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/NCT05970809</url>
    </required_header>
    <id_info>
      <org_study_id>CS-SAGA-001</org_study_id>
      <nct_id>NCT05970809</nct_id>
    </id_info>
    <brief_title>Assessing the Safety and Efficacy of a Novel Microneedling and Laser Device for Male Pattern Hair Loss</brief_title>
    <acronym>CS-SAGA-001</acronym>
    <official_title>A Randomised, Evaluator-Blinded, Two-Arm Study To Evaluate The Safety And Efficacy of a Novel Microneedle and Laser-Based Medical Device For The Treatment of Androgenetic Alopecia in Adult Males</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>StimuSIL</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ankara City Hospital Bilkent</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>StimuSIL</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this 24-week study is to see if the SAGA-001 device is safe and effective at&#xD;
        helping people with male pattern hair loss.&#xD;
  &#xD;
        Two different device configurations are being explored as part of this study. Device A has&#xD;
        novel microneedles, lasers, and additional metal microneedles, while Device B only has novel&#xD;
        microneedles and lasers.&#xD;
  &#xD;
        Participants will receive 12 treatments with either Device A or Device B over the course of&#xD;
        24 weeks. Treatments will be performed on-site every two weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will have the medical tests or procedures described below:&#xD;
  &#xD;
          -  Subjects will be asked about their previous medical history and current medications.&#xD;
  &#xD;
          -  Brief physical examinations will be performed, including a visual inspection of the&#xD;
             scalp.&#xD;
  &#xD;
          -  Questions about medical history (including previous and current medication use) will be&#xD;
             asked.&#xD;
  &#xD;
          -  Two types of photos will be taken: 1) &quot;global photos&quot;, which are general photos of the&#xD;
             subject's scalp, and 2) &quot;macro photos&quot;, which are close-up photos of a part of the&#xD;
             subject's scalp.&#xD;
  &#xD;
          -  Questions about treatment-related issues or unpleasantness will be asked.&#xD;
  &#xD;
          -  Subjects will be asked to rate the improvement they see in their photos.&#xD;
  &#xD;
          -  Subjects will be asked to rate their satisfaction with the treatment.&#xD;
  &#xD;
        Participants will also be asked to record changes in medications, changes in medical&#xD;
        treatments, and major life changes (such as major dietary changes, exercise changes, changes&#xD;
        in life stressors, etc.) in a diary for the duration of treatment. They should also make note&#xD;
        of any suspected side effects or issues they believe are related to the treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <phase>N/A</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>Double (Participant, Investigator)</masking>
      <masking_description>Participants will be randomly allocated at a 1:1 ratio to receive treatment with Device type A or B.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in terminal hair density</measure>
      <time_frame>24 weeks</time_frame>
      <description>Changes in terminal hair density at the 24-week time point compared to baseline will be investigated using a binomial test for one proportion at a one-sided alpha with a 95% exact confidence interval, considering pi ≥ 60%, where pi is the true percentage of responders in the study population.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in terminal hair density</measure>
      <time_frame>16 weeks</time_frame>
      <description>Changes in terminal hair density at the 16-week time point compared to baseline will be investigated using a binomial test for one proportion at a one-sided alpha with a 95% exact confidence interval, considering pi ≥ 60%, where pi is the true percentage of responders in the study population.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in hair thickness</measure>
      <time_frame>16 weeks</time_frame>
      <description>Increases and/or decreases in hair diameter at the 16-week time point compared to baseline will be investigated using a paired t-test at a one-sided alpha and a 95% confidence interval for mean change.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in hair thickness</measure>
      <time_frame>24 weeks</time_frame>
      <description>Increases and/or decreases in hair diameter at the 24-week time point compared to baseline will be investigated using a paired t-test at a one-sided alpha and a 95% confidence interval for mean change.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Male Pattern Baldness</condition>
    <condition>Androgenetic Alopecia</condition>
    <condition>Hair Loss/Baldness</condition>
    <condition>Hair Loss</condition>
    <condition>Pattern Baldness</condition>
    <arm_group>
      <arm_group_label>Device A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Device configuration A has metal and novel microneedles and lasers.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Device B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Device configuration B has novel microneedles and lasers.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SAGA-001 (A)</intervention_name>
      <description>Use of a novel microneedle and laser device as a treatment for male patten hair loss with additional microwounding.</description>
      <arm_group_label>Device A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SAGA-001 (B)</intervention_name>
      <description>Use of a novel microneedle and laser device as a treatment for male patten hair loss without additional microwounding.</description>
