<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/NCT03264287</url>
  </required_header>
  <id_info>
    <org_study_id>GAMHospital20170301</org_study_id>
    <nct_id>NCT03264287</nct_id>
  </id_info>
  <brief_title>Efficacy of Acupuncture Combined With Moving Cupping and Ear Point Tapping for Moderate and Severe Acne Vulgaris</brief_title>
  <official_title>Efficacy of Acupuncture Combined With Moving Cupping and Ear Point Tapping for Moderate and Severe Acne Vulgaris: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is designed to evaluate the efficacy of different frequencies in treating the&#xD;
      moderate and severe acne vulgaris using acupuncture combined with moving cupping and ear&#xD;
      point tapping.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Acne vulgaris is a common skin disease, especially in adolescents and young&#xD;
      adults. Acne affects approximately 85% of teenagers, but can occur in most age groups and can&#xD;
      persist into adulthood. There is no mortality associated with acne, but there is often&#xD;
      significant physical and psychological morbidity. Acupuncture combined with moving cupping&#xD;
      and ear point tapping may effectively relieve the skin lesions, but the evidence is limited.&#xD;
      Also, young patients usually have no time to see the doctor frequently, thus it's necessary&#xD;
      to figure out a better frequency of treating.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IGA success rate</measure>
    <time_frame>Baseline, week 1-6</time_frame>
    <description>The proportion of subjects who achieved at least a two-point reduction from baseline to week 6 in IGA(Investigator's Global Assessment, scale from 0 to 5) score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of IGA (Investigator's Global Assessment) score from baseline</measure>
    <time_frame>Baseline, week 6, week 18, week 30</time_frame>
    <description>After 6 weeks treating, the IGA(Investigator's Global Assessment, scale from 0 to 5) score's change from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of the Visual Analogue Scale (VAS) for facial pruritus from baseline</measure>
    <time_frame>Baseline, week 6, week 18, week 30</time_frame>
    <description>VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no itch, and 100 mm represents unbearable itch. Patients will rate the VAS (average VAS of facial itch in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of itch over weeks 1-6 will be calculated as the sum VAS of each week divided by the number of weeks assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of the Visual Analogue Scale (VAS) for facial lesion pain from baseline.</measure>
    <time_frame>Baseline, week 6, week 18, week 30</time_frame>
    <description>Visual Analogue Scale (VAS)VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no pain, and 100 mm represents unbearable pain. Patients will rate the VAS (average VAS of facial pain in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of pain over weeks 1-6 will be calculated as the sum VAS of each week divided by the number of weeks assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of the Total Lesion Count (TLC) on the face from baseline.</measure>
    <time_frame>Baseline, week 6, week 18, week 30</time_frame>
    <description>TLC is the sum of the inflammatory and non-inflammatory counts, including comedones, papules and pustules, nodules and cysts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of the Inflammatory Lesions (IN) on the face from baseline.</measure>
    <time_frame>Baseline, week 6, week 18, week 30</time_frame>
    <description>IN is the sum of papules, pustules, nodules and cysts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of the Skindex-16 dermatologic survey score from baseline.</measure>
    <time_frame>Baseline, week 6, week 18, week 30</time_frame>
    <description>Skindex-16 is a dermatologic quality-of-life survey. There are 16 questions in this survey. It concerns the skin condition which has bothered the patient the most during the past week. This survey calculated from 3 aspects including symptoms, emotions and functions. The score of each question is 0 to 6 points, and multiply by 16.6667，and get the sum of 16 questions' score. The average of the sum of 16 questions' score is the final result of skindex-16 dermatology survey. When the score is higher, it means the disease has greater influence on the patient.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>3 times per week therapeutic frequency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.Acupuncture: GV20, LU5, LI11, LI4,GV14,BL13, ST2, BL2,ST7,ST6 and ashi point on the face.&#xD;
Huatuo Brand needle (0.20*13mm) will be used for GV14, BL13, ST2, BL2, ST7, ST6 and ashi point on the face. Huatuo Brand needle (0.3*40mm) will be used for GV20, LU5, LI11 and LI4.&#xD;
