<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/NCT01686295</url>
  </required_header>
  <id_info>
    <org_study_id>CS940112</org_study_id>
    <secondary_id>CS940112</secondary_id>
    <nct_id>NCT01686295</nct_id>
  </id_info>
  <brief_title>24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness</brief_title>
  <official_title>A Randomized, Double -Blind,, Sham-Device-Controlled, Multicenter, 24-Week Clinical Trial to Evaluate the Safety and Effectiveness of the iRestore ™ Hair Rejuvenation System in the Treatment of Male and Female Androgeneticalopecia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Freedom Laser Therapy, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TKL Research, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Freedom Laser Therapy, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of the iRestore Hair Rejuvenation&#xD;
      System when used as directed in promoting hair growth in men and women with androgenetic&#xD;
      alopecia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The test treatment is the iRestore™ Hair Rejuvenation System. The device irradiates the scalp&#xD;
      with visible light using 5 mW (class 3a) lasers. It is to be used approximately 3 times per&#xD;
      week for approximately 30 minutes at each session.&#xD;
&#xD;
      The System is placed on the head and adjusted to a comfortable size by rotating knobs on the&#xD;
      side of the device. If needed, subjects may replace the soft pad on the inside of the device&#xD;
      with the thinner pad provided. There will be 2 options for using the product. The subject&#xD;
      will either insert the 5-V AC power adapter pin into the device remote control, and the 5-V&#xD;
      adapter will then be plugged into the AC outlet; or the subjects will use the rechargeable&#xD;
      battery pack and belt clip. The battery pack is an external device which will allow the&#xD;
      subject the freedom of mobility while treating the hair. The rechargeable battery pack will&#xD;
      hold a charge for up to 3 hours prior to needing to be recharged. The iRestore™ remote&#xD;
      control clips into the battery holster and the pack plugs into the remote. The battery pack&#xD;
      can be placed in a pocket, clipped to the belt or placed next to the subject. The device will&#xD;
      be turned on by pressing the power button on the remote control. The dome of the device is to&#xD;
      be moved forward and backward by the subject to brush through the hair and increase the&#xD;
      direct light which comes into contact with the scalp. Subjects will then position the dome at&#xD;
      the front of the scalp and press the start button to begin a 10-minute session. Note: As a&#xD;
      safety feature, the dome must be placed onto the head prior to starting the device. A timer&#xD;
      will indicate the completion of the session with a beep sound. Subjects will complete the&#xD;
      same process as done with the front of the scalp with the dome repositioned to the middle of&#xD;
      the scalp and then the back of the scalp. Once all 3 positions have received the 10 minute&#xD;
      treatment, the power button is to be held for approximately 3 seconds to turn the device off.&#xD;
      Once off the device is to be unplugged from the wall.&#xD;
&#xD;
      The control device will be identical to the test device except that the laser-emitting units&#xD;
      will be disabled. A standard light will be emitted from the device. Subjects and clinical&#xD;
      staff engaged in the performance of assessments will be treatment blinded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">April 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Screening/Baseline Hair Growth at Week 12 and Week 24</measure>
    <time_frame>Screening/Baseline, Week 12, and Week 24. The hair will be clean and properly combed for each individual in the following manner</time_frame>
    <description>Standardized global scalp photographs will be taken of each subject prior to hair clipping for hair count macrophotography. These photographs will be obtained at Screening/Baseline, Week 12, and Week 24.To determine any differences from baseline photos.&#xD;
Frontal (male only) and Top Scalp Views (female only): Hair will be center-parted and combed away from the part.&#xD;
Vertex View (male only): Hair will be combed away from the center of the vertex like the spokes of a wheel.&#xD;
Global scalp photographs will be sent to Canfield Scientific, Inc. a central core lab for study imaging.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Scalp Assessment</measure>
    <time_frame>At Baseline, Week 4, Week 12, and Week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee</time_frame>
    <description>At Baseline, Week 4, Week 12, and Week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee for any sign of irritation or dermatologic conditions (eg, erythema, edema, dryness, scaling). The grading scale provided in Table 5 will be used to categorize each condition:&#xD;
Table 5: Visual Scalp Assessment Scale SCORE RESPONSE 0 None&#xD;
Mild&#xD;
Moderate&#xD;
Severe</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Androgenetic Alopecia</condition>
  <arm_group>
    <arm_group_label>iRestore Hair Rejuvenation System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Seventy six (76) subjects will be enrolled in the 24-week study; of which 38 will be male and 38 will be female using the iRestore hair growth device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Device Arm</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This study arm will use a sham device consistent with the experimental device with 12 men and 12 women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iRestore Hair Rejuvenation System</intervention_name>
    <description>This study is to evaluate the effectiveness of the iRestore Hair Rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days</description>
    <arm_group_label>iRestore Hair Rejuvenation System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham device</intervention_name>
    <description>This shame device will be a sham comparator to evaluate the effectiveness of the iRestore Hair rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days</description>
    <arm_group_label>Sham Device Arm</arm_group_label>
