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/NCT06029725</url>
    </required_header>
    <id_info>
      <org_study_id>03-23</org_study_id>
      <nct_id>NCT06029725</nct_id>
    </id_info>
    <brief_title>RFMN in Combination With 1927 nm Thulium Laser for Treating Photoaged Skin</brief_title>
    <official_title>RFMN in Combination With 1927 nm Thulium Laser for Treating Photoaged Skin: a Prospective, Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitätsklinikum Hamburg-Eppendorf</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 appearance of the aging skin is influenced by different factors including by the reduced&#xD;
        elasticity and increased laxity of the skin, the decreasing volume as well as pigmentation&#xD;
        disorders and dilated vascular markings. Currently, there are different methods available to&#xD;
        treat the aging skin. Here, the combined treatment of radiofrequency micro needling (RFMN)&#xD;
        and thulium laser has been commonly used in clinical practice.&#xD;
  &#xD;
        The aim of this clinical study is to investigate the efficacy, patient satisfaction, safety&#xD;
        of RFMN and thulium laser treatment in patients with facial, age-related skin laxity,&#xD;
        wrinkles, and pigmented lesions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 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>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in wrinkles</measure>
      <time_frame>6 months after last treatment session</time_frame>
      <description>software-assisted evaluation of wrinkles (Vectra(R) Software, Canfield)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in volume</measure>
      <time_frame>6 months after last treatment session</time_frame>
      <description>software-assisted evaluation of volume (Vectra(R) Software, Canfield)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in pigmentation</measure>
      <time_frame>6 months after last treatment session</time_frame>
      <description>software-assisted evaluation of pigmentation (Vectra(R) Software, Canfield)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain intensity</measure>
      <time_frame>10 minutes after starting each treatment session, one treatment session takes 30-50 minutes</time_frame>
      <description>pain intensity (numeric rating scale) during treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events</measure>
      <time_frame>before every treatment session, at every follow-up visit (3 and 6 months post-treatment)</time_frame>
      <description>number of adverse events (AE)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Withdrawals due to AE</measure>
      <time_frame>before every treatment session, at every follow-up visit (3 and 6 months post-treatment)</time_frame>
      <description>number of withdrawal due to AE</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Photoaging</condition>
    <arm_group>
      <arm_group_label>RFMN+Thulium</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>RFMN</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>radiofrequency microneedling combined with 1927 nm thulium laser</intervention_name>
      <description>session: radiofrequency microneedling + 1927 nm thulium laser&#xD;
  session: 1927 nm thulium laser monotherapy&#xD;
  session: 1927 nm thulium laser monotherapy</description>
      <arm_group_label>RFMN+Thulium</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>radiofrequency microneedling monotherapy</intervention_name>
      <description>1 session: radiofrequency microneedling monotherapy</description>
      <arm_group_label>RFMN</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men and women from the age of 30 years&#xD;
  &#xD;
            -  good general condition, no relevant previous diseases&#xD;
  &#xD;
            -  Presence of wrinkles, dermatochalasis on the face, pigment spots, which are an&#xD;
               indication for RFMN and thulium laser or comparable methods&#xD;
  &#xD;
            -  Cognitive ability and willingness to give consent (informed consent)&#xD;
  &#xD;
            -  Be willing and able to attend follow-up visits&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt; 30 years&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Excessive subcutaneous fatty tissue under the cheeks&#xD;
  &#xD;
            -  Significant scarring of the region to be treated&#xD;
  &#xD;
            -  open wounds or lesions of the region to be treated&#xD;
  &#xD;
            -  Severe or cystic facial acne&#xD;
  &#xD;
            -  Metallic implants in the face or neck region&#xD;
  &#xD;
            -  Mental illnesses (psychoses, body perception disorders)&#xD;
