METHODS: This was a prospective, randomised, observer-blinded study. Two keloids on the same site were randomly assigned to receive either daily topical clobetasol propionate 0.05% cream under occlusion with silicone dressing (Scar 1) or monthly IL triamcinolone injection (Scar 2). Efficacy was assessed using patient and observer scar assessment scale (POSAS) at 4-weekly intervals up to 12 weeks. Dimension of keloid and adverse effects were also assessed.
RESULTS: A total of 34 scars from 17 patients completed the study. There was significant improvement of POSAS at 12 weeks compared to baseline within each treatment group. However, there was no statistically significant difference in POSAS at 12 weeks between the two treatments. Keloid dimensions showed a similar trend of improvement by week 12 with either treatment (p = 0.002 in Scar 1, p = 0.005 for Scar 2). However, there was no significant difference between the treatment. In the IL triamcinolone group, all patients reported pain and 70.6% observed necrotic skin reaction. There was a significantly higher rate of adverse effects such as erythema (41.2 vs. 17.6%), hypopigmentation (35.3 vs. 23.5%), telangiectasia (41.2 vs. 17.6%) and skin atrophy (23.5 vs. 5.9%) documented in the IL triamcinolone group when compared to clobetasol propionate 0.05% cream under occlusion with silicone dressing.
CONCLUSION: Clobetasol propionate 0.05% cream under occlusion with silicone dressing is equally effective and has fewer adverse effects compared to IL triamcinolone. Hence, it may be used as an alternative treatment for keloid particularly in patients with low pain threshold, needle phobia and those who prefers home-based treatment.
MATERIALS AND METHODS: A total of 231 OSMF patients were selected and treated with basic regime including topical corticosteroids, oral antioxidants and the icecream-stick exercise regime and allotted randomly to two equal groups A and B. Group-A patients were additionally given MED. Subgroups A1 and B1 patients with an inter-incisal distance (IID) 20-35mm were not given any additional therapy; subgroup A2 and B2 patients (IID 20-35mm) were treated additionally with intra-lesional injections. Subgroups A3 and B3 with IID<20mm were managed surgically. IID was measured at baseline and at 6 months recall. The change in IID measurements was calculated and statistically analyzed using 2-way ANOVA and Tukeys multiple post hoc analysis.
RESULTS: Average improvement in IID after six months of recall visits was observed to be 8.4 mm in subgroup-A1 (n-53) compared to 5.5 mm in B1(n-50) (p<0.01). The IID improvement in subgroup-A2 was found to be 9.3mm (n-46) compared to 5.1 mm in B2 (n-48) (p<0.01). In the surgery group, mouth opening improvement was observed to be 9.6 mm in subgroup A3 (n-18) compared to 4.8 mm for B3 (n-16) (p<0.01).
CONCLUSIONS: Use of the MED appears to be effective for increasing oral opening in OMSF patients in conjunction with local, injection and/or surgical treatment.