    <other_name>iRestore Hair Rejovenation System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals eligible for inclusion in the study are those who:&#xD;
&#xD;
               1. Are male or female, 25 to 60 years of age;&#xD;
&#xD;
               2. If male, have Norwood-Hamilton classifications of IIa to V male pattern baldness;&#xD;
&#xD;
               3. If female, have Ludwig Scale classifications I-4, II-1, II-2, or frontal;&#xD;
&#xD;
               4. Are willing to have a tattoo created on the target area;&#xD;
&#xD;
               5. Have been experiencing active hair loss within the last 12 months;&#xD;
&#xD;
               6. In the case of females of childbearing potential, are using an acceptable form of&#xD;
                  birth control (oral/implant/injectable/transdermal contraceptives, intrauterine&#xD;
                  device, condom with spermicide, diaphragm with spermicide, abstinence or&#xD;
                  partner's vasectomy: abstinence or partner's vasectomy are acceptable if the&#xD;
                  female agrees to implement one of the other acceptable methods of birth control&#xD;
                  if her lifestyle or partner changes);&#xD;
&#xD;
               7. Have Fitzpatrick Skin Type I-IV (See Table 1 Below);&#xD;
&#xD;
               8. Are willing to have the target area hair clipped;&#xD;
&#xD;
               9. Read, understand, and sign a photographic release form(s); and&#xD;
&#xD;
              10. Read, understand, and sign an informed consent document after being advised of&#xD;
                  the nature of the study.&#xD;
&#xD;
        Table 1: Fitzpatrick Skin Types I Always burns easily, never tans II Always burns easily,&#xD;
        tans minimally III Burns moderately, tans gradually (light brown) IV Burns minimally,&#xD;
        always tans well (moderate brown) V Rarely burns, tans very well (moderate brown) VI Never&#xD;
        burn, deeply pigmented&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals excluded from participation in the study are those who:&#xD;
&#xD;
               1. Have used any of the following medications within 6 months prior to enrollment:&#xD;
&#xD;
                    -  minoxidil, finasteride (or any other 5α-reductase inhibitor medications);&#xD;
&#xD;
                    -  medications with anti-androgenic properties (eg, cyproterone,&#xD;
                       spironolactone, ketoconazole, flutamide, and bicalutamide);&#xD;
&#xD;
                    -  topical estrogens, progesterone, tamoxifen, anabolic steroids;&#xD;
&#xD;
                    -  medications that can potentially cause hypertrichosis (eg, ciclosporin,&#xD;
                       diazoxide, phenytoin, and psoralens);&#xD;
&#xD;
                    -  oral glucocorticoids (inhaled glucocorticoids are permitted);&#xD;
&#xD;
                    -  lithium or phenothiazines;&#xD;
&#xD;
                    -  medications of known or suspected phototoxicity (eg, tetracyclines,&#xD;
                       thiazides, certain NSAIDs);&#xD;
&#xD;
                    -  other medications which, in the opinion of the investigator, may interfere&#xD;
                       with the performance of study assessments or place the subject at undue&#xD;
                       risk;&#xD;
&#xD;
               2. Will not agree to refrain from changing hair color and hair style during the&#xD;
                  course of the study;&#xD;
&#xD;
               3. Have had a hair transplant, scalp reduction, hair weave, or tattoo which, in the&#xD;
                  opinion of the investigator, may interfere with the performance of the study&#xD;
                  assessments;&#xD;
&#xD;
               4. Are using or have used depilatories, razors, or wax on the scalp to an extent&#xD;
                  which, in the opinion of the investigator, may interfere with the performance of&#xD;
                  the study assessments;&#xD;
&#xD;
               5. Have psoriasis, active dermatitis/eczema, or severe acne on the scalp area;&#xD;
&#xD;
               6. Have diabetes requiring exogenous insulin;&#xD;
&#xD;
               7. Have cataracts;&#xD;
&#xD;
               8. Have any medical condition which, in the opinion of the investigator, could&#xD;
                  affect hair growth (eg, Human Immunodeficiency Virus, connective tissue disease,&#xD;
                  inflammatory bowel disease);&#xD;
&#xD;
               9. Have very little contrast between hair color and scalp, eg, are of a fair hair&#xD;
                  color (eg, white or very blond) and have very pale skin;&#xD;
&#xD;
              10. Are females who are pregnant, planning to become pregnant during the study, or&#xD;
                  breastfeeding; and/or&#xD;
&#xD;
              11. Are, in the opinion of the investigative personnel, unable to comprehend and/or&#xD;
                  otherwise comply with any aspect of study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Dosik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TKL Research, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TKL Research Inc.</name>
      <address>
        <city>Paramus</city>
        <state>New Jersey</state>
        <zip>07652</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>C Andresen</last_name>
      <phone>201-587-0808</phone>
      <email>candresen@tklresearch.com</email>
    </contact>
    <investigator>
      <last_name>Jonathan Dosik, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>September 12, 2012</last_update_submitted>
  <last_update_submitted_qc>September 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>androgenetic alopecia</keyword>
  <keyword>Baldness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</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/NCT01686295
org study id: CS940112
secondary id: CS940112
nct id: NCT01686295
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the effectiveness of the iRestore Hair Rejuvenation
      System when used as directed in promoting hair growth in men and women with androgenetic
      alopecia
The test treatment is the iRestore™ Hair Rejuvenation System. The device irradiates the scalp
      with visible light using 5 mW (class 3a) lasers. It is to be used approximately 3 times per
      week for approximately 30 minutes at each session.

