An interventional study of Compound betamethasone and Medium-frequency Therapeutic Device in Keloid, sponsored by First Hospital of China Medical University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by First Hospital of China Medical University · Not applicable, Interventional, and Treatment
This study aims to evaluate the efficacy and safety of transdermal delivery of compound betamethasone using a medium-frequency device compared with intralesional injection in the treatment of keloids. A total of 45 patients will be enrolled and assigned in a 1:2 ratio to either the intralesional injection group or the transdermal delivery group. Participants will receive three treatment sessions over an 8-week period. Clinical outcomes will be assessed using the Vancouver Scar Scale (VSS), Patient and Observer Scar Assessment Scale (POSAS), and patient-reported outcomes at multiple follow-up time points up to 52 weeks. Safety will be evaluated through monitoring of adverse events, vital signs, and laboratory tests.
Keloids are benign fibroproliferative skin disorders characterized by excessive collagen deposition and abnormal scar growth beyond the boundaries of the original wound. Intralesional injection of compound betamethasone is a commonly used treatment for keloids; however, repeated injections are often associated with pain and poor patient tolerance.
This study is a randomized, open-label, single-center clinical trial designed to evaluate the efficacy and safety of transdermal delivery of compound betamethasone using a medium-frequency therapeutic device compared with conventional intralesional injection in patients with keloids.
A total of 45 participants with clinically diagnosed keloids will be enrolled and randomized in a 1:2 ratio into two groups: an intralesional injection group and a transdermal delivery group. Participants in the control group will receive intralesional injections of compound betamethasone directly into keloid lesions. Participants in the experimental group will receive transdermal delivery of compound betamethasone using a medium-frequency therapeutic device.
All participants will receive three treatment sessions over an 8-week treatment period and will be followed for up to 52 weeks. The primary outcome is the improvement rate of Vancouver Scar Scale (VSS) scores at Week 24 compared with baseline. Secondary outcomes include Patient and Observer Scar Assessment Scale (POSAS) scores, pain and pruritus assessed by Verbal Rating Scale (VRS), patient satisfaction, quality of life measures, recurrence rate, and incidence of adverse events.
This study aims to determine whether transdermal delivery of compound betamethasone using a medium-frequency therapeutic device provides comparable or superior efficacy with improved tolerability compared with conventional intralesional injection for the treatment of keloids.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 45 is above the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →First Hospital of China Medical University is the lead sponsor of 62 studies on the registry; 34 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Participants diagnosed with keloids by investigators according to established clinical criteria.
2. At least one keloid lesion with a maximum diameter greater than 0.5 cm. 3. Duration of keloid ≥ 6 months (mature keloid). 4. Age ≥ 18 years. 5. Fitzpatrick skin types II-IV. 6. Participants who are suitable for both intralesional injection of Diprospan and transdermal drug delivery using a medium-frequency therapeutic device.
7. Participants seeking improvement in the appearance of keloids. 8. Willing to participate and able to provide written and comply with follow-up visits.
Exclusion Criteria:
1. Active infection of keloids (e.g., itching, pain, ulceration, suppuration), unhealed wounds, or other skin conditions that may affect efficacy evaluation.
2. Use of the following treatments within specified timeframes prior to randomization:
Within 6 months: radiotherapy or botulinum toxin injection. 3. Known allergy or to Diprospan. 4. History of coagulation disorders or current/planned use of anticoagulant, antiplatelet, or thrombolytic therapy (e.g., warfarin, aspirin).
5. Pregnant or breastfeeding women, or those planning pregnancy or unwilling to use .
6. Patients with severe systemic diseases or abnormal laboratory findings that make them unsuitable for the study (e.g., serious organ disease or active disease).
7. Refusal to sign . 8. Inability to communicate or comply with study procedures (e.g., cognitive impairment, psychiatric or neurological disorders).
9. Any other condition deemed unsuitable by the investigator. 10. Inability to adhere to treatment schedule or follow-up for personal or other reasons.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive intralesional injections of compound betamethasone directly into keloid lesions at predefined intervals over 8 weeks for a total of three treatment sessions.
Drug: Compound betamethasone
Participants in this group will receive transdermal delivery of compound betamethasone using a medium-frequency therapeutic device over an 8-week period for a total of three sessions.
Drug: Compound betamethasone · Device: Medium-frequency Therapeutic Device
Drug pages: Betamethasone sodium phosphate · Betamethasone dipropionate
Compound betamethasone will be administered either via intralesional injection or transdermal delivery using a medium-frequency therapeutic device.
A medium-frequency therapeutic device will be used to facilitate transdermal delivery of compound betamethasone into keloid lesions.