      <arm_group_label>Device B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject is willing to sign an informed consent form&#xD;
  &#xD;
            -  Subject is within the age group of 22-55 years (including both ages)&#xD;
  &#xD;
            -  Subject is male&#xD;
  &#xD;
            -  Subject has AGA with a Stage IIa-V Hamilton-Norwood classification&#xD;
  &#xD;
            -  Subject's skin is within Fitzpatrick Skin Types I-IV&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects who have used any formulation or application/administration or type of&#xD;
               treatment for disorders of the skin or scalp within 180 days prior to screening,&#xD;
               including but not limited to the following treatments:&#xD;
  &#xD;
                 1. Anti-inflammatory medications, including topical steroids&#xD;
  &#xD;
                 2. Antifungal&#xD;
  &#xD;
                 3. Skin, nail, hair rejuvenation supplementation, or IV infusions (includes vitamin,&#xD;
                    minerals, herbals, etc.)&#xD;
  &#xD;
                 4. Hair growth shampoos, conditioners, and topicals&#xD;
  &#xD;
                 5. Topical, dermal or oral minoxidil, finasteride, or dutasteride&#xD;
  &#xD;
                 6. Hair growth stimulation treatments, i.e. PRP, stem cells, exosomes, growth&#xD;
                    factors, microneedling, mesotherapy&#xD;
  &#xD;
                 7. LED or low level laser therapy treatments, ie. laser helmets, laser caps, and&#xD;
                    laser combs&#xD;
  &#xD;
                 8. Infrared saunas&#xD;
  &#xD;
            -  Subjects with alopecia other than AGA, such as alopecia areata, alopecia totalis,&#xD;
               telogen effluvium, anagen effluvium, and acquired cicatricial alopecia&#xD;
  &#xD;
            -  Subjects with a history of bleeding disorders&#xD;
  &#xD;
            -  Subjects on anticoagulant medications (aspirin, warfarin, heparin)&#xD;
  &#xD;
            -  Subject on autoimmune suppressant medications or suffering autoimmune diseases (e.g.&#xD;
               humira)&#xD;
  &#xD;
            -  Subjects with an active infection at the local site&#xD;
  &#xD;
            -  Subjects with keloidal tendencies&#xD;
  &#xD;
            -  Subjects with chronic dermatological conditions affecting the scalp (e.g. eczema,&#xD;
               psoriasis, etc.)&#xD;
  &#xD;
            -  Subjects with hepatic or renal disease, epilepsy, or any other major medical illness*&#xD;
  &#xD;
            -  Subjects that have undergone evaluation to rule out other causes of hair loss, because&#xD;
               underlying causes (e.g., iron deficiency, lupus, thyroid disease, telogen effluvium,&#xD;
               post-pregnancy, polycystic ovary, chemotherapy, etc.) would preclude assessment of&#xD;
               performance in an androgenetic alopecia trial&#xD;
  &#xD;
            -  Subjects who are photosensitive or are using photosensitive drugs or topicals.&#xD;
  &#xD;
            -  Subjects who are taking anxiolytics medications&#xD;
  &#xD;
            -  Subjects who have been on hormone inhibitors or on hormone replacement therapy in the&#xD;
               last 180 days&#xD;
  &#xD;
            -  Subjects who are at high risk of seizures&#xD;
  &#xD;
            -  Subjects who have a malignancy or a history of malignancies affecting the scalp&#xD;
  &#xD;
            -  Subjects that have undergone hair transplantation, scalp reduction, radiation to the&#xD;
               scalp or chemotherapy within their lifetime.&#xD;
  &#xD;
            -  Subjects with current hair weaves, hair extensions, scalp tattoos, or who use&#xD;
               occlusive wigs.&#xD;
  &#xD;
            -  Subjects who have used semi-permanent hair products (e.g. color, texturizers or&#xD;
               relaxers) within 30 days prior to screening.&#xD;
  &#xD;
            -  Subjects with hair shorter than one-half inch (approximately 1.2 cm).&#xD;
  &#xD;
            -  Subjects who are unable to make regular follow-up visits.&#xD;
  &#xD;
            -  Subjects who are immediate family members (spouse, parent, child, or sibling;&#xD;
               biological or legally adopted) of personnel directly affiliated with the study at the&#xD;
               investigative sites, or individuals who are directly affiliated with the study at the&#xD;
               investigative sites, or individuals directly affiliated with the study sponsor.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Server Serdaroğlu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ana I Villalba</last_name>
      <phone>+34 647160346</phone>
      <email>ana@stimusil.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Siddhi BC Lama, PhD</last_name>
      <email>siddhi@stimusil.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ankara Bilkent Şehir Hastanesi Dermatoloji Klini</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Akın Aktaş, MD</last_name>
        <email>aaktas@ybu.edu.tr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü Deri ve Zührevi Hastalıklar Ana Bilim Dalı Kocamustafa Paşa</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Server Serdaroğlu, MD</last_name>
        <email>server.serdaroglu@iuc.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <link>
      <url>https://stimusil.com/</url>
      <description>StimuSIL's website</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>lasers</keyword>
    <keyword>laser therapy</keyword>
    <keyword>low-level light therapy</keyword>
    <keyword>Low-Power Laser Therapy</keyword>
    <keyword>Photobiomodulation Therapy</keyword>
    <keyword>Low-Level Laser Therapy</keyword>
    <keyword>Laser Biostimulation</keyword>
    <keyword>LLLT</keyword>
    <keyword>microtrauma, physical</keyword>
    <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>
  