  &#xD;
            -  Use of isotretinoin or other retinoids, psychotropic drugs, coumarins or heparins in&#xD;
               the last 2 weeks&#xD;
  &#xD;
            -  Fillers in the region to be treated &lt; 4 weeks prior and during the study period&#xD;
  &#xD;
            -  Resurfacing (fractional, ablative, nonablative) of the region of interest &lt; 2 months&#xD;
               prior and during the study period&#xD;
  &#xD;
            -  Plastic aesthetic procedures or other surgical procedures &lt; 6 months prior and during&#xD;
               the study period&#xD;
  &#xD;
            -  Tendency to have excessive scarring&#xD;
  &#xD;
            -  Lack of informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>L Nguyen</last_name>
      <phone>+49</phone>
      <email>l.nguyen@uke.de</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Medical Center Hamburg-Eppendorf</name>
        <address>
          <city>Hamburg</city>
          <zip>20251</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>L Nguyen</last_name>
        <phone>+49 (0)40-74100</phone>
        <email>l.nguyen@uke.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <reference>
      <citation>Berneburg M, Plettenberg H, Krutmann J. Photoaging of human skin. Photodermatol Photoimmunol Photomed. 2000 Dec;16(6):239-44. doi: 10.1034/j.1600-0781.2000.160601.x.</citation>
      <PMID>11132125</PMID>
    </reference>
    <reference>
      <citation>el-Domyati M, el-Ammawi TS, Medhat W, Moawad O, Brennan D, Mahoney MG, Uitto J. Radiofrequency facial rejuvenation: evidence-based effect. J Am Acad Dermatol. 2011 Mar;64(3):524-35. doi: 10.1016/j.jaad.2010.06.045.</citation>
      <PMID>21315951</PMID>
    </reference>
    <reference>
      <citation>Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study. Arch Dermatol. 2004 Feb;140(2):204-9. doi: 10.1001/archderm.140.2.204.</citation>
      <PMID>14967794</PMID>
    </reference>
    <reference>
      <citation>Nguyen L, Blessmann M, Schneider SW, Herberger K. Radiofrequency Microneedling for Skin Tightening of the Lower Face, Jawline, and Neck Region. Dermatol Surg. 2022 Dec 1;48(12):1299-1305. doi: 10.1097/DSS.0000000000003607. Epub 2022 Sep 29.</citation>
      <PMID>36449871</PMID>
    </reference>
    <reference>
      <citation>Wang JV, Christman MP, Feng H, Ferzli G, Jeon H, Geronemus RG. Laser-assisted delivery of tranexamic acid for melasma: Pilot study using a novel 1927 nm fractional thulium fiber laser. J Cosmet Dermatol. 2021 Jan;20(1):105-109. doi: 10.1111/jocd.13817. Epub 2020 Nov 11.</citation>
      <PMID>33174686</PMID>
    </reference>
    <reference>
      <citation>Lu K, Cai S. Efficacy and safety comparison between 1927 nm thulium laser and 2940 nm Er:YAG laser in the treatment of facial atrophic acne scarring: a prospective, simultaneous spilt-face clinical trial. Lasers Med Sci. 2022 Apr;37(3):2025-2031. doi: 10.1007/s10103-021-03465-0. Epub 2021 Nov 26.</citation>
      <PMID>34826022</PMID>
    </reference>
    <reference>
      <citation>Serra M, Bohnert K, Sadick N. A randomized, single-blind, study evaluating a 755-nm picosecond pulsed Alexandrite laser vs. a non-ablative 1927-nm fractionated thulium laser for the treatment of facial photopigmentation and aging. J Cosmet Laser Ther. 2018 Oct;20(6):335-340. doi: 10.1080/14764172.2018.1493513. Epub 2018 Jul 18.</citation>
      <PMID>30019970</PMID>
    </reference>
    <reference>
      <citation>Friedman PM, Dover JS, Chapas A, Rahman Z, Ross EV, Kilmer SL, Roberts WE, Sodha P, Stimmel JB, Moncrief MBC, Waibel JS. 1,550 nm Erbium-Doped and 1,927 nm Thulium Nonablative Fractional Laser System: Best Practices and Treatment Setting Recommendations. Dermatol Surg. 2022 Feb 1;48(2):195-200. doi: 10.1097/DSS.0000000000003321.</citation>
      <PMID>35050945</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universitätsklinikum Hamburg-Eppendorf</investigator_affiliation>
      <investigator_full_name>Lynhda Nguyen</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</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/NCT06029725
  org study id: 03-23
  nct id: NCT06029725
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The appearance of the aging skin is influenced by different factors including by the reduced
        elasticity and increased laxity of the skin, the decreasing volume as well as pigmentation
        disorders and dilated vascular markings. Currently, there are different methods available to
        treat the aging skin. Here, the combined treatment of radiofrequency micro needling (RFMN)
        and thulium laser has been commonly used in clinical practice.