Improvement Rate in Vancouver Scar Scale (VSS) Total Score at 24 Weeks After the Final Treatment
The version of the Vancouver Scar Scale (VSS) used in this study assesses four scar characteristics: color, thickness, vascularity, and pliability. Color is scored from 0 to 3, thickness from 0 to 4, vascularity from 0 to 3, and pliability from 0 to 5. The total VSS score ranges from 0 to 15. Higher scores indicate greater scar severity and therefore a worse outcome. The primary outcome is the improvement rate in the VSS total score at 24 weeks after the final treatment compared with baseline.
Time frame: Baseline and 24 weeks after the final treatment
Improvement Rate of Vancouver Scar Scale (VSS) Score at Multiple Time Points
The improvement rate of Vancouver Scar Scale (VSS) scores compared with baseline will be assessed at multiple time points to evaluate treatment efficacy over time.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, and Week 52
Patient and Observer Scar Assessment Scale (POSAS) Patient Scale Total Score
The Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) consists of six items, each scored from 1 to 10. The total score ranges from 6 to 60. Lower scores indicate scar characteristics more similar to normal skin, whereas higher scores indicate a greater difference from normal skin and therefore a worse outcome.
Time frame: At the first, second, and third treatment visits, and at 24 and 52 weeks after the final treatment
Patient Satisfaction Score
Patient satisfaction is assessed using a 5-point patient satisfaction rating scale ranging from 0 to 4: 0 = no improvement/poor, 1 = slightly dissatisfied, 2 = neutral, 3 = generally satisfied, and 4 = very satisfied. Higher scores indicate greater patient satisfaction and therefore a better outcome.
Time frame: 24 and 52 weeks after the final treatment
Pain Intensity Assessed Using the Verbal Rating Scale (VRS)
Pain intensity is assessed using the Verbal Rating Scale (VRS), with scores ranging from 0 to 4: 0 = no pain, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. Higher scores indicate greater pain intensity and therefore a worse outcome.
Time frame: At each follow-up visit through 52 weeks after the final treatment
Dermatology Life Quality Index (DLQI) Total Score
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire assessing the impact of skin disease on health-related quality of life. The total score ranges from 0 to 30. Higher scores indicate greater impairment in quality of life and therefore a worse outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
Recurrence Rate
The recurrence rate of keloids will be evaluated within 1 year after treatment based on predefined clinical criteria.
Time frame: Up to Week 52
Incidence of Adverse Events
The number and severity of treatment-related adverse events will be recorded throughout the study.
Time frame: Baseline to Week 52
Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score
The Observer Scale of the Patient and Observer Scar Assessment Scale (POSAS) consists of five items, each scored from 1 to 10. The total score ranges from 5 to 50. Lower scores indicate scar characteristics more similar to normal skin, whereas higher scores indicate a greater difference from normal skin and therefore a worse outcome.
Time frame: At the first, second, and third treatment visits, and at 24 and 52 weeks after the final treatment
Pruritus Intensity Assessed Using the Verbal Rating Scale (VRS)
Pruritus intensity is assessed using the Verbal Rating Scale (VRS), with scores ranging from 0 to 4: 0 = no pruritus, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. Higher scores indicate greater pruritus intensity and therefore a worse outcome.
Time frame: At each follow-up visit through 52 weeks after the final treatment
Skindex-29 Symptoms Domain Score
The Skindex-29 is a dermatology-specific health-related quality-of-life questionnaire. The Symptoms domain score ranges from 0 to 100. Higher scores indicate greater symptom-related impairment in quality of life and therefore a worse outcome.
Time frame: Baseline, Week 4, Week 24, and Week 52
Skindex-29 Emotions Domain Score
The Skindex-29 is a dermatology-specific health-related quality-of-life questionnaire. The Emotions domain score ranges from 0 to 100. Higher scores indicate greater emotional impairment related to the skin condition and therefore a worse outcome.
Time frame: Baseline, Week 4, Week 24, and Week 52
Skindex-29 Functioning Domain Score
The Skindex-29 is a dermatology-specific health-related quality-of-life questionnaire. The Functioning domain score ranges from 0 to 100. Higher scores indicate greater impairment in daily and social functioning related to the skin condition and therefore a worse outcome.
