Moderate to Severe Acne VulgarisNCT06378983
Clinical Trial of Microneedle Radiofrequency Combined With Oral Isotretinoin in Moderate to Severe Acne
A study testing Oral isotretinoin and Oral isotretinoin combined with microneedle radiofrequency therapy in people with Moderate to Severe Acne Vulgaris, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Moderate to Severe Acne Vulgaris
- What is being tested?
- Oral isotretinoin and Oral isotretinoin combined with microneedle radiofrequency therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
Guangzhou, 510030
Sha Lu, 13632383399, lush7@mail.sysu.edu.cn
About this study
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
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.
Read the 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
- Being tested
- Oral isotretinoin, Oral isotretinoin combined with microneedle radiofrequency therapy
- Keywords
- microneedle radiofrequency, isotretinoin, acne vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral isotretinoinDrug
Also called Control group
Oral isotretinoin
Oral isotretinoin combined with microneedle radiofrequency therapyOther
Also called Experimental group
Oral isotretinoin combined with microneedle radiofrequency therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oral isotretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Sep 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sha Lu, Study director, Department of Dermatology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378983
- Sponsor's protocol ID
- SYSKY-2023-1149-02
- Status last verified
- Apr 2024
- First submitted
- 20 Feb 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06378983
- Acronym / sponsor ID
- SYSKY-2023-1149-02
- Conditions
- Moderate to Severe Acne Vulgaris
- Keywords
- microneedle radiofrequency, isotretinoin, acne vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral isotretinoin combined with microneedle radiofrequency therapy group | Experimental | Other: Oral isotretinoin combined with microneedle radiofrequency therapyOral 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. |
| oral isotretinoin alone group | Other | Drug: Oral isotretinoinOral isotretinoin capsules at a dose of 10mg/time, once per day, orally, for a total course of 8 weeks. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral isotretinoinAlso: Control groupOral isotretinoin | Drug | oral isotretinoin alone group |
| Oral isotretinoin combined with microneedle radiofrequency therapyAlso: Experimental groupOral isotretinoin combined with microneedle radiofrequency therapy | Other | oral isotretinoin combined with microneedle radiofrequency therapy group |
Primary outcome
Changes in ECCA acne scar score from baseline at week 20
Time frame: 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.
The percentage of effective skin lesion clearance rate in the 20th week
Time frame: week 20
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
Related trials for Moderate to Severe Acne Vulgaris
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Active, not recruitingPhase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1)
Hidradenitis Suppurativa
Active, not recruitingPhase 3
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruitingPhase 2/3
A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sha Lu study director
Department of Dermatology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral isotretinoin and Oral isotretinoin combined with microneedle radiofrequency therapy in people with Moderate to Severe Acne Vulgaris, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sha Lu (13632383399, lush7@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ECCA acne scar score from baseline at week 20 (time frame: week 20). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.