A clinical trial to study the effects of drug named Triamcinolone alone or combination of Triamcinolone and 5- Fluorouracil in patients with Keloid or hypertrophic scars

Phase 4

Completed

• Conditions: Keloids; Hypertrophic scars; Skin - Other skin conditions

• Registration Number: ACTRN12612000546853
• Lead Sponsor: Farrukh Aslam Khalid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Age above 12 years/either sex
Keloid or hypertrophic scar more than 10mm in size measured clinically

Exclusion Criteria

History of treatment for scar taken in last 6 months
History of chronic renal failure or serum creatinine > 1.2mg/dl.
Abnormalities in liver function tests (ALT > 35 IU) and blood counts (WBC < 4 or > 11 thousand cells) on laboratory investigations.
Pregnant/lactating women or planning pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of intralesional TAC and combination of TAC with 5-FU in the treatment of keloid and hypertrophic scars for mean reduction in scar height[at 4, 8 weeks of treatment and 4 weeks after the end of treatment]

Secondary Outcome Measures

Name	Time	Method
To compare the complications with intralesional TAC alone with that of combination of TAC with 5-FU in the treatment of keloid and hypertrophic scars like skin atrophy, telangiectasias, hypo or hyperpigmentation and skin ulceration by clinical observation by separate investigator[during clinical visits for treatment by a separate investigator for presence of above complications and then again assessed at 4 weeks after treatment.]