<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/NCT04433143</url>
  </required_header>
  <id_info>
    <org_study_id>XijingH-PF-20202021-F-1</org_study_id>
    <nct_id>NCT04433143</nct_id>
  </id_info>
  <brief_title>Evaluate the Efficacy and Safety of Intense Pulsed Light Filters Combined With Oral Medication in the Treatment of Acne</brief_title>
  <official_title>To Evaluate the Efficacy and Safety of Different Intense Pulsed Light Filters Combined With Oral Medication in the Treatment of Moderate to Severe Acne</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gang Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</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>
      1. Acne is a chronic inflammatory disease involving the hair follicles and sebaceous&#xD;
           glands, characterized by acne, papules, pustules, nodules, and cysts. Acne often occurs&#xD;
           in sebum overflow areas such as the face, chest, back and so on. It is a common skin&#xD;
           lesion, which not only affects physical health, but also brings psychological disorders&#xD;
           and psychosocial problems to patients. At present, the common treatment methods of acne&#xD;
           include health education, topical drugs, oral drugs and medical cosmetic treatment.&#xD;
&#xD;
        2. Intense pulsed light has been widely accepted as a non-invasive and non-serious&#xD;
           treatment for acne. The M22 strong light and laser system Acne filter has a wavelength&#xD;
           of 400-600/800-1200nm.&#xD;
&#xD;
        3. Although there are many treatments for acne, the slow response and easy recurrence of&#xD;
           acne are still common problems that trouble doctors and patients. We clinically use&#xD;
           drugs combined with intense pulsed light treatment, and the efficacy of the patients is&#xD;
           fair, but currently lack of clinical research data support. This study intends to&#xD;
           evaluate the effectiveness of different methods in the treatment of moderate and severe&#xD;
           acne by evaluating different bands of intense pulsed light combined with drugs, and to&#xD;
           observe whether the treatment with oral tetracycline antibiotics combined with intense&#xD;
           pulsed light is safe.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The M22 strong light and laser system Acne filter has a wavelength of 400-600/800-1200nm. The&#xD;
      light in the 400-600nm band is targeted at the superficial skin inflammation, while&#xD;
      800-1200nm is targeted at the deep sebaceous gland inflammation. The skin can produce&#xD;
      oxidation reaction to form singlet oxygen to eliminate propionibacterium acnes after&#xD;
      absorption of porphyrin at 400nm. The light of 800-1200nm band can penetrate into the deep&#xD;
      layer of sebaceous glands, and the thermal contraction of sebaceous glands can improve the&#xD;
      anaerobic environment of bacteria, which is not conducive to the reproduction of bacteria.&#xD;
      Meanwhile, when the temperature of sebaceous glands reaches 40 degrees Celsius, bacteria can&#xD;
      be killed directly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Anticipated">May 6, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 6, 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acne IGA rating scale</measure>
    <time_frame>change from week0 to week24</time_frame>
    <description>The severity of the facial rash is evaluated according to the number of skin rashes, with a score of 0-5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain score</measure>
    <time_frame>week0，week4，week8</time_frame>
    <description>The pain is rated on a scale of 1 to 10</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>oral medication</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>just oral minocycline hydrochloride capsules (100mg/ time, once per day),</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intense Pulsed Light single filter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intense pulsed Acne filter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intense Pulsed Light two filters</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intense pulsed light Acne filter and another filter (560nm, 590nm or 640nm filter)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Minocycline hydrochloride capsules were taken orally</intervention_name>
    <description>Lumenis OneTM, OPT tender system produced by American Medical Science Company; Use four of the filters. Acne filter has a wavelength of 400-600/800-1200nm. Three pulses were used for treatment, with a pulse width of 5.0ms, a pulse delay of 30ns, and an energy density of 15j /cm2. The instrument parameters were selected according to the skin lesion characteristics, age and tolerance.</description>
    <arm_group_label>Intense Pulsed Light single filter</arm_group_label>
    <arm_group_label>Intense Pulsed Light two filters</arm_group_label>
    <arm_group_label>oral medication</arm_group_label>
    <other_name>Intense Pulsed Light</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-40, regardless of gender; The patient agrees to participate in this trial and&#xD;
             signs the informed consent Clinical diagnosis of acne (moderate and severe) No&#xD;
