<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/NCT04435847</url>
  </required_header>
  <id_info>
    <org_study_id>HST 001-AES-003-HG</org_study_id>
    <nct_id>NCT04435847</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of HST 001 in Male Pattern Hair Loss</brief_title>
  <official_title>Phase 1b, Double-Blind, Placebo-controlled Study of Safety and Efficacy of HST 001 in Male Subjects With Male Pattern Hair Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Histogen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Histogen</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      HST 001 (also known as hair stimulating complex [HSC]) is a mixture of growth factors&#xD;
      secreted by human dermal fibroblasts when cultured in proprietary bioreactors which are then&#xD;
      harvested and concentrated to specific ranges. In both preclinical studies and in previous&#xD;
      clinical trials, HSC has been shown to be safe, with no serious adverse events reported. This&#xD;
      protocol design is based on the completed Phase 1 study in women which used a similar&#xD;
      investigational product (Study 16-HIS002-US; HSC660), and includes specific objective&#xD;
      efficacy endpoints (macrophotography) to measure Target Area Hair Counts (TAHC) after three&#xD;
      separate doses of product separated by six weeks (week 0, week 6, week 12) and comparing to&#xD;
      placebo treated group&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Single center, randomized, controlled, parallel-design study in participants with mild&#xD;
           to moderate hair loss on a Norwood-Hamilton (N-H) Scale&#xD;
&#xD;
        -  Double-blind: Evaluating Investigator (EI) and participants are blinded; Treating&#xD;
           Investigator (TI) is not blinded&#xD;
&#xD;
        -  Investigational product is randomly assigned to subjects upon enrollment and will&#xD;
           receive either HST 001 or placebo (phosphate buffered saline [PBS]). Injections will be&#xD;
           delivered via 1 mL syringes with 31 Gauge needles to the target depth of 1.75 mm, using&#xD;
           a slow injection technique and holding the needle in position for count of 3-4 seconds.&#xD;
           Each injection will provide 0.1 mL and a total of 20 injections will be given in the&#xD;
           scalp with particular attention to the leading edge of the vertex and the temporal&#xD;
           recession areas&#xD;
&#xD;
        -  Participants will receive intradermal injections at 3 timepoints only: week 0, week 6&#xD;
           and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20&#xD;
           injections spaced approximately 0.8 - 1.2 cm apart from one another. Dosing will be&#xD;
           split between the leading edge of the vertex region (~10 injections covering 10.18 cm2)&#xD;
           and in each temporal recession area (~5 injections covering 7.07cm2) in each.&#xD;
&#xD;
        -  Adverse Events (AEs) will be monitored to ensure safety of participants throughout the&#xD;
           study&#xD;
&#xD;
        -  Efficacy will be assessed at Week 18 and Week 26 via macrophotography and TAHC by the&#xD;
           Canfield HairMetrix System&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Actual">January 20, 2021</completion_date>
  <primary_completion_date type="Actual">November 11, 2020</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant assessment of procedural pain.</measure>
    <time_frame>26 Weeks</time_frame>
    <description>Participant assessment of procedural pain as captured on the &quot;Subject Self Assessment Questionnaire for Pain.&quot; Minimum score is 1, Maximum score is 5, higher score means worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant assessment of pain or other treatment site responses.</measure>
    <time_frame>26 Weeks</time_frame>
    <description>Participant assessment of pain or other treatment site responses as captured on &quot;Subject Self Assessment Questionnaire for Pain.&quot; The number and percent of participants reporting each sensation will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>26 Weeks</time_frame>
    <description>Safety and tolerability of HST 001 by comparing adverse events to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum collection for Anti-Drug Antibodies</measure>
    <time_frame>26 Weeks</time_frame>
    <description>Serum collection for testing for Anti-Drug Antibodies</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute change from baseline total hairs in the target area (TAHC) of the vertex.</measure>
    <time_frame>18 Weeks</time_frame>
    <description>Absolute change from baseline total hairs in the target area (TAHC) of the vertexes measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0 (Baseline).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute change from baseline total TAHC of the right temporal region.</measure>
    <time_frame>18 Weeks</time_frame>
