Assessment of Dose Related Response of Intra-lesional Triamcinolone Acetonide in the Treatment of Keloid Scars at Kenyatta National Hospital: a Clinic Based Randomized Control Study

Abstract

Background: Keloids are benign dermal fibro-proliferative disorders that arise as a result of trauma or infection that surpasses the margins of the original lesion. The lesions continue to enlarge over time, pain and itching are the predominant symptoms in these patients. The scars have a high relapse rate after surgical removal and thus alternative non-operative measures are recommended for the primary keloid treatment. Triamcinolone acetonide injection is a first line treatment in the management of this condition and is usually administered through the intra-lesional route. This will ameliorate the symptoms and, in some instances, can lead to remission of the keloid scars. However, there is no agreed dosage per cm2, duration and frequency of treatment amongst different surgeons. This leaves the patient at the mercy of the surgeon’s discretion despite the triamcinolone acetate (TAC) having adverse effects especially if administered in very high dosages. These effects range from abnormally hypo-pigmentation, subcutaneous fat atrophy, telangiectasia, tissue necrosis, ulcerations and cushingoid habitus. Keloids are common in African and Asian communities with very low incidences reported amongst the Caucasians. Objective: To determine safe, effective dosage of triamcinolone acetate in the management of keloids in African population. Methodology: This was a randomized control study where patients presenting with keloids at The Kenyatta National Hospital were randomly assigned into three groups each having a minimum of 25 patients. The study arms had either 5mg/cm2 or 10mg/cm2 intra-lesional TAC injection while the control group had 7.5 mg/cm2 of TAC administered. The frequency of treatment was a single dose every four weeks for a total of 12 weeks making a total of 3 injections per keloid scar. Treatment outcomes and adverse effects were noted and documented 30 days after each injection. The data were cleaned and uploaded to the SPSS version 21 software for analysis. A p≤ 0.05 indicates the rejection of the null hypothesis. Results: A total of 34 patients who presented with 109 keloids were recruited into the study. Fifty three point eight percent (53.8%) were female and 43.6% were males. Seventy eight point one percent (78.1%) of the study participants were between 18 -40 years, 7.3% between 41-60 years while 9.1% were above 61 years. A decrease in height and surface area of the keloid was noted in all 3 arms of the study. The greatest decrease of height was 2.055 cm (46.58%) seen in the 7.5mg/ml arm followed by 5mg/ml and 10mg/ml arms which recorded a decrease of 1.87 cm xiii (56.55%) and 1.649cm (49.92%) respectively. The greatest margin reduction in scar size was seen in the 5 mg/ml arm at 2.54 cm2 followed by 10mg/ml and 7.5mg/ml which had a decrease of 2.16 cm2and 1.81 cm2 respectively. The 10mg/ml dosage had the highest decrease of pain at 100% followed by 7.5 mg/ml at 96.98 % and 5mg/ml at 96.80%. There was also a decrease in itchiness of the keloids with the highest decrease seen in the 7.5mg/ml arm at 95.95% followed by 5mg/ml and 10mg/ml arms that had symptomatic decreases of 94.56% and 92.31% respectively. There was a 20.46% (Poor) reduction in the mean VSS score on Day 30, 35.62% (Good) reduction by Day 60 and 52.95% (Very Good) reduction by Day 90 of the study after 3 injections sessions of TAC. Adverse effects of TAC occurred across the 3 arms of the study. Under the 5mg/ml arm, 7.69% of the patients had scar ulceration and 2.56% had scar hypo pigmentation occurring. Eight point thirty three percent (8.33%) of the patients under the 7.5mg/ml arm reported scar ulceration with that reporting scar hypo pigmentation being at 2.78%. The study participants were, generally satisfied with the outcome, with the average rating of their satisfaction at 1.79 on a scale of 1 – 10. Majority of the patients who were most satisfied reported the disappearance of pain, pruritus and softness of the scars as their most improved aspects of their scars. Conclusion: All the 3-dosage concentration in the study showed improvement in the symptoms, had similar morphological changes and comparable patient satisfaction scores.