  
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/NCT05970809
  org study id: CS-SAGA-001
  nct id: NCT05970809
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this 24-week study is to see if the SAGA-001 device is safe and effective at
        helping people with male pattern hair loss.
  
        Two different device configurations are being explored as part of this study. Device A has
        novel microneedles, lasers, and additional metal microneedles, while Device B only has novel
        microneedles and lasers.
  
        Participants will receive 12 treatments with either Device A or Device B over the course of
        24 weeks. Treatments will be performed on-site every two weeks.
  Participants will have the medical tests or procedures described below:
  
          -  Subjects will be asked about their previous medical history and current medications.
  
          -  Brief physical examinations will be performed, including a visual inspection of the
             scalp.
  
          -  Questions about medical history (including previous and current medication use) will be
             asked.
  
          -  Two types of photos will be taken: 1) "global photos", which are general photos of the
             subject's scalp, and 2) "macro photos", which are close-up photos of a part of the
             subject's scalp.
  
          -  Questions about treatment-related issues or unpleasantness will be asked.
  
          -  Subjects will be asked to rate the improvement they see in their photos.
  
          -  Subjects will be asked to rate their satisfaction with the treatment.
  
        Participants will also be asked to record changes in medications, changes in medical
        treatments, and major life changes (such as major dietary changes, exercise changes, changes
        in life stressors, etc.) in a diary for the duration of treatment. They should also make note
        of any suspected side effects or issues they believe are related to the treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: Participants will be randomly allocated at a 1:1 ratio to receive treatment with Device type A or B.
  measure: Change in terminal hair density
  time frame: 24 weeks
  description: Changes in terminal hair density at the 24-week time point compared to baseline will be investigated using a binomial test for one proportion at a one-sided alpha with a 95% exact confidence interval, considering pi ≥ 60%, where pi is the true percentage of responders in the study population.
  measure: Change in terminal hair density
  time frame: 16 weeks
  description: Changes in terminal hair density at the 16-week time point compared to baseline will be investigated using a binomial test for one proportion at a one-sided alpha with a 95% exact confidence interval, considering pi ≥ 60%, where pi is the true percentage of responders in the study population.
  measure: Change in hair thickness
  time frame: 16 weeks
  description: Increases and/or decreases in hair diameter at the 16-week time point compared to baseline will be investigated using a paired t-test at a one-sided alpha and a 95% confidence interval for mean change.
  measure: Change in hair thickness
  time frame: 24 weeks
  description: Increases and/or decreases in hair diameter at the 24-week time point compared to baseline will be investigated using a paired t-test at a one-sided alpha and a 95% confidence interval for mean change.
  arm group label: Device A
  arm group type: Experimental
  description: Device configuration A has metal and novel microneedles and lasers.
  arm group label: Device B
  arm group type: Experimental
  description: Device configuration B has novel microneedles and lasers.
  intervention type: Device
  intervention name: SAGA-001 (A)
  description: Use of a novel microneedle and laser device as a treatment for male patten hair loss with additional microwounding.
  arm group label: Device A
  intervention type: Device
  intervention name: SAGA-001 (B)
  description: Use of a novel microneedle and laser device as a treatment for male patten hair loss without additional microwounding.
  arm group label: Device B
  criteria: 
  gender: Male
  minimum age: 22 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: Server Serdaroğlu, MD
  role: Principal Investigator
  affiliation: İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi
  last name: Ana I Villalba
  phone: +34 647160346
  email: ana@stimusil.com
  last name: Siddhi BC Lama, PhD
  email: siddhi@stimusil.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  url: https://stimusil.com/
  description: StimuSIL's website
  responsible party type: Sponsor
  mesh term: Alopecia
  mesh term: Alopecia Areata