             bleeding, rupture, infection or other conditions affecting the visual field of laser&#xD;
             surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons with facial dermatitis and sensitive skin; Relevant treatment within 1 month,&#xD;
             including topical drugs, oral drugs, medical cosmetic treatment; Those with a history&#xD;
             of exposure to the sun in recent January; Persons with scar constitution; Skin&#xD;
             malignant tumor or precancerous lesion; Diabetes, heart disease, epilepsy, connective&#xD;
             tissue disease, etc.; Pregnant or breastfeeding; Recent skin infections (such as&#xD;
             viruses; Bacteria); Those who are using other methods to treat similar diseases;&#xD;
             Others are not suitable for enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dermatology Derpartment of Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>Gang Wang</investigator_full_name>
    <investigator_title>Head of Dermatology</investigator_title>
  </responsible_party>
  <keyword>Acne Vulgaris</keyword>
  <keyword>Intense Pulsed Light</keyword>
  <keyword>Oral Medication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Minocycline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04433143
org study id: XijingH-PF-20202021-F-1
nct id: NCT04433143
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
1. Acne is a chronic inflammatory disease involving the hair follicles and sebaceous
           glands, characterized by acne, papules, pustules, nodules, and cysts. Acne often occurs
           in sebum overflow areas such as the face, chest, back and so on. It is a common skin
           lesion, which not only affects physical health, but also brings psychological disorders
           and psychosocial problems to patients. At present, the common treatment methods of acne
           include health education, topical drugs, oral drugs and medical cosmetic treatment.

        2. Intense pulsed light has been widely accepted as a non-invasive and non-serious
           treatment for acne. The M22 strong light and laser system Acne filter has a wavelength
           of 400-600/800-1200nm.

        3. Although there are many treatments for acne, the slow response and easy recurrence of
           acne are still common problems that trouble doctors and patients. We clinically use
           drugs combined with intense pulsed light treatment, and the efficacy of the patients is
           fair, but currently lack of clinical research data support. This study intends to
           evaluate the effectiveness of different methods in the treatment of moderate and severe
           acne by evaluating different bands of intense pulsed light combined with drugs, and to
           observe whether the treatment with oral tetracycline antibiotics combined with intense
           pulsed light is safe.
The M22 strong light and laser system Acne filter has a wavelength of 400-600/800-1200nm. The
      light in the 400-600nm band is targeted at the superficial skin inflammation, while
      800-1200nm is targeted at the deep sebaceous gland inflammation. The skin can produce
      oxidation reaction to form singlet oxygen to eliminate propionibacterium acnes after
      absorption of porphyrin at 400nm. The light of 800-1200nm band can penetrate into the deep
      layer of sebaceous glands, and the thermal contraction of sebaceous glands can improve the
      anaerobic environment of bacteria, which is not conducive to the reproduction of bacteria.
      Meanwhile, when the temperature of sebaceous glands reaches 40 degrees Celsius, bacteria can
      be killed directly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Acne IGA rating scale
time frame: change from week0 to week24
description: The severity of the facial rash is evaluated according to the number of skin rashes, with a score of 0-5
measure: Pain score
time frame: week0，week4，week8
description: The pain is rated on a scale of 1 to 10
arm group label: oral medication
arm group type: Experimental
description: just oral minocycline hydrochloride capsules (100mg/ time, once per day),
arm group label: Intense Pulsed Light single filter
arm group type: Experimental
description: Intense pulsed Acne filter
arm group label: Intense Pulsed Light two filters
arm group type: Experimental
description: Intense pulsed light Acne filter and another filter (560nm, 590nm or 640nm filter)
intervention type: Drug
intervention name: Minocycline hydrochloride capsules were taken orally
description: Lumenis OneTM, OPT tender system produced by American Medical Science Company; Use four of the filters. Acne filter has a wavelength of 400-600/800-1200nm. Three pulses were used for treatment, with a pulse width of 5.0ms, a pulse delay of 30ns, and an energy density of 15j /cm2. The instrument parameters were selected according to the skin lesion characteristics, age and tolerance.
arm group label: Intense Pulsed Light single filter
arm group label: Intense Pulsed Light two filters
arm group label: oral medication
other name: Intense Pulsed Light
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Xijing Hospital
investigator full name: Gang Wang
investigator title: Head of Dermatology
mesh term: Acne Vulgaris
mesh term: Minocycline
sharing ipd: No