2.Moving capping: Du Meridian (from GV14 to GV3) as well as the first (from BL11 to BL28) and second (from BL41 to BL53) side lines of the Urinary Bladder Meridian of Foot-Taiyang.&#xD;
Guoyiyan Brand cupping jar (size 4) will be used. 3.Ear point tapping: Lung (CO14), Heart (CO15), Stomach (CO4), Neifenmi (CO18), Pizhixia (AT4).&#xD;
Huatuo Brand, made by the seed of Vaccaria segetalis ( Neck.)Garcke.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1 time per week therapeutic frequency</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The acupoints and treating procedures will be the same as the 3 times per week group. Only treating frequency is different. The treating frequency is 1 time per week.&#xD;
Acupuncture: GV20, LU5, LI11, LI4,GV14,BL13, ST2, BL2,ST7,ST6 and ashi point on the face.&#xD;
Moving capping: Du Meridian (from GV14 to GV3) as well as the first (from BL11 to BL28) and second (from BL41 to BL53) side lines of the Urinary Bladder Meridian of Foot-Taiyang.&#xD;
Ear point tapping: Lung (CO14), Heart (CO15), Stomach (CO4), Neifenmi (CO18), Pizhixia (AT4).&#xD;
Use the seed of Vaccaria segetalis ( Neck.)Garcke.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>3 times per week therapeutic frequency</intervention_name>
    <description>Participants will receive acupuncture, moving cupping and ear-tapping procedure 3 times per week over the 6 weeks period.</description>
    <arm_group_label>3 times per week therapeutic frequency</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>1 time per week therapeutic frequency</intervention_name>
    <description>Participants will receive acupuncture, moving cupping and ear-tapping procedure 1 time per week over the 6 weeks period.</description>
    <arm_group_label>1 time per week therapeutic frequency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed as acne vulgaris.&#xD;
&#xD;
          -  GAGS score between 19 and 38 points.&#xD;
&#xD;
          -  Age of 15 to 35 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other types of acne: acne conglobate, acne fulminans，acne medicamentosa, premenstrual&#xD;
             acne，cosmetic acne and trade acne.&#xD;
&#xD;
          -  Presence of any other systemic disease that could affect the acne severity by its&#xD;
             presence, such as polycystic ovarian syndrome, or thyroid diseases, or atypical&#xD;
             congenital adrenal hyperplasia；or by any medication prescribed for the treatment of&#xD;
             the systemic diseases.&#xD;
&#xD;
             -- Use of any topical acne treatment or systemic antibiotics or traditional Chinese&#xD;
             medicine within 2 weeks before study initiation. Use of a systemic retinoid within 9&#xD;
             months before study initiation. Use of a systemic steroid within 9 months before study&#xD;
             initiation. Presence of any change in the use of oral contraceptive pills or&#xD;
             anti-inflammatory drugs within 3 months before study initiation.&#xD;
&#xD;
          -  Presence of any other skin disease that could interfere with the assessment of the&#xD;
             acne, such as folliculitis or rosacea.&#xD;
&#xD;
          -  Presence of severe heart, liver, kidney or hematopoietic system diseases, as well as&#xD;
             severe malnutrition.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Recent use of this research scheme within 4 weeks before study initiation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chang Xie, Bachelor</last_name>
    <phone>+86 13261958032</phone>
    <email>craby616@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhishun Liu, Doctor</last_name>
    <phone>010-88002331</phone>
    <email>liuzhishun@aliyun.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chang Xie, Bachelor</last_name>
      <phone>+86 13261958032</phone>
      <email>craby616@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.</citation>
    <PMID>9248884</PMID>
  </reference>
  <reference>
    <citation>Song BH, Lee DH, Kim BC, Ku SH, Park EJ, Kwon IH, Kim KH, Kim KJ. Photodynamic therapy using chlorophyll-a in the treatment of acne vulgaris: a randomized, single-blind, split-face study. J Am Acad Dermatol. 2014 Oct;71(4):764-71. doi: 10.1016/j.jaad.2014.05.047. Epub 2014 Jun 12.</citation>
    <PMID>24930587</PMID>
  </reference>
  <reference>
    <citation>Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE, Leyden JJ, Reynolds RV, Silverberg NB, Stein Gold LF, Tollefson MM, Weiss JS, Dolan NC, Sagan AA, Stern M, Boyer KM, Bhushan R. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17. Erratum In: J Am Acad Dermatol. 2020 Jun;82(6):1576.</citation>
    <PMID>26897386</PMID>
  </reference>
  <reference>
    <citation>Jung JY, Hong JS, Ahn CH, Yoon JY, Kwon HH, Suh DH. Prospective randomized controlled clinical and histopathological study of acne vulgaris treated with dual mode of quasi-long pulse and Q-switched 1064-nm Nd:YAG laser assisted with a topically applied carbon suspension. J Am Acad Dermatol. 2012 Apr;66(4):626-33. doi: 10.1016/j.jaad.2011.08.031. Epub 2011 Oct 26.</citation>