      The System is placed on the head and adjusted to a comfortable size by rotating knobs on the
      side of the device. If needed, subjects may replace the soft pad on the inside of the device
      with the thinner pad provided. There will be 2 options for using the product. The subject
      will either insert the 5-V AC power adapter pin into the device remote control, and the 5-V
      adapter will then be plugged into the AC outlet; or the subjects will use the rechargeable
      battery pack and belt clip. The battery pack is an external device which will allow the
      subject the freedom of mobility while treating the hair. The rechargeable battery pack will
      hold a charge for up to 3 hours prior to needing to be recharged. The iRestore™ remote
      control clips into the battery holster and the pack plugs into the remote. The battery pack
      can be placed in a pocket, clipped to the belt or placed next to the subject. The device will
      be turned on by pressing the power button on the remote control. The dome of the device is to
      be moved forward and backward by the subject to brush through the hair and increase the
      direct light which comes into contact with the scalp. Subjects will then position the dome at
      the front of the scalp and press the start button to begin a 10-minute session. Note: As a
      safety feature, the dome must be placed onto the head prior to starting the device. A timer
      will indicate the completion of the session with a beep sound. Subjects will complete the
      same process as done with the front of the scalp with the dome repositioned to the middle of
      the scalp and then the back of the scalp. Once all 3 positions have received the 10 minute
      treatment, the power button is to be held for approximately 3 seconds to turn the device off.
      Once off the device is to be unplugged from the wall.

      The control device will be identical to the test device except that the laser-emitting units
      will be disabled. A standard light will be emitted from the device. Subjects and clinical
      staff engaged in the performance of assessments will be treatment blinded.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from Screening/Baseline Hair Growth at Week 12 and Week 24
time frame: Screening/Baseline, Week 12, and Week 24. The hair will be clean and properly combed for each individual in the following manner
description: Standardized global scalp photographs will be taken of each subject prior to hair clipping for hair count macrophotography. These photographs will be obtained at Screening/Baseline, Week 12, and Week 24.To determine any differences from baseline photos.
Frontal (male only) and Top Scalp Views (female only): Hair will be center-parted and combed away from the part.
Vertex View (male only): Hair will be combed away from the center of the vertex like the spokes of a wheel.
Global scalp photographs will be sent to Canfield Scientific, Inc. a central core lab for study imaging.
measure: Visual Scalp Assessment
time frame: At Baseline, Week 4, Week 12, and Week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee
description: At Baseline, Week 4, Week 12, and Week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee for any sign of irritation or dermatologic conditions (eg, erythema, edema, dryness, scaling). The grading scale provided in Table 5 will be used to categorize each condition:
Table 5: Visual Scalp Assessment Scale SCORE RESPONSE 0 None
Mild
Moderate
Severe
arm group label: iRestore Hair Rejuvenation System
arm group type: Experimental
description: Seventy six (76) subjects will be enrolled in the 24-week study; of which 38 will be male and 38 will be female using the iRestore hair growth device
arm group label: Sham Device Arm
arm group type: Sham Comparator
description: This study arm will use a sham device consistent with the experimental device with 12 men and 12 women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days
intervention type: Device
intervention name: iRestore Hair Rejuvenation System
description: This study is to evaluate the effectiveness of the iRestore Hair Rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days
arm group label: iRestore Hair Rejuvenation System
intervention type: Device
intervention name: sham device
description: This shame device will be a sham comparator to evaluate the effectiveness of the iRestore Hair rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days
arm group label: Sham Device Arm
other name: iRestore Hair Rejovenation System
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan Dosik, MD
role: Principal Investigator
affiliation: TKL Research, Inc.
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Alopecia