KeloidKBTNCT07835438
Transdermal Versus Intralesional Betamethasone for Keloids
A study testing Compound betamethasone and Medium-frequency Therapeutic Device in people with Keloid, run by First Hospital of China Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- Compound betamethasone and Medium-frequency Therapeutic Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 29 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 informed consent and comply with follow-up visits.
Who cannot join
- 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 2 weeks: topical anti-scar medications.
- Within 4 weeks: laser therapy, immunosuppressive agents (e.g., 5-fluorouracil), or systemic antibiotics (e.g., tetracyclines, macrolides).
- Within 8 weeks: intralesional Diprospan or triamcinolone injection.
- Within 12 weeks: biologic agents with immunomodulatory effects (e.g., monoclonal antibodies).
Show all 11Show fewer
- Within 6 months: radiotherapy or botulinum toxin injection. 3. Known allergy or contraindication 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 contraception.
- 6. Patients with severe systemic diseases or abnormal laboratory findings that make them unsuitable for the study (e.g., serious organ disease or active autoimmune disease).
- 7. Refusal to sign informed consent. 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: A Randomized Controlled Study on the Efficacy and Safety of Transdermal Delivery of Compound Betamethasone Via a Medium-Frequency Device Versus Intralesional Injection in Patients With Keloids
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.
Read the detailed description
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.
- Conditions
- Keloid
- Being tested
- Compound betamethasone, Medium-frequency Therapeutic Device
- Keywords
- keloid, Betamethasone, Transdermal delivery, Medium-frequency therapy, Intralesional injection
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound betamethasoneDrug
Compound betamethasone will be administered either via intralesional injection or transdermal delivery using a medium-frequency therapeutic device.
Medium-frequency Therapeutic DeviceDevice
A medium-frequency therapeutic device will be used to facilitate transdermal delivery of compound betamethasone into keloid lesions.
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Injection Group | Active comparator | 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. Receives: Drug: Compound betamethasone |
| Transdermal Delivery Group | Experimental | 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. Receives: Drug: Compound betamethasone; Device: Medium-frequency Therapeutic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 weeks after the final treatment
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 52
Incidence of Adverse Events
The number and severity of treatment-related adverse events will be recorded throughout the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start25 Apr 2025
- Primary completion16 Jun 2026
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xinghua, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835438
- Sponsor's protocol ID
- FAH-CMU-2025-keloids-01
- Acronym
- KBT
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Efficacy and Safety of Transdermal Delivery of Compound Betamethasone Via a Medium-Frequency Device Versus Intralesional Injection in Patients With Keloids
- ClinicalTrials.gov ID
- NCT07835438
- Acronym / sponsor ID
- KBT / FAH-CMU-2025-keloids-01
- Conditions
- Keloid
- Keywords
- keloid, Betamethasone, Transdermal delivery, Medium-frequency therapy, Intralesional injection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 23 Sep 2026 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional Injection Group | Active comparator | Drug: Compound betamethasoneParticipants 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. |
| Transdermal Delivery Group | Experimental | Drug: Compound betamethasone, Device: Medium-frequency Therapeutic DeviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 informed consent and comply with follow-up visits.
Key exclusion criteria (11 listed)
- 1. Active infection of keloids (e.g., itching, pain, ulceration, suppuration), unhealed wounds, or other skin conditions that may affect efficacy evaluation.
- Within 2 weeks: topical anti-scar medications.
- Within 4 weeks: laser therapy, immunosuppressive agents (e.g., 5-fluorouracil), or systemic antibiotics (e.g., tetracyclines, macrolides).
- Within 8 weeks: intralesional Diprospan or triamcinolone injection.
- Within 12 weeks: biologic agents with immunomodulatory effects (e.g., monoclonal antibodies).
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 |
|---|---|---|
| Compound betamethasoneCompound betamethasone will be administered either via intralesional injection or transdermal delivery using a medium-frequency therapeutic device. | Drug | Intralesional Injection Group, Transdermal Delivery Group |
| Medium-frequency Therapeutic DeviceA medium-frequency therapeutic device will be used to facilitate transdermal delivery of compound betamethasone into keloid lesions. | Device | Transdermal Delivery Group |
Primary outcome
Improvement Rate in Vancouver Scar Scale (VSS) Total Score at 24 Weeks After the Final Treatment
Time frame: Baseline and 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.
25 secondary outcomes
Improvement Rate of Vancouver Scar Scale (VSS) Score at Multiple Time Points
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
Time frame: At the first, second, and third treatment visits, and at 24 and 52 weeks after the final treatment
Patient Satisfaction Score
Time frame: 24 and 52 weeks after the final treatment
Pain Intensity Assessed Using the Verbal Rating Scale (VRS)
Time frame: At each follow-up visit through 52 weeks after the final treatment
Dermatology Life Quality Index (DLQI) Total Score
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
Recurrence Rate
Time frame: Up to Week 52
Incidence of Adverse Events
Time frame: Baseline to Week 52
Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score
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)
Time frame: At each follow-up visit through 52 weeks after the final treatment
Skindex-29 Symptoms Domain Score
Time frame: Baseline, Week 4, Week 24, and Week 52
Skindex-29 Emotions Domain Score
Time frame: Baseline, Week 4, Week 24, and Week 52
Skindex-29 Functioning Domain Score
Time frame: Baseline, Week 4, Week 24, and Week 52
36-Item Short Form Health Survey (SF-36) Physical Functioning Domain Score
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compound betamethasone and Medium-frequency Therapeutic Device in people with Keloid, run by First Hospital of China Medical 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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement Rate in Vancouver Scar Scale (VSS) Total Score at 24 Weeks After the Final Treatment (time frame: Baseline and 24 weeks after the final treatment). 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 Sep 2026.