    <description>Absolute change from baseline total TAHC of the right temporal region as measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0 (Baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute change from baseline total TAHC in the vertex and right temporal areas.</measure>
    <time_frame>26 Weeks</time_frame>
    <description>Absolute change from baseline total TAHC in the vertex and right temporal areas as measured by Canfield's HairMetrix macrophotography system at week 26 compared to week 0 (baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area.</measure>
    <time_frame>26 Weeks</time_frame>
    <description>Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area as measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0; and week 26 compared to week 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas.</measure>
    <time_frame>26 Weeks</time_frame>
    <description>Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas derived from Canfield's HairMetrix system measurements at week 18 and week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change from baseline in TAHC, non-vellus hair counts, vellus hair counts at the vertex and right temporal areas.</measure>
    <time_frame>26 Weeks</time_frame>
    <description>Percent change from baseline in TAHC, non-vellus hair counts, vellus hair counts at the vertex and right temporal areas (separately) comparing week 0 to week 18 and week 0 to week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant global assessment of hair growth.</measure>
    <time_frame>26 Weeks</time_frame>
    <description>Participant global assessment of hair growth from global photos on the &quot;Subject Self Assessment Questionnaire for Efficacy,&quot; patient reported outcome measure for hair growth. Minimum score is 7 and Maximum score is 35. Lower scores indicate a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating investigator global assessment of hair growth.</measure>
    <time_frame>26 Weeks</time_frame>
    <description>Evaluating investigator global assessment of hair growth from global photos, captured on the &quot;Global Assessment Likert scale for Hair Growth .&quot; Minimum score is -3 and Maximum score is +3. Positive scores indicate a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Male Pattern Hair Loss</condition>
  <arm_group>
    <arm_group_label>HST 001</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HST 001 (also known as hair stimulating complex [HSC]) is a mixture of growth factors secreted by human dermal fibroblasts when cultured in proprietary bioreactors which are then harvested and concentrated to specific ranges.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - Phosphate Buffered Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Phosphate Buffered Saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HST 001</intervention_name>
    <description>Participants will receive intradermal injections at 3 timepoints only: week 0, week 6 and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20 injections spaced approximately 0.8 - 1.2 cm apart from one another of active treatment (HST 001).</description>
    <arm_group_label>HST 001</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Phosphate Buffered Saline</intervention_name>
    <description>Participants will receive intradermal injections at 3 timepoints only: week 0, week 6 and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20 injections spaced approximately 0.8 - 1.2 cm apart from one another of placebo control (Phosphate Buffered Saline).</description>
    <arm_group_label>Placebo - Phosphate Buffered Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Must be 25 to 55 years of age inclusive, at the time of signing the informed consent&#xD;
&#xD;
          2. Should be in good general health with a healthy scalp with no cutaneous disorder&#xD;
             determined by medical history or physical examination&#xD;
&#xD;
          3. Are classified as III Vertex (3 Vertex), IV (4) and V (5) under the N H Classification&#xD;
             for male pattern hair loss (MPHL). Subjects should have some thinning in both the&#xD;
             vertex and temporal regions of the scalp&#xD;
&#xD;
          4. Willing to maintain the same hair-style during the study period. No razor shaving of&#xD;
             head (bald) prior to study start and throughout the study period&#xD;
&#xD;
          5. Must be Male.&#xD;
&#xD;
          6. Willing to have two dot tattoos of the scalp&#xD;
&#xD;
          7. Willing to have an approximately 1.0 cm2 area of hairs clipped in the vertex region&#xD;
             and 0.5 cm2 in one temporal recession area at each visit where macrophotography is&#xD;
             conducted&#xD;
&#xD;
          8. Willing to comply with scheduled 7 visits in 26 weeks (or screening in + 6 = 7 visits)&#xD;
&#xD;
          9. Willing to continue normal hair care shampoo throughout the course of the study&#xD;
&#xD;
         10. Willing to maintain the same hair care routine and forgo the use of new scalp&#xD;
             products, throughout the study&#xD;
&#xD;
         11. Willing to undergo routine venipuncture for safety laboratory testing as well as a&#xD;
