Keloid Clinical Trial
Official title:
Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial
Verified date | June 2023 |
Source | Rumah Sakit Pusat Angkatan Darat Gatot Soebroto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a double-blind randomized controlled trial (RCT) examining the effect of intralesional injection of umbilical cord-derived mesenchymal stem cells (UC-MSC), umbilical cord-derived conditioned medium (UC-CM), or triamcinolone acetonide (TA) on keloids carried out using CONSORT statement. Research is directed at studying keloid volume reduction and changes in POSAS score.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 9, 2022 |
Est. primary completion date | June 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - The patient has keloids with a length of 2-10 cm and a thickness of 3-5 mm located on the chest, back, abdomen and extremities - Patients aged 18 - 55 years - Post-surgery patients more than 3 months that cause keloids - The patient is willing to fill in the informed consent form Exclusion Criteria: - Patients with hypertrophic scars - History of kidney failure - Hypertension - Pregnant and breastfeeding - History of blood disorders - History of tumor or malignancy - Get other keloid therapy outside of the research procedure |
Country | Name | City | State |
---|---|---|---|
Indonesia | RSPAD Gatot Soebroto | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto | Indonesia University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Keloid volume reduction | Volume was measured by CT-scan 2 weeks and 17 weeks after the first visit | 15 weeks | |
Primary | The Patient and Observer Scar Assessment Scale (POSAS) score reduction | Symptoms were measured using The Patient and Observer Scar Assessment Scale (POSAS) on the first visit, five weeks, 13 weeks, and 17 weeks after the first visit. Each item of the POSAS is rated on a 10-point score. The lowest score is '1', corresponding to the normal skin situation (i.e., normal pigmentation, no itching). Score 10 equals the most significant difference from normal skin (i.e., the worst imaginable scar or sensation). The symptoms are considered improved if the score gets lower. The total score of both scales can be calculated by summing up the scores of each of the six items. The total score can range from 6 to 60. | 17 weeks |
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