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A prospective, multicenter, randomized, parallel controlled, non inferiority clinical trial evaluating the efficacy and safety of a radiofrequency microneedle therapy device (model: D1) for treating atrophic scars in acne

A prospective, multicenter, randomized, parallel controlled, non inferiority clinical trial evaluating the efficacy and safety of a radiofrequency microneedle therapy device (model: D1) for treating atrophic scars in acne

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102803
Enrollment
Unknown
Registered
2025-05-20
Start date
2025-02-07
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne atrophic scars

Interventions

Test group:Using D1 type radiofrequency microneedle therapy device for treatment.
Control group:Using INTRAcel type radiofrequency microneedle therapy device for treatment

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age range of 18 to 60 years old (including boundaries); 2. Acne atrophic scars >= 1 year and ECCA score >= 60; 3.Voluntarily participate in this trial, willing to complete subsequent follow-up, and sign a written informed consent form

Exclusion criteria

Exclusion criteria: 1. Those who have received treatments such as radiofrequency, laser, intense pulsed light, chemical exfoliation, fillers, etc. in the treatment area within 3 months; 2. People with scar constitution; 3. Patients allergic to local anesthetics; 4. Skin diseases such as damaged, open wounds, purulent wounds, and active inflammatory herpes in the treatment area; 5. Patients with serious internal and external diseases such as cardiovascular and cerebrovascular diseases, tumors, epilepsy, herpes simplex, autoimmune diseases, hemorrhagic diseases, or coagulation disorders, or those equipped with electronic devices such as pacemakers and defibrillators; 6. Those who suffer from mental illness or have other underlying reasons that prevent them from completing treatment or follow-up plans; 7. Pregnant women or those who are breastfeeding; 8. During other clinical trial research periods; 9. There may be situations where other researchers determine that participation in the study may result in adverse outcomes for patients.

Design outcomes

Primary

MeasureTime frame
Improvement value of ECCA score 12 weeks after the last treatment;

Secondary

MeasureTime frame
ECCA score improvement value;VISIA Skin Testing Analysis;GAIS rating;VAS rating;Subject Satisfaction Questionnaire;

Countries

China

Contacts

Public ContactXiang Wen, Xiaoxi Lin

West China Hospital, Sichuan University/The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

xiangwen_wcums@163.com+86 189 8060 6449

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026