Trial of Single Microneedle Radiofrequency for Moderate-to-Severe Acne Vulgaris

NCT04213638 | Unknown DMC

• 1 other identifier: 1120191113
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to testify the efficacy of treating moderate-to-severe acne vulgaris with Single Microneedle Radiofrequency, and provide evidence for the hypothesis that "whether Single Microneedle Radiofrequency therapy could be an alternative to photodynamic therapy for moderate to severe acne vulgaris."

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• The reduction rate of number of acne lesions

  Measure the reduction rate of number of acne lesions at 16 weeks after treatment compared with a baseline

  16 weeks

Study Arms (2)

Group：1

EXPERIMENTAL

Intervention: Other：Single Microneedle Radiofrequency therapy

Other: Single Microneedle Radiofrequency therapy

Group：2

ACTIVE COMPARATOR

Intervention: Other：Photodynamic therapy

Other: Photodynamic therapy

Interventions

Single Microneedle Radiofrequency therapy OTHER

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：1

Photodynamic therapy OTHER

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.

Group：2

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Consistent with the diagnostic criteria of moderate-to-severe acne vulgaris (IGA3-4) .
• Age of a subject is older than 14 and is younger than 45.（including 14 and 45）.
• Did not take any anti-acne treatment in the last 1 month, and did not take part in any clinical trial.
• Informed consent is signed by a subject or his lineal relation.

You may not qualify if:

• systemic acne treatment with oral isotretinoin within 6 months or oral antibiotics in the past 1 month;
• history of facial procedures like dermabrasion, chemical, or laser peels;
• history of photosensitive diseases, porphyria, or porphyrin sensitivity.
• With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
• Pregnant women or women in lactation.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiang Ya Hospital Central South University

Changsha, Hunan, 410000, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 26955297 BACKGROUND

• 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.

  PMID: 31126563 BACKGROUND

• 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.

  PMID: 31654468 BACKGROUND

• 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.

  PMID: 31502662 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: December 30, 2019
• Study Start: November 15, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

CN (1)