Intralesional Triamcinolone Acetonide and Its Combination With 5-fluorouracil in Keloids and Hypertrophic Scars

NCT04812626 | Completed DMC

• 1 other identifier: BPK
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Summary: Keloids and hypertrophic scars are benign fibrous growth, differing mainly by overgrowth beyond the initial defect in keloid whereas hypertrophic scar is confined to initial lesion and tends to regress over the years. Keloids and hypertrophic scars mainly lead to cosmetic disfigurement and functional deformity depending on site of involvement, in addition to symptoms like pain and pruritus, encountered occasionally. These sometimes might lead to psychological impact too. Different treatment options for keloids and hypertrophic scar are silicone gel/ sheets, corticosteroids, cryotherapy, lasers, antineoplastic agents (5-FU, mitomycin-C), surgical excision and immunomodulators (imiquimod) used either as monotherapy or combination therapy. Different studies involving combination of TAC and 5-FU have been done so far which shows better treatment outcome in terms of efficacy and safety. In a recent meta-analysis published in 2017 concluded that combination therapy of 5-FU + TAC offers better outcome than TAC alone, however recommended additional randomized, controlled, large-sample, high quality trial are needed for a more objective analysis of the treatment efficacy and to assess the adverse reaction associated. We are conducting this study the objective to compare the efficacy and safety profile of intralesional triamcinolone acetonide alone and its combination with 5-FU of the treatment of keloids and hypertrophic scars. This study may help in finding out the optimum treatment option in keloid and hypertrophic scar with minimal side effects in our clinical practice.

Conditions

Scar Keloid

Outcome Measures

Primary Outcomes (4)

• Percentage of change in height of scar pre and post treatment in each groups

  Compare the change in height in millimeter of scar pre and post treatment in percentages in each treatment groups

  Starting of treatment to 12 weeks follow up of treatment

• Percentage of reduction in The Patient and Observer Scar Assessment Score) score in two treatment groups

  Compare the reduction in The Patient and Observer Scar Assessment Score from baseline to 12 week follow up in each group in percentage

  Starting of treatment to 12 weeks follow up of treatment

• Percentage of change in Vancouver Scar Scale score in two treatment groups

  Compare the change in Vancouver Scar Scale from baseline to 12 week follow up in each group in percentage

  Starting of treatment to 12 weeks follow up of treatment

• Percentage of good to excellent subjective improvement in two groups combination with 5-flurouracil in the treatment of keloids and hypertrophic scars at 12 weeks follow up

  Compare the good to excellent improvement (\>50% subjective improvement) in the scars in two treatment groups in percentage

  Starting of treatment to 12 weeks follow up of treatment

Secondary Outcomes (1)

• Percentages of Side effects of treatment groups

  Starting of treatment to 12 weeks follow up of treatment

Study Arms (2)

Group A: Intralesional (IL) triamcinolone acetonide (TAC) alone;

EXPERIMENTAL

Group A: 1 ml of 40mg/ml triamcinolone acetonide will be mixed with 1ml of normal saline. 5 units (0.125ml) of the mixture will be given intralesional with the help of 1ml insulin syringe of 40units,covering an area of 0.5X0.5 cm2 of scar. Each extra area of 0.5x0.5cm2 will be given 5 units of injection of above mixture of drugs( maximum dose=2ml). Follow up Injection will be given at 2 weeks interval for total of 6 sessions (at 0,2, 4, 6,8,10 weeks) Post treatment follow up: at 12 weeks.

Drug: 5-Fluorouracil

Group B: Intralesional triamcinolone acetonide and 5-fluorouracil (5-FU) combination

EXPERIMENTAL

Group B: 1 ml of 40 mg/ml triamcinolone acetonide will be mixed with 1ml of 50 mg/ml FU. Injection Method: Five units (0.125ml) of the mixture will be given intralesional with the help of 1ml insulin syringe of 40units, that covers an area of about 0.5X0.5 cm2 of scar, each extra area of 0.5x0.5cm2 will be given 5 units of injection of above mixture of drugs. (maximum dose 2ml). Follow up Injection will be given at 2 weeks interval for total of 6 sessions (at 0,2, 4, 6,8,10 weeks), Post treatment follow up: at 12 weeks.

Drug: 5-Fluorouracil

Interventions

5-Fluorouracil DRUG

Group A: 1ml of 40mg/ml triamcinolone acetonide will be mixed with 1ml of normal saline Group B:1 ml of 40 mg/ml triamcinolone acetonide will be mixed with 1ml of 50 mg/ml FU Five units (0.125ml) of the mixture TAC 40mg/ml and 5-FU 50mg/ml (1:1) i.e. 2.5mg TAC and 3.125mg of 5-FU or TAC 40mg/ml and 2%xylocaine (1:1) i.e. 2.5mg of TAC will be given intralesional with the help of 1ml insulin syringe of 40units, that covers an area of about 0.5X0.5 cm2 of scar, thus, a scar of 1 cm2 will require 4 injections to cover the whole lesion. Each extra area of 0.5x0.5cm2 will be given 5 units of injection of above mixture of drugs. For the larger lesions, dose can be increased but no more than 2ml in each group. Injection will be given at 2 weeks interval for total of 6 sessions (at 0,2, 4, 6,8,10 weeks) Post treatment follow up: at 12 weeks.

Also known as: Triamcinolone acetonide

Group A: Intralesional (IL) triamcinolone acetonide (TAC) alone;; Group B: Intralesional triamcinolone acetonide and 5-fluorouracil (5-FU) combination

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with clinically diagnosed keloid or hypertrophic scar
• Size of scar 1cm in length or more
• Informed consent given

You may not qualify if:

• Under treatment of keloids or hypertrophic scar in past 6 months
• Patient with renal disease
• Patient with liver disease
• History of Hypersensitivity to 5-fluorouracil or triamcinolone acetonide
• Immunosuppressed conditions: HIV, Immunosuppressive therapy, Uncontrolled diabetes
• Pregnant or lactating women or patient planning for pregnancy
• Open wound in the scar
• Atrophic scar
• Patients suffering from chronic infectious conditions like Tuberculosis
• Patients with low WBC count

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead
• Nepal Health Research Council: collaborator

Study Sites (1)

B.P. Koirala Institute of Health Sciences

Dharān, Province No. 1, 025, Nepal

Location

MeSH Terms

Conditions

Keloid

Interventions

Fluorouracil; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ripala Acharya, MBBS

  B.P. Koirala Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This study will be double blinded with both the participants (keloid/hypertrophic scar patient fulfilling all the criteria)) and trial investigator (treatment provider) being blinded. The participants will be unaware of the treatment group that they will be allocated. And even the investigator performing the procedure and assessing the scar in each visit will be unaware of the drugs that will be given. The independent dermatologist, which will have the sealed envelope will open the envelope and instruct the trained nurse to prepare the mixture of drugs as the group written in the envelope and provide it to the blinded investigator after removing the label on the mixture of drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior resident

Model Details: Randomized, Parallel Group, Double Blinded, Clinical Trial Group A: Will receive Intralesional Triamcinolone acetonide only Group B: Will receive Intralesional Triamcinolone acetonide + 5 fluorouracil combination

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 23, 2021
• Study Start: January 28, 2021
• Primary Completion: August 14, 2021
• Study Completion: September 14, 2021
• Last Updated: April 7, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)