Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378983
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-02-20
Brief Title:
Clinical Trial of Microneedle Radiofrequency Combined With Oral Isotretinoin in Moderate to Severe Acne
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study plans to select 100 AV patients and randomly divide them into two groups in a 11 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None