A STUDY TO COMPARETHE EFFECTIVENESS AND SAFETY OF INTRALESIONAL VITAMIN D3 WITHINTRALESIONAL TRIAMCINOLONE IN PATIENTS WITH KELOIDS.
- Conditions
- Health Condition 1: L910- Hypertrophic scar
- Registration Number
- CTRI/2022/01/039579
- Lead Sponsor
- DEPARTMENT OF DERMATOLOGY PGIMER CHANDIGARH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patient with single keloid or multiple (upper limit 5) of more than 6-month duration. Every keloid selected for study is considered a different entity.
2. Keloids of size <10cm2 .
3. The patient who can give valid consent.
1. Patient with any previous interventional treatment for the same keloid in the 6 months preceding enrollment
2. Pregnant or lactating females or women who are planning a pregnancy
3. Keloids on the face
4. Immunosuppressed patients
5. Patient with chronic inflammatory diseases; patients with a history of renal or liver failure
6.Patients with a history of hypersensitivity to any of the study drugs
7. Patients with a history of non-responsiveness to any of the treatment modalities
8. The patient who is not willing to provide consent for the study.
9. Patient with active inflammation, infection, or ulcer in and around the keloid
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patient achieving 50% reduction in scar score by measuring the difference in Vancouver scar scale in the group receiving intralesional injection vitamin D3 versus the injection triamcinolone group.Timepoint: At the end of 4,8,12,16,24 weeks
- Secondary Outcome Measures
Name Time Method Adverse events during the treatmentTimepoint: At the end of 4,8,12,16,24 weeks;Mean difference in quality of life of patients before and after treatmentTimepoint: At the end of 4,8,12,16,24 weeks;To determine differences in VDR expression in keloid pathology by comparing tissue VDR expression pre and post-treatmentTimepoint: At the end of 4,8,12,16,24 weeks