KeloidNCT06431360
Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid
A study testing hyperthermia in people with Keloid, run by Nanjing First Hospital, Nanjing Medical University at 2 sites in China.
Trial summary
Keloid patients were randomized into the experimental and control groups. Experimental group: Strontium-90 (Sr-90) brachytherapy followed by hyperthermia. Control group: Sr-90 brachytherapy alone . Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Keloid
- What is being tested?
- hyperthermia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 14 May 2024to 30 Jun 2025
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient was clinically diagnosed with keloid, and the keloid area was clean without rupture and exudation；
- Body surface keloid thickness: 2~5mm, diameter ≥10mm.
Who cannot join
- Women who plan to become pregnant within 3 months or are pregnant or breastfeeding;
- Patients with cicatricial constitution;
- Abnormal coagulation function;
- Patients who have received an adequate dose or course of radiation therapy;
- People with previous immune system diseases, diabetes and other metabolic diseases.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Feng Wang, Ph.D., 86-025-52271455, fengwangcn@hotmail.com
- Recruiting
The First Affiliated Hospital of Nanjing Medical Univerity
Nanjing, Jiangsu, 210006
Feng Wang, 86-025-52271455, fengwangcn@hotmail.com
Liang Shi, 86-025-52271491, liangshi@njmu.edu.cn
About this study
Keloid patients were randomized into the experimental and control groups. Experimental group: Strontium-90 (Sr-90) brachytherapy followed by hyperthermia. Control group: Sr-90 brachytherapy alone .
Read the detailed description
Sr-90 brachytherapy: 6-7 Gy each time, twice a week for 3 weeks; Hyperthermia: using a heater, 44℃ for 15 min
- Conditions
- Keloid
- Being tested
- hyperthermia
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperthermiaOther
Also called heater
hyperthermia (using a heater, 44℃for 15 min)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Sr-90 brachytherapy followed by hyperthermia. Receives: Other: hyperthermia |
| Control group | No intervention | Sr-90 brachytherapy alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Observer Scar Assessment Scale (POSAS) scores
The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.
comparable anatomic location.
Measured: once every 3 months for 1 year after the last treatment
Vancouver Scar Scale (VSS) scores
Physician evaluation comprised the use of the Vancouver Scar Scale (VSS) to evaluate the pigmentation (0=normal, 1=hypopigmented, 2=hyperpigmented), pliability (0=normal, 1= supple, 2=yielding, 3=firm, 4=banding, 5=contracture), height (0= flat, 1=5 mm), and vascularity (0=normal, 1=pink, 2=pink to red, 3=red, 4=red to purple, 5=purple).
Measured: once every 3 months for 1 year after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start14 May 2024
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2025 (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.
- More trials run by Nanjing First Hospital, Nanjing Medical 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Feng Wang, Study director, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431360
- Sponsor's protocol ID
- KY20240514-02
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 28 May 2024
- Results posted
- 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 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid
- ClinicalTrials.gov ID
- NCT06431360
- Acronym / sponsor ID
- KY20240514-02
- Conditions
- Keloid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 28 May 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.
Keloid patients were randomized into the experimental and control groups. Experimental group: Strontium-90 (Sr-90) brachytherapy followed by hyperthermia. Control group: Sr-90 brachytherapy alone .
Detailed description
Sr-90 brachytherapy: 6-7 Gy each time, twice a week for 3 weeks; Hyperthermia: using a heater, 44℃ for 15 min
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: hyperthermiaSr-90 brachytherapy followed by hyperthermia. |
| Control group | No intervention | –Sr-90 brachytherapy alone. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The patient was clinically diagnosed with keloid, and the keloid area was clean without rupture and exudation；
- Body surface keloid thickness: 2~5mm, diameter ≥10mm.
Key exclusion criteria (5 listed)
- Women who plan to become pregnant within 3 months or are pregnant or breastfeeding;
- Patients with cicatricial constitution;
- Abnormal coagulation function;
- Patients who have received an adequate dose or course of radiation therapy;
- People with previous immune system diseases, diabetes and other metabolic diseases.
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 |
|---|---|---|
| hyperthermiaAlso: heaterhyperthermia (using a heater, 44℃for 15 min) | Other | Experimental group |
Primary outcome
Patient and Observer Scar Assessment Scale (POSAS) scores
Time frame: once every 3 months for 1 year after the last treatment
The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location. comparable anatomic location.
Vancouver Scar Scale (VSS) scores
Time frame: once every 3 months for 1 year after the last treatment
Physician evaluation comprised the use of the Vancouver Scar Scale (VSS) to evaluate the pigmentation (0=normal, 1=hypopigmented, 2=hyperpigmented), pliability (0=normal, 1= supple, 2=yielding, 3=firm, 4=banding, 5=contracture), height (0= flat, 1=5 mm), and vascularity (0=normal, 1=pink, 2=pink to red, 3=red, 4=red to purple, 5=purple).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- 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.
Feng Wang study director
Nanjing First Hospital, Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperthermia in people with Keloid, run by Nanjing First Hospital, Nanjing Medical University at 2 sites 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 2 inclusion and 5 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 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Feng Wang (86-025-52271455, fengwangcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale (POSAS) scores (time frame: once every 3 months for 1 year after the last treatment). 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 28 May 2024.