    <PMID>22033354</PMID>
  </reference>
  <reference>
    <citation>Eichenfield LF, Jarratt M, Schlessinger J, Kempers S, Manna V, Hwa J, Liu Y, Graeber M; Adapalene Lotion Study Group. Adapalene 0.1% lotion in the treatment of acne vulgaris: results from two placebo-controlled, multicenter, randomized double-blind, clinical studies. J Drugs Dermatol. 2010 Jun;9(6):639-46.</citation>
    <PMID>20645525</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 3, 2017</last_update_submitted>
  <last_update_submitted_qc>September 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Chang Xie</investigator_full_name>
    <investigator_title>Postgraduate student of Beijing University of Chinese Medicine &amp; Guang'anmen Hospital of China Academy of Chinese Medical Sciences</investigator_title>
  </responsible_party>
  <keyword>acne vulgaris</keyword>
  <keyword>acupuncture</keyword>
  <keyword>cupping</keyword>
  <keyword>ear point tapping</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03264287
org study id: GAMHospital20170301
nct id: NCT03264287
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial is designed to evaluate the efficacy of different frequencies in treating the
      moderate and severe acne vulgaris using acupuncture combined with moving cupping and ear
      point tapping.
Background: Acne vulgaris is a common skin disease, especially in adolescents and young
      adults. Acne affects approximately 85% of teenagers, but can occur in most age groups and can
      persist into adulthood. There is no mortality associated with acne, but there is often
      significant physical and psychological morbidity. Acupuncture combined with moving cupping
      and ear point tapping may effectively relieve the skin lesions, but the evidence is limited.
      Also, young patients usually have no time to see the doctor frequently, thus it's necessary
      to figure out a better frequency of treating.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: IGA success rate
time frame: Baseline, week 1-6
description: The proportion of subjects who achieved at least a two-point reduction from baseline to week 6 in IGA(Investigator's Global Assessment, scale from 0 to 5) score
measure: The change of IGA (Investigator's Global Assessment) score from baseline
time frame: Baseline, week 6, week 18, week 30
description: After 6 weeks treating, the IGA(Investigator's Global Assessment, scale from 0 to 5) score's change from baseline.
measure: The change of the Visual Analogue Scale (VAS) for facial pruritus from baseline
time frame: Baseline, week 6, week 18, week 30
description: VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no itch, and 100 mm represents unbearable itch. Patients will rate the VAS (average VAS of facial itch in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of itch over weeks 1-6 will be calculated as the sum VAS of each week divided by the number of weeks assessed.
measure: The change of the Visual Analogue Scale (VAS) for facial lesion pain from baseline.
time frame: Baseline, week 6, week 18, week 30
description: Visual Analogue Scale (VAS)VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no pain, and 100 mm represents unbearable pain. Patients will rate the VAS (average VAS of facial pain in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of pain over weeks 1-6 will be calculated as the sum VAS of each week divided by the number of weeks assessed.
measure: The change of the Total Lesion Count (TLC) on the face from baseline.
time frame: Baseline, week 6, week 18, week 30
description: TLC is the sum of the inflammatory and non-inflammatory counts, including comedones, papules and pustules, nodules and cysts.
measure: The change of the Inflammatory Lesions (IN) on the face from baseline.
time frame: Baseline, week 6, week 18, week 30
description: IN is the sum of papules, pustules, nodules and cysts.
measure: The change of the Skindex-16 dermatologic survey score from baseline.
time frame: Baseline, week 6, week 18, week 30
description: Skindex-16 is a dermatologic quality-of-life survey. There are 16 questions in this survey. It concerns the skin condition which has bothered the patient the most during the past week. This survey calculated from 3 aspects including symptoms, emotions and functions. The score of each question is 0 to 6 points, and multiply by 16.6667，and get the sum of 16 questions' score. The average of the sum of 16 questions' score is the final result of skindex-16 dermatology survey. When the score is higher, it means the disease has greater influence on the patient.
arm group label: 3 times per week therapeutic frequency
arm group type: Experimental
description: 1.Acupuncture: GV20, LU5, LI11, LI4,GV14,BL13, ST2, BL2,ST7,ST6 and ashi point on the face.