Time frame: Baseline, Week 4, Week 24, and Week 52
36-Item Short Form Health Survey (SF-36) Physical Functioning Domain Score
The Physical Functioning domain of the 36-Item Short Form Health Survey (SF-36) assesses limitations in physical activities due to health. The domain score ranges from 0 to 100. Higher scores indicate better physical functioning and therefore a better outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
36-Item Short Form Health Survey (SF-36) Role Limitations Due to Physical Health Domain Score
The Role Limitations Due to Physical Health domain of the 36-Item Short Form Health Survey (SF-36) assesses limitations in work or other daily activities caused by physical health problems. The domain score ranges from 0 to 100. Higher scores indicate fewer role limitations and therefore a better outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
36-Item Short Form Health Survey (SF-36) Bodily Pain Domain Score
The Bodily Pain domain of the 36-Item Short Form Health Survey (SF-36) assesses pain intensity and interference with normal activities. The domain score ranges from 0 to 100. Higher scores indicate less pain and less pain-related interference and therefore a better outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
36-Item Short Form Health Survey (SF-36) General Health Domain Score
The General Health domain of the 36-Item Short Form Health Survey (SF-36) assesses participants' perceptions of their overall health. The domain score ranges from 0 to 100. Higher scores indicate better perceived general health and therefore a better outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
36-Item Short Form Health Survey (SF-36) Vitality Domain Score
The Vitality domain of the 36-Item Short Form Health Survey (SF-36) assesses energy and fatigue. The domain score ranges from 0 to 100. Higher scores indicate greater vitality and less fatigue and therefore a better outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
36-Item Short Form Health Survey (SF-36) Social Functioning Domain Score
The Social Functioning domain of the 36-Item Short Form Health Survey (SF-36) assesses the extent to which physical or emotional health interferes with normal social activities. The domain score ranges from 0 to 100. Higher scores indicate better social functioning and therefore a better outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
36-Item Short Form Health Survey (SF-36) Role Limitations Due to Emotional Problems Domain Score
The Role Limitations Due to Emotional Problems domain of the 36-Item Short Form Health Survey (SF-36) assesses limitations in work or other daily activities caused by emotional problems. The domain score ranges from 0 to 100. Higher scores indicate fewer role limitations and therefore a better outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
36-Item Short Form Health Survey (SF-36) Mental Health Domain Score
The Mental Health domain of the 36-Item Short Form Health Survey (SF-36) assesses psychological well-being and emotional distress. The domain score ranges from 0 to 100. Higher scores indicate better mental health and therefore a better outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
Symptom Checklist-90 (SCL-90) Total Score
The Symptom Checklist-90 (SCL-90) is a 90-item self-report questionnaire used to assess a broad range of psychological symptoms. Each item is scored from 1 to 5, where higher item scores indicate greater symptom severity. The total score ranges from 90 to 450. Higher total scores indicate greater psychological distress and therefore a worse outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
9-Item Hamilton Depression Rating Scale (HAMD) Total Score
The 9-item version of the Hamilton Depression Rating Scale (HAMD) used in this study assesses depressed mood, feelings of guilt, suicidality, difficulty falling asleep, disturbed sleep, early-morning awakening, work and interests, psychomotor retardation, and agitation. Items are scored on either a 0-to-4 or 0-to-2 scale, yielding a total score ranging from 0 to 28. Higher scores indicate greater severity of depressive symptoms and therefore a worse outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
Hamilton Anxiety Rating Scale (HAMA) Total Score
The Hamilton Anxiety Rating Scale (HAMA) consists of 14 items assessing psychological and somatic symptoms of anxiety. Each item is scored from 0 to 4, where 0 indicates no symptoms and 4 indicates very severe symptoms. The total score ranges from 0 to 56. Higher scores indicate greater severity of anxiety symptoms and therefore a worse outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
Keloid-Specific Quality of Life Questionnaire Physical Domain Score
The keloid-specific quality of life questionnaire used in this study includes a Physical Domain consisting of five items assessing physical impairment related to keloids, including pain, pruritus, and limitations in daily activities. Each item is scored on a six-level scale using values of -5, -3, -1, 1, 3, and 5. The domain score is calculated as the arithmetic mean of the item scores and ranges from -5 to 5. Higher scores indicate greater physical impairment related to keloids and therefore a worse outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
Keloid-Specific Quality of Life Questionnaire Psychological Domain Score
The keloid-specific quality of life questionnaire used in this study includes a Psychological Domain consisting of nine items assessing the psychological and social impact of keloids, including embarrassment, self-image, concealment, social discomfort, and self-confidence. Each item is scored on a six-level scale using values of -5, -3, -1, 1, 3, and 5. The domain score is calculated as the arithmetic mean of the item scores and ranges from -5 to 5. Higher scores indicate greater psychological impairment related to keloids and therefore a worse outcome.
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
Plan to share: No
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Ran from Apr 2025 to primary completion in Jun 2026, 13 months.
Of 20 interventional studies with no phase under Keloid, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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First Hospital of China Medical University