Trial of Single Microneedle Radiofrequency for Moderate-to-Severe Acne Vulgaris
NCT ID: NCT04213638
Last Updated: 2019-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
122 participants
INTERVENTIONAL
2019-11-15
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group：1
Intervention: Other：Single Microneedle Radiofrequency therapy
Single Microneedle Radiofrequency therapy
Subjects are treated with three consecutive sessions of Single Microneedle Radiofrequency therapy at 2-week intervals, with a follow-up visit 12 weeks after the final third treatment. Each treatment session took approximately 30-60 minutes.
Group：2
Intervention: Other：Photodynamic therapy
Photodynamic therapy
Subjects are treated with three consecutive sessions of Photodynamic therapy at 2-week intervals, with a follow-up visit 12 weeks after the final third treatment.
Interventions
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Single Microneedle Radiofrequency therapy
Subjects are treated with three consecutive sessions of Single Microneedle Radiofrequency therapy at 2-week intervals, with a follow-up visit 12 weeks after the final third treatment. Each treatment session took approximately 30-60 minutes.
Photodynamic therapy
Subjects are treated with three consecutive sessions of Photodynamic therapy at 2-week intervals, with a follow-up visit 12 weeks after the final third treatment.
Eligibility Criteria
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Inclusion Criteria
2. Age of a subject is older than 14 and is younger than 45.（including 14 and 45）.
3. Did not take any anti-acne treatment in the last 1 month, and did not take part in any clinical trial.
4. Informed consent is signed by a subject or his lineal relation.
Exclusion Criteria
2. history of facial procedures like dermabrasion, chemical, or laser peels;
3. history of photosensitive diseases, porphyria, or porphyrin sensitivity.
4. With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
5. Pregnant women or women in lactation.
14 Years
45 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
Responsible Party
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Locations
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Xiang Ya Hospital Central South University
Changsha, Hunan, China
Countries
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Facility Contacts
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Dan Jian, Doctor
Role: primary
References
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Lynn DD, Umari T, Dunnick CA, Dellavalle RP. The epidemiology of acne vulgaris in late adolescence. Adolesc Health Med Ther. 2016 Jan 19;7:13-25. doi: 10.2147/AHMT.S55832. eCollection 2016.
Xing M, Yan X, Sun X, Wang S, Zhou M, Zhu B, Kuai L, Liu L, Luo Y, Li X, Li B. Fire needle therapy for moderate-severe acne: A PRISMA systematic review and meta-analysis of randomized controlled trials. Complement Ther Med. 2019 Jun;44:253-260. doi: 10.1016/j.ctim.2019.04.009. Epub 2019 Apr 28.
Tang X, Li C, Ge S, Chen Z, Lu L. Efficacy of photodynamic therapy for the treatment of inflammatory acne vulgaris: A systematic review and meta-analysis. J Cosmet Dermatol. 2020 Jan;19(1):10-21. doi: 10.1111/jocd.13197. Epub 2019 Oct 25.
Ahn GR, Kim JM, Park SJ, Li K, Kim BJ. Selective Sebaceous Gland Electrothermolysis Using a Single Microneedle Radiofrequency Device for Acne Patients: A Prospective Randomized Controlled Study. Lasers Surg Med. 2020 Jun;52(5):396-401. doi: 10.1002/lsm.23152. Epub 2019 Sep 10.
Other Identifiers
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1120191113
Identifier Type: -
Identifier Source: org_study_id