Huatuo Brand needle (0.20*13mm) will be used for GV14, BL13, ST2, BL2, ST7, ST6 and ashi point on the face. Huatuo Brand needle (0.3*40mm) will be used for GV20, LU5, LI11 and LI4.
2.Moving capping: Du Meridian (from GV14 to GV3) as well as the first (from BL11 to BL28) and second (from BL41 to BL53) side lines of the Urinary Bladder Meridian of Foot-Taiyang.
Guoyiyan Brand cupping jar (size 4) will be used. 3.Ear point tapping: Lung (CO14), Heart (CO15), Stomach (CO4), Neifenmi (CO18), Pizhixia (AT4).
Huatuo Brand, made by the seed of Vaccaria segetalis ( Neck.)Garcke.
arm group label: 1 time per week therapeutic frequency
arm group type: Active Comparator
description: The acupoints and treating procedures will be the same as the 3 times per week group. Only treating frequency is different. The treating frequency is 1 time per week.
Acupuncture: GV20, LU5, LI11, LI4,GV14,BL13, ST2, BL2,ST7,ST6 and ashi point on the face.
Moving capping: Du Meridian (from GV14 to GV3) as well as the first (from BL11 to BL28) and second (from BL41 to BL53) side lines of the Urinary Bladder Meridian of Foot-Taiyang.
Ear point tapping: Lung (CO14), Heart (CO15), Stomach (CO4), Neifenmi (CO18), Pizhixia (AT4).
Use the seed of Vaccaria segetalis ( Neck.)Garcke.
intervention type: Procedure
intervention name: 3 times per week therapeutic frequency
description: Participants will receive acupuncture, moving cupping and ear-tapping procedure 3 times per week over the 6 weeks period.
arm group label: 3 times per week therapeutic frequency
intervention type: Procedure
intervention name: 1 time per week therapeutic frequency
description: Participants will receive acupuncture, moving cupping and ear-tapping procedure 1 time per week over the 6 weeks period.
arm group label: 1 time per week therapeutic frequency
criteria: 
gender: All
minimum age: 15 Years
maximum age: 35 Years
healthy volunteers: No
last name: Chang Xie, Bachelor
phone: +86 13261958032
email: craby616@163.com
last name: Zhishun Liu, Doctor
phone: 010-88002331
email: liuzhishun@aliyun.com
facility: 
status: Recruiting
contact: 
country: China
citation: Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.
PMID: 9248884
citation: Song BH, Lee DH, Kim BC, Ku SH, Park EJ, Kwon IH, Kim KH, Kim KJ. Photodynamic therapy using chlorophyll-a in the treatment of acne vulgaris: a randomized, single-blind, split-face study. J Am Acad Dermatol. 2014 Oct;71(4):764-71. doi: 10.1016/j.jaad.2014.05.047. Epub 2014 Jun 12.
PMID: 24930587
citation: Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE, Leyden JJ, Reynolds RV, Silverberg NB, Stein Gold LF, Tollefson MM, Weiss JS, Dolan NC, Sagan AA, Stern M, Boyer KM, Bhushan R. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17. Erratum In: J Am Acad Dermatol. 2020 Jun;82(6):1576.
PMID: 26897386
citation: Jung JY, Hong JS, Ahn CH, Yoon JY, Kwon HH, Suh DH. Prospective randomized controlled clinical and histopathological study of acne vulgaris treated with dual mode of quasi-long pulse and Q-switched 1064-nm Nd:YAG laser assisted with a topically applied carbon suspension. J Am Acad Dermatol. 2012 Apr;66(4):626-33. doi: 10.1016/j.jaad.2011.08.031. Epub 2011 Oct 26.
PMID: 22033354
citation: Eichenfield LF, Jarratt M, Schlessinger J, Kempers S, Manna V, Hwa J, Liu Y, Graeber M; Adapalene Lotion Study Group. Adapalene 0.1% lotion in the treatment of acne vulgaris: results from two placebo-controlled, multicenter, randomized double-blind, clinical studies. J Drugs Dermatol. 2010 Jun;9(6):639-46.
PMID: 20645525
responsible party type: Principal Investigator
investigator affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
investigator full name: Chang Xie
investigator title: Postgraduate student of Beijing University of Chinese Medicine & Guang'anmen Hospital of China Academy of Chinese Medical Sciences
mesh term: Acne Vulgaris
sharing ipd: Undecided