BACKGROUND:Topical calcipotriol is a vitamin D3 analogue which influences keratinocyte proliferation and differentiation. Its efficacy in cutaneous lichen planus has not been well evaluated. METHODS: This is a randomized open-label trial comparing the effectiveness of calcipotriol 50 microg/g versus betamethasone 0.1% ointments twice daily for 12 weeks in patients with cutaneous lichen planus, with respect to thickness, pigmentation, clearance and pruritus. Patient self-assessment was made at 0, 4, 8 and 12 weeks post randomization using visual analogue scales (VAS). Clinical assessment was made at week 12 and adverse events noted. Clinical response was defined as 75% or more for lesion flattening and absent or minimal pigmentation, and 50% or more for clearance. RESULTS: A total of 31 patients were randomized: 15 to calcipotriol and 16 tobetamethasone. Clinically assessed lesion flattening occurred in approximately half the patients. With calcipotriol, there were two responses for pigmentation and one for clearance but none with betamethasone. Patient VAS indicated a gradual improvement in all measures but with little difference between the treatments. The largest difference indicated a 12-point disadvantage to calcipotriol for thickness but this was not statistically significant (p=0.09). Side effects reported were erythema (one patient) and increased pruritus (two patients), all with calcipotriol. CONCLUSION: Calcipotriol appears no more effective than betamethasone. The course of the disease appears to be affected in the same way by both treatments.
RCT Entities:
BACKGROUND: Topical calcipotriol is a vitamin D3 analogue which influences keratinocyte proliferation and differentiation. Its efficacy in cutaneous lichen planus has not been well evaluated. METHODS: This is a randomized open-label trial comparing the effectiveness of calcipotriol 50 microg/g versus betamethasone 0.1% ointments twice daily for 12 weeks in patients with cutaneous lichen planus, with respect to thickness, pigmentation, clearance and pruritus. Patient self-assessment was made at 0, 4, 8 and 12 weeks post randomization using visual analogue scales (VAS). Clinical assessment was made at week 12 and adverse events noted. Clinical response was defined as 75% or more for lesion flattening and absent or minimal pigmentation, and 50% or more for clearance. RESULTS: A total of 31 patients were randomized: 15 to calcipotriol and 16 to betamethasone. Clinically assessed lesion flattening occurred in approximately half the patients. With calcipotriol, there were two responses for pigmentation and one for clearance but none with betamethasone. Patient VAS indicated a gradual improvement in all measures but with little difference between the treatments. The largest difference indicated a 12-point disadvantage to calcipotriol for thickness but this was not statistically significant (p=0.09). Side effects reported were erythema (one patient) and increased pruritus (two patients), all with calcipotriol. CONCLUSION:Calcipotriol appears no more effective than betamethasone. The course of the disease appears to be affected in the same way by both treatments.