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

NCT06378983 | Recruiting

• 1 other identifier: SYSKY-2023-1149-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moderate to Severe Acne Vulgaris

Keywords

microneedle radiofrequency; isotretinoin; acne vulgaris

Outcome Measures

Primary Outcomes (2)

• Changes in ECCA acne scar score from baseline at week 20

  Two experienced dermatologists who are in a blind state will evaluate the patient's ECCA score. If the results are inconsistent, the third evaluator will evaluate and serve as the final result.

  week 20

• The percentage of effective skin lesion clearance rate in the 20th week

  Two experienced dermatologists who are in a blind state will perform facial skin lesion counting on the patient. If the results are inconsistent, the third evaluator will evaluate and serve as the final result.

  week 20

Study Arms (2)

oral isotretinoin combined with microneedle radiofrequency therapy group

EXPERIMENTAL

Oral isotretinoin was administered using the same method as the isotretinoin group, while microneedle radiofrequency therapy was also administered.Using the Peninsula radiofrequency therapy device (Peninsula Company, China). A total of 3 treatments were conducted, with a treatment interval of 1 month, and the total course of treatment was 8 weeks.

Other: Oral isotretinoin combined with microneedle radiofrequency therapy

oral isotretinoin alone group

OTHER

Oral isotretinoin capsules at a dose of 10mg/time, once per day, orally, for a total course of 8 weeks.

Drug: Oral isotretinoin

Interventions

Oral isotretinoin DRUG

Oral isotretinoin

Also known as: Control group

oral isotretinoin alone group

Oral isotretinoin combined with microneedle radiofrequency therapy OTHER

Oral isotretinoin combined with microneedle radiofrequency therapy

Also known as: Experimental group

oral isotretinoin combined with microneedle radiofrequency therapy group

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide a signed and dated informed consent form before conducting any research related processes
• Male and female aged 14-65
• Patients clinically diagnosed with moderate to severe acne vulgaris (according to the Chinese Acne Treatment Guidelines, revised in 2019) must meet the Pillsbury International Modified Classification (see Appendix 5), which belongs to level II-III, and the IGA (Investigator Global Assessment) assessed by the study physician as moderate (3) or severe (4)
• Type III-IV skin according to Fitzpatrick scale
• Adhere to all lifestyle precautions throughout the entire study period and refrain from using other acne treatment drugs, etc.

You may not qualify if:

• Pregnant women or women planning to conceive during the study period, pregnant or lactating women, and fertile female subjects who are unable to use or do not plan to use medically acceptable contraceptive measures. Male subjects who do not plan to use medically acceptable contraceptive measures.
• For women with fertility: did not use medically approved contraceptive measures for at least one month prior to screening, and did not agree to use medically approved contraceptive measures during the study period or within 30 days after the end of study drug use.
• Individuals who currently meet any of the following conditions in clinical practice: aggregate acne, fulminant acne, secondary acne (drug-induced acne), or any facial skin condition or facial hair that may interfere with clinical evaluation (such as sideburns, sideburns, beard). The following types of skin diseases that can interfere with the evaluation of acne vulgaris include folliculitis, rosacea, demodex, pustular vasculitis, mechanical acne, occupational acne including oily or tar acne, as well as chloroacne, facial disseminated lupus lesions, etc.
• Facial sunburn
• Researchers believe that laboratory values or electrocardiogram examinations with clinically significant abnormalities should be screened, including but not limited to the following situations (if the screening period test results are difficult to explain, according to the researcher's judgment, a repeated measurement is allowed): 1) Fasting blood glucose is greater than the upper limit of normal values; 2) Creatine kinase is greater than or equal to twice the upper limit of normal value; 3) Liver function (AST or ALT) greater than 1.5 times the upper limit of normal value; 4) Creatinine is higher than the upper limit of normal value; 5) Female pregnancy test positive; 6) Abnormal ECG examination has clinical significance.
• Participated in clinical studies of other drugs and devices within the first three months of screening;
• Select subjects who have undergone major surgery (i.e. require general anesthesia) within the first 12 weeks, have not fully recovered from surgery, or are expected to undergo surgery during the study period.
• Subjects with any of the following medical histories should be excluded: 1) those who are allergic to isotretinoids or any component of the investigational drug, or have a history of multiple drug allergies; 2) known or suspected precancerous lesions or malignant diseases, including a history of malignant tumors within the previous 5 years of screening (such as evidence of any tumor activity within the past 5 years, or diagnosed with malignant tumors within that period, excludingSkin cancer treated with Gong therapy.
• Subjects who have used any of the following drugs before enrollment in the study, or who are currently using these drugs and have not completed the washout period as required below: Note: The washout period should be calculated from the expected randomization date (day 0). The random allocation date can be adjusted to ensure that the subjects complete the washout period.1) Within one week before randomization: all medical skincare products with acne relieving effects; 2) Within 2 weeks before randomization: topical acne treatment drugs, including but not limited to: topical corticosteroids; External use of retinoic acid drugs; Topical application of benzoyl peroxide; Topical antibiotics (clindamycin; erythromycin; lincomycin, etc.); External use of azelaic acid drugs; 3) Within the first 4 weeks of randomization: laser and photodynamic therapy; Antibiotics used throughout the body (tetracyclines, macrolides, etc.); Finasteride; Systemic use of sex hormones (estrogen, progesterone, and progesterone); Chinese medicine or traditional Chinese patent medicines and simple preparations for acne treatment; Immunosuppressants (cyclosporine/Tripterygium wilfordii/Methotrexate, etc.); Immunomodulators (glycyrrhizic acid glycoside/tanshinone/berberine, etc.) 4) Within the first 12 weeks of randomization: systemic administration of isotretinoids; Use corticosteroids throughout the body; Biological agents with immunomodulatory effects, such as omalizumab.
• Subjects with severe liver, kidney, cardiovascular, respiratory, endocrine, hematological, urinary, metabolic, central nervous system, or autoimmune diseases.
• Screening shows a history of drug abuse and alcohol abuse within the first 2 years.
• The research center personnel and/or their immediate family members who directly participated in this study. Immediate relatives refer to spouses, parents, children or siblings (who are related by blood or legally adopted).
• Other situations that the researcher deems unsuitable for participation in the study.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University.

Guangzhou, 510030, China

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sha Lu

  Department of Dermatology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Sha Lu

CONTACT

13632383399; lush7@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: April 23, 2024
• Study Start: September 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

CN (1)