             blood spot test for Vitamin D level analysis&#xD;
&#xD;
         12. Capable of giving informed consent&#xD;
&#xD;
         13. Fluent and literate in English&#xD;
&#xD;
         14. Able to follow instructions and likely to complete all study visits as assessed by&#xD;
             investigator and staff&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. History of keloid formation or significant hyperpigmentation&#xD;
&#xD;
          2. History of other forms of hair loss - Alopecia areata, trichotillomania, scarring&#xD;
             alopecia etc.&#xD;
&#xD;
          3. History of acute or chronic illness that in the opinion of the investigator might&#xD;
             confound the results of the study including some drug medications&#xD;
&#xD;
          4. Active skin diseases (eczema, atopic dermatitis, psoriasis, skin cancer, sun-damaged&#xD;
             skin with actinic keratosis on the scalp, etc.) in or around the area to be treated&#xD;
&#xD;
          5. Routine use of prescription anti inflammatory medications, immunosuppressive drugs, or&#xD;
             antihistamine medications&#xD;
&#xD;
          6. Use of topical drugs or other cosmetics on the scalp&#xD;
&#xD;
          7. Use of over the counter (OTC) or prescriptive topical hair treatments, including hair&#xD;
             transplantation during the last 6 months&#xD;
&#xD;
          8. Currently using a hair system or wig&#xD;
&#xD;
          9. History of hair transplants or scalp reduction surgery&#xD;
&#xD;
         10. History of allergy or intolerance to lidocaine and/or epinephrine&#xD;
&#xD;
         11. Use of hair dye within 3 days of the treatments, otherwise, willing to maintain the&#xD;
             same hair color for the study duration&#xD;
&#xD;
         12. Current enrollment in an investigational drug or device study&#xD;
&#xD;
         13. Has tattoos or scars in scalp that would interfere with visual assessment&#xD;
&#xD;
         14. Is an employee of the investigator's site, and employee or representative of Histogen,&#xD;
             investor, or a relative with one of the above&#xD;
&#xD;
         15. Has a condition or is in a situation which, in the investigator's opinion, may put the&#xD;
             participant at significant risk, may confound the study results, or may interfere&#xD;
             significantly with participant's involvement in the study&#xD;
&#xD;
         16. Known allergy to rice&#xD;
&#xD;
         17. Known allergy to bovine products&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>California Dermatology &amp; Clinical Research Institute</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</mesh_term>
  </condition_browse>
  <!-- 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/NCT04435847
org study id: HST 001-AES-003-HG
nct id: NCT04435847
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
HST 001 (also known as hair stimulating complex [HSC]) is a mixture of growth factors
      secreted by human dermal fibroblasts when cultured in proprietary bioreactors which are then
      harvested and concentrated to specific ranges. In both preclinical studies and in previous
      clinical trials, HSC has been shown to be safe, with no serious adverse events reported. This
      protocol design is based on the completed Phase 1 study in women which used a similar
      investigational product (Study 16-HIS002-US; HSC660), and includes specific objective
      efficacy endpoints (macrophotography) to measure Target Area Hair Counts (TAHC) after three
      separate doses of product separated by six weeks (week 0, week 6, week 12) and comparing to
      placebo treated group
-  Single center, randomized, controlled, parallel-design study in participants with mild
           to moderate hair loss on a Norwood-Hamilton (N-H) Scale

        -  Double-blind: Evaluating Investigator (EI) and participants are blinded; Treating
           Investigator (TI) is not blinded

        -  Investigational product is randomly assigned to subjects upon enrollment and will
           receive either HST 001 or placebo (phosphate buffered saline [PBS]). Injections will be
           delivered via 1 mL syringes with 31 Gauge needles to the target depth of 1.75 mm, using
           a slow injection technique and holding the needle in position for count of 3-4 seconds.
           Each injection will provide 0.1 mL and a total of 20 injections will be given in the
           scalp with particular attention to the leading edge of the vertex and the temporal
           recession areas

        -  Participants will receive intradermal injections at 3 timepoints only: week 0, week 6
           and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20
           injections spaced approximately 0.8 - 1.2 cm apart from one another. Dosing will be
           split between the leading edge of the vertex region (~10 injections covering 10.18 cm2)
           and in each temporal recession area (~5 injections covering 7.07cm2) in each.

