NCT06378983

Clinical Trial of Microneedle Radiofrequency Combined With Oral Isotretinoin in Moderate to Severe Acne

A Single Center, Prospective Randomized Controlled Clinical Trial on the Efficacy and Safety of Microneedle Radiofrequency Combined With Oral Isotretinoin in Moderate to Severe Acne Vulgaris

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study plans to select 100 AV patients and randomly divide them into two groups in a 1:1 ratio: the experimental group will be treated with MRF combined with oral isotretinoic acid for 8 consecutive weeks, with a total of 3 MRF treatments at weeks 1, 4, and 8. The control group received oral administration of isotretinoic acid alone for 8 weeks. The main observation indicators are the percentage of effective skin injury clearance achieved by subjects at week 20, as well as the change in ECCA acne scar score compared to baseline at week 20. I hope this study can clarify that the combination therapy of the two can achieve the effects of improving efficacy, shortening treatment course, reducing recurrence, not increasing adverse reactions, and reducing the risk of scar formation.

Detailed description

Acne vulgaris (AV) is a chronic inflammatory skin disease that is prone to damage during adolescence. Based on the damage to appearance, it has a negative impact on the psychological and daily life of AV patients, increasing their economic burden. Isoretinoic acid is currently an oral medication targeting the four key pathological and physiological stages of AV, but adverse reactions are common, safe and effective, and the treatment or drug letter that can prevent scar formation remains unclear. Our preliminary research has confirmed that microneedle radiofrequency therapy (MRF) can effectively treat AV and improve post AV pigmentation and scar formation. To further confirm the efficacy and safety of MRF combined with oral isotretinoic acid in the treatment of moderate to severe AV, we plan to conduct a randomized, oral controlled prospective clinical study. This study plans to select 100 AV patients and randomly assign them to two groups in a 1:1 ratio: the experimental group was treated with MRF combined with oral isotretinoin for 8 weeks of continuous oral medication, and a total of 3 MRF sessions were conducted at weeks 1, 4, and 8. The control group was treated with oral isotretinoin alone for 8 weeks. The main observation indicators are the percentage of effective skin lesion clearance rate achieved by subjects at week 20, as well as the change in ECCA acne scar score from baseline at week 20. It is hoped that this study can clarify that the combination therapy of the two can achieve the effects of improving efficacy, shortening treatment course, reducing recurrence, not increasing adverse reactions, and reducing the risk of scar formation.

Conditions

• Moderate to Severe Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Oral isotretinoin	Oral isotretinoin
OTHER	Oral isotretinoin combined with microneedle radiofrequency therapy	Oral isotretinoin combined with microneedle radiofrequency therapy

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2024-04-23
• Last updated: 2024-04-23

Locations

1 site across 1 country: China