A comparative study to compare laser and injection therapy vs injection treatment alone in treating keloids.

Not yet recruiting

• Conditions: Other hypertrophic disorders of the skin,

• Registration Number: CTRI/2023/10/058276
• Lead Sponsor: DrULavanya

Brief Summary

Keloids represent an excessive connective tissue response to injury.Its a benign well demarcated overgrowth of fibrotic tissue which extends beyond the original boundaries of a defect.These are cosmetically distressing,painful or pruritic.

A scar at any site has the potential to become keloidal although the earlobes,chin,neck are vulnerable.Burns,scars or tissue infection lead to hypertrophic scarring.Lesions may follow trivial trauma or inflammatory lesions like acne.Sometimes,keloids can occur spontaneously patlrticularly on upper chest.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-10
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All clinically diagnosed cases of keloid .
• Patients who are willing to give informed consent.

Exclusion Criteria

• Before starting the study.
• Patients who are pregnant or lactating. Patients planning for pregnancy. Patients with history of intake of oral retinoids in the past 6 months. Patients with signs of active infection or lesions suspicious of malignancy. Patients with diseases or genetic conditions causing photosensitivity or tending to aggravate after light exposure. Patients with co-morbidities- DM,SHT,TB,CAD,EPILEPSY,BA. Patients on Photosensitizing drugs,immunosuppressive drugs,anti coagulants. Bleeding and coagulation disorders,HIV. During Study.
• If patient develops severe side effects like ulceration / intolerance to pain during the treatment. If patient wants alternate treatment during the study. If patient wants to discontinue the treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The end point will be the evaluation of clinical response to both the mode of treatment at 36 weeks after treatment initiation	4 weeks
Responses in between the study will be noticed recorded using Modified Vancouver Scar Scale(MVSS) Physicians Global Assessment (PGA) scale Patients overall satisfaction score	4 weeks

Secondary Outcome Measures

Name	Time	Method
Safety profile	36 weeks

Trial Locations

Locations (1)

Government chengalpattu medical college; 🇮🇳 Kancheepuram, TAMIL NADU, India

Government chengalpattu medical college

🇮🇳Kancheepuram, TAMIL NADU, India

Lavanya

Principal investigator

9444767687

lavsravi0306@gmail.com