        -  Adverse Events (AEs) will be monitored to ensure safety of participants throughout the
           study

        -  Efficacy will be assessed at Week 18 and Week 26 via macrophotography and TAHC by the
           Canfield HairMetrix System
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Participant assessment of procedural pain.
time frame: 26 Weeks
description: Participant assessment of procedural pain as captured on the "Subject Self Assessment Questionnaire for Pain." Minimum score is 1, Maximum score is 5, higher score means worse outcome.
measure: Participant assessment of pain or other treatment site responses.
time frame: 26 Weeks
description: Participant assessment of pain or other treatment site responses as captured on "Subject Self Assessment Questionnaire for Pain." The number and percent of participants reporting each sensation will be collected.
measure: Adverse Events
time frame: 26 Weeks
description: Safety and tolerability of HST 001 by comparing adverse events to baseline
measure: Serum collection for Anti-Drug Antibodies
time frame: 26 Weeks
description: Serum collection for testing for Anti-Drug Antibodies
measure: Absolute change from baseline total hairs in the target area (TAHC) of the vertex.
time frame: 18 Weeks
description: Absolute change from baseline total hairs in the target area (TAHC) of the vertexes measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0 (Baseline).
measure: Absolute change from baseline total TAHC of the right temporal region.
time frame: 18 Weeks
description: Absolute change from baseline total TAHC of the right temporal region as measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0 (Baseline).
measure: Absolute change from baseline total TAHC in the vertex and right temporal areas.
time frame: 26 Weeks
description: Absolute change from baseline total TAHC in the vertex and right temporal areas as measured by Canfield's HairMetrix macrophotography system at week 26 compared to week 0 (baseline).
measure: Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area.
time frame: 26 Weeks
description: Absolute change from baseline in non-vellus and vellus hair count in the vertex and right temporal area as measured by Canfield's HairMetrix macrophotography system at week 18 compared to week 0; and week 26 compared to week 0.
measure: Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas.
time frame: 26 Weeks
description: Cumulative thickness density (total hair count x total hair width) in the vertex and temporal areas derived from Canfield's HairMetrix system measurements at week 18 and week 26.
measure: Percent change from baseline in TAHC, non-vellus hair counts, vellus hair counts at the vertex and right temporal areas.
time frame: 26 Weeks
description: Percent change from baseline in TAHC, non-vellus hair counts, vellus hair counts at the vertex and right temporal areas (separately) comparing week 0 to week 18 and week 0 to week 26.
measure: Participant global assessment of hair growth.
time frame: 26 Weeks
description: Participant global assessment of hair growth from global photos on the "Subject Self Assessment Questionnaire for Efficacy," patient reported outcome measure for hair growth. Minimum score is 7 and Maximum score is 35. Lower scores indicate a better outcome.
measure: Evaluating investigator global assessment of hair growth.
time frame: 26 Weeks
description: Evaluating investigator global assessment of hair growth from global photos, captured on the "Global Assessment Likert scale for Hair Growth ." Minimum score is -3 and Maximum score is +3. Positive scores indicate a better outcome.
arm group label: HST 001
arm group type: Experimental
description: HST 001 (also known as hair stimulating complex [HSC]) is a mixture of growth factors secreted by human dermal fibroblasts when cultured in proprietary bioreactors which are then harvested and concentrated to specific ranges.
arm group label: Placebo - Phosphate Buffered Saline
arm group type: Placebo Comparator
description: Phosphate Buffered Saline
intervention type: Biological
intervention name: HST 001
description: Participants will receive intradermal injections at 3 timepoints only: week 0, week 6 and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20 injections spaced approximately 0.8 - 1.2 cm apart from one another of active treatment (HST 001).
arm group label: HST 001
intervention type: Other
intervention name: Phosphate Buffered Saline
description: Participants will receive intradermal injections at 3 timepoints only: week 0, week 6 and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20 injections spaced approximately 0.8 - 1.2 cm apart from one another of placebo control (Phosphate Buffered Saline).
arm group label: Placebo - Phosphate Buffered Saline
criteria: 
gender: Male
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alopecia
mesh term: Alopecia Areata