  
        The aim of this clinical study is to investigate the efficacy, patient satisfaction, safety
        of RFMN and thulium laser treatment in patients with facial, age-related skin laxity,
        wrinkles, and pigmented lesions.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Change in wrinkles
  time frame: 6 months after last treatment session
  description: software-assisted evaluation of wrinkles (Vectra(R) Software, Canfield)
  measure: Change in volume
  time frame: 6 months after last treatment session
  description: software-assisted evaluation of volume (Vectra(R) Software, Canfield)
  measure: Change in pigmentation
  time frame: 6 months after last treatment session
  description: software-assisted evaluation of pigmentation (Vectra(R) Software, Canfield)
  measure: Pain intensity
  time frame: 10 minutes after starting each treatment session, one treatment session takes 30-50 minutes
  description: pain intensity (numeric rating scale) during treatment
  measure: Adverse Events
  time frame: before every treatment session, at every follow-up visit (3 and 6 months post-treatment)
  description: number of adverse events (AE)
  measure: Withdrawals due to AE
  time frame: before every treatment session, at every follow-up visit (3 and 6 months post-treatment)
  description: number of withdrawal due to AE
  arm group label: RFMN+Thulium
  arm group type: Active Comparator
  arm group label: RFMN
  arm group type: Active Comparator
  intervention type: Device
  intervention name: radiofrequency microneedling combined with 1927 nm thulium laser
  description: session: radiofrequency microneedling + 1927 nm thulium laser
  session: 1927 nm thulium laser monotherapy
  session: 1927 nm thulium laser monotherapy
  arm group label: RFMN+Thulium
  intervention type: Device
  intervention name: radiofrequency microneedling monotherapy
  description: 1 session: radiofrequency microneedling monotherapy
  arm group label: RFMN
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: L Nguyen
  phone: +49
  email: l.nguyen@uke.de
  facility: 
  contact: 
  country: Germany
  citation: Berneburg M, Plettenberg H, Krutmann J. Photoaging of human skin. Photodermatol Photoimmunol Photomed. 2000 Dec;16(6):239-44. doi: 10.1034/j.1600-0781.2000.160601.x.
  PMID: 11132125
  citation: el-Domyati M, el-Ammawi TS, Medhat W, Moawad O, Brennan D, Mahoney MG, Uitto J. Radiofrequency facial rejuvenation: evidence-based effect. J Am Acad Dermatol. 2011 Mar;64(3):524-35. doi: 10.1016/j.jaad.2010.06.045.
  PMID: 21315951
  citation: Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study. Arch Dermatol. 2004 Feb;140(2):204-9. doi: 10.1001/archderm.140.2.204.
  PMID: 14967794
  citation: Nguyen L, Blessmann M, Schneider SW, Herberger K. Radiofrequency Microneedling for Skin Tightening of the Lower Face, Jawline, and Neck Region. Dermatol Surg. 2022 Dec 1;48(12):1299-1305. doi: 10.1097/DSS.0000000000003607. Epub 2022 Sep 29.
  PMID: 36449871
  citation: Wang JV, Christman MP, Feng H, Ferzli G, Jeon H, Geronemus RG. Laser-assisted delivery of tranexamic acid for melasma: Pilot study using a novel 1927 nm fractional thulium fiber laser. J Cosmet Dermatol. 2021 Jan;20(1):105-109. doi: 10.1111/jocd.13817. Epub 2020 Nov 11.
  PMID: 33174686
  citation: Lu K, Cai S. Efficacy and safety comparison between 1927 nm thulium laser and 2940 nm Er:YAG laser in the treatment of facial atrophic acne scarring: a prospective, simultaneous spilt-face clinical trial. Lasers Med Sci. 2022 Apr;37(3):2025-2031. doi: 10.1007/s10103-021-03465-0. Epub 2021 Nov 26.
  PMID: 34826022
  citation: Serra M, Bohnert K, Sadick N. A randomized, single-blind, study evaluating a 755-nm picosecond pulsed Alexandrite laser vs. a non-ablative 1927-nm fractionated thulium laser for the treatment of facial photopigmentation and aging. J Cosmet Laser Ther. 2018 Oct;20(6):335-340. doi: 10.1080/14764172.2018.1493513. Epub 2018 Jul 18.
  PMID: 30019970
  citation: Friedman PM, Dover JS, Chapas A, Rahman Z, Ross EV, Kilmer SL, Roberts WE, Sodha P, Stimmel JB, Moncrief MBC, Waibel JS. 1,550 nm Erbium-Doped and 1,927 nm Thulium Nonablative Fractional Laser System: Best Practices and Treatment Setting Recommendations. Dermatol Surg. 2022 Feb 1;48(2):195-200. doi: 10.1097/DSS.0000000000003321.
  PMID: 35050945
  responsible party type: Principal Investigator
  investigator affiliation: Universitätsklinikum Hamburg-Eppendorf
  investigator full name: Lynhda Nguyen
  investigator title: Principle Investigator
  sharing ipd: No