count and color. The study will use a topical phytonutraceutical containing
        Narcissus Tazetta Bulb Extract (0.2%) and a hemp-extract (0.15%) known to stimulate
        cannabinoid one (CB1) receptors. Based on prior studies the topical will work locally as a
        locally active topical without systemic absorption.
  
        The 25 subjects will use the serum nightly for 60 days. High-power ProScope photographs will
        be obtained at the philtrum (above the center of the upper lip) as a landmark. Prior to
        starting the serum subjects will grow their upper lip hair for seven days. Hair shafts will
        be counted and graded for thickness and color using a standard methodology. The subjects will
        then use the serum for 60 days and will not be allowed to use laser, waxing, depilatories,
        bleaching or tweezing during the duration of the study. Only shaving will be allowed. At the
        end of the 60-day trial the subjects will grow their lip hair for seven days and the
        high-power photographs will be repeated at the same location based on landmarks.
  
        An independent board-certified dermatologist will evaluate and grade the pre- and
        post-treatment photographs for cosmetic effects, number and thickness of the hairs.
  observational model: Case-Only
  time perspective: Prospective
  measure: Hair Follicle Number
  time frame: 60 days
  description: The change in the number of identifable hair follicles using high-power ProScope
  measure: Hair Follicle Diameter
  time frame: 60 days
  description: The change in the hair average hair follicle diameter using high-power ProScope
  measure: Hair Shaft Color
  time frame: 60 days
  description: The change in the darkness of the hair follicles will be measured using high-power ProScope
  arm group label: Standard Topical NIghtly Dose
  description: Treatment group
  intervention type: Drug
  intervention name: Narcissus Tazetta Bulb Extract and Novel Hemp Extract
  description: Topical nightly application of phytonutraceutical
  arm group label: Standard Topical NIghtly Dose
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Adult women
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gregory L Smith, MD
  phone: 4044514045
  email: DrSmith@NeX-Therapeutics.com
  last name: Shannon Powell, TTS
  phone: 8132402369
  email: Shannon@NeX-Therapeutics.com
  citation: Kopera D, Wehr E, Obermayer-Pietsch B. Endocrinology of hirsutism. Int J Trichology. 2010 Jan;2(1):30-5. doi: 10.4103/0974-7753.66910.
  PMID: 21188021
  citation: Gupta AK, Talukder M. Cannabinoids for skin diseases and hair regrowth. J Cosmet Dermatol. 2021 Sep;20(9):2703-2711. doi: 10.1111/jocd.14352. Epub 2021 Aug 7.
  PMID: 34363728
  citation: Barrionuevo P, Nabhan M, Altayar O, Wang Z, Erwin PJ, Asi N, Martin KA, Murad MH. Treatment Options for Hirsutism: A Systematic Review and Network Meta-Analysis. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1258-1264. doi: 10.1210/jc.2017-02052.
  PMID: 29522176
  responsible party type: Principal Investigator
  investigator affiliation: Medical Life Care Planners, LLC
  investigator full name: Gregory L Smith, MD, MPH
  investigator title: Principal Investigaor
  mesh term: Hirsutism
  mesh term: Hair Diseases
  sharing ipd: Undecided