A STUDY TO COMPARETHE EFFECTIVENESS AND SAFETY OF INTRALESIONAL VITAMIN D3 WITHINTRALESIONAL TRIAMCINOLONE IN PATIENTS WITH KELOIDS.

Not yet recruiting

Conditions: Hypertrophic scar,

Registration Number: CTRI/2022/01/039579

Lead Sponsor: DEPARTMENT OF DERMATOLOGY PGIMER CHANDIGARH

Brief Summary: Pathological scars are acommon benign disorder. They are commonly seen among people with a racialpredisposition. Those with a history of burns, trauma, surgery, infections likefolliculitis and acne are more prone to develop pathological scars. Theseconsist of excess collagen deposition in scar tissue which leads to significantsymptoms like itching, pain, and cosmetic issues to the patient.

Hypertrophic scars arered, raised, or itchy lesions occurring as a result of burns or surgical woundsseen more in lighter-skinned people. On histology, organized type3 collagendeposition is seen.

Keloid scars areabnormal scars that appear as raised amorphous growth associated with pain anditching and extend beyond original wound boundaries. Despite treatment, there arechances of recurrence**,** nearly 100% recurrence is seen after surgical excisionbut surgical excision followed by postoperativeintralesional steroid injection seems to provide a reasonable treatment outcomewith a low recurrence rate.

Vitamin D is a fat-solublevitamin that is required for the human body. It is involved in calciumhomeostasis, cell proliferation inhibition, cell differentiation promotion,inflammation, and apoptosis. According to a study, reduced vitamin D receptor(VDR) expression and nuclear localization of VDR mayhave a role in keloid pathogenesis.2

So there is an assumption of a link between therole of VDR in keloid pathology and the efficacy of vitamin D as therapy in a keloidscar. There are no head-to-head comparisons of intralesional triamcinolone andintralesional vitamin D3 andhence we have endeavored to compare theeffectiveness and safety of these two treatment modalities in patients withkeloids.

***What is already knownon this topic?***

Keloid scars areabnormal scars that appear as raised amorphous growth associated with pain anditching and extend beyond original wound boundaries. Intralesional steroids arethe first line of treatment. Combination therapy have better role in cure andrecurrence. Also vitamin d3receptorshave role in keloidpathology.There are few pilot studies that have observed that vit d may help intreatment of keloids.

***What will this studyadd to existing knowledge?***

There are no studyregarding comparisons of intralesional triamcinolone and intralesional vitamin d3andhence we have endeavored to compare the effectiveness and safety ofthese two treatment modalities in patients with keloids.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 58

Inclusion Criteria

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.
Keloids of size <10cm2 .
The patient who can give valid consent.

Exclusion Criteria

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.
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.	At the end of 4,8,12,16,24 weeks

Secondary Outcome Measures

Name	Time	Method
To determine differences in VDR expression in keloid pathology by comparing tissue VDR expression pre and post-treatment	At the end of 4,8,12,16,24 weeks
Adverse events during the treatment	At the end of 4,8,12,16,24 weeks
Mean difference in quality of life of patients before and after treatment	At the end of 4,8,12,16,24 weeks

Trial Locations

Locations (1): DEPARTMENT OF DERMATOLOGY PGIMER CHANDIGARH
🇮🇳
Chandigarh, CHANDIGARH, India
DEPARTMENT OF DERMATOLOGY PGIMER CHANDIGARH
🇮🇳Chandigarh, CHANDIGARH, India
Dr Aman goyal
Principal investigator
9425719279
amangoyal0206@gmail.com