The Effect of Combined Calcipotriol and Betamethasone Dipropionate Ointment in the Treatment of Vitiligo: An Open, Uncontrolled Trial
October 2012 | Volume 11 | Issue 10 | Original Article | 52 | Copyright © October 2012
Vitiligo is a frequent dyschromia characterized by achromic macules that reflect the absence of melanocytes. It affects 1% of the general population. Treatment of vitiligo is a challenge. Recently, topical calcipotriol has been claimed to be effective, either as monotherapy or as part of combination therapies.
To evaluate the efficacy and safety of calcipotriol 0.005%/betamethasone dipropionate 0.05% ointment in the treatment of vitiligo.
Thirty-one patients with vitiligo were enrolled in our study. The mean age of the patients was 32.6±11 years (range 18-56 years) and the mean duration of vitiligo was 3.7±5.8 years (range 0.07-30 years). Patients were treated with topical calcipotriol 0.005%/betamethasone dipropionate 0.05% ointment twice a day for at least 12 weeks, and the degree of repigmentation was analyzed using digital photography at baseline and at weeks 4, 8, and 12. The response was evaluated as excellent (76%-100%), moderate (51%-75%), mild (26%-50%), minimal (1%-25%), or no response. Possible adverse effects during the treatment period were also noted.
Three patients (9.7%) had an excellent response, six patients (19.4%) had a moderate response, eight patients (25.8%) had a mild response, seven patients (22.6%) had a minimal response, and seven patients (22.6%) had no response. Patients at a progressive phase responded better to this ointment than patients at a stable phase (P=.005). The correlations between response rate and the duration of the disease were not significant (P=.791). Four adverse events related to the ointment were reported (pruritus, n=2; acne, n=2).
Calcipotriene 0.005%/betamethasone dipropionate 0.05% ointment is effective and well tolerated in the treatment of patients with vitiligo.
J Drugs Dermatol.
Vitiligo is a common, idiopathic, acquired, depigmenting disease characterized by loss of normal melanin pigments in the skin. It affects 1% to 2% of the general population without sex or skin color predilection.1 Various theories such as the autoimmune, autocytotoxic, and neural hypotheses have been proposed as the possible causes. Autocytotoxic hypotheses state the presence of cytotoxic T cells targeting melanocyte antigens eventually leads to melanocyte damage and death.2 Because of the adverse effects and poor results of available treatment, therapies for vitiligo continue to be researched. Topical corticosteroids are known to be effective, but are associated with serious adverse effects such as cutaneous atrophy and telangiectasia.3,4
Calcipotriol is a synthetic, low calcemic analog of nuclear hormone 1,25 dihydroxyvitamin D3 (1,25[OH]2D3). Recently, topical calcipotriol has been used for vitiligo as monotherapy or as part of a combined therapy.5-7 The exact role of calcipotriol in melanogenesis is not yet understood. Recently, some investigators have suggested that 1,25(OH)2D3 is involved in the regulation of melanin synthesis, acting on specific T-cell activation to influence melanocyte maturation and differentiation, and also to upregulate melanogenesis.8,9 The aim of this open, comparative clinical trial was to evaluate the efficacy and safety of calcipotriene 0.005%/betamethasone dipropionate 0.05% ointment.
This study included 31 patients with a clinical diagnosis of vitiligo, recruited with informed consent from the Outpatient Clinic of the Dermatology Department in the Third People's Hospital of Hangzhou from September 2011 to December 2011. All patients were older than 18 years and had a body surface area involvement of ≤5%. Exclusion criteria included patients who had used any topical or systemic treatment or phototherapy in the four weeks before the study, pregnant or lactating women, patients with any significant systemic, psychiatric, or other dermatological conditions that might compromise the result of the study, patients who did not complete sessions or follow-up, and patients who reacted to an initial application of the ointment. Clinical features and a detailed medical history, including family history, concurrent diseases, disease duration, and previous treatments, were noted in all patients. Clinical presentations included focal, segmental, and generalized types of vitiligo. Nonsegmental types were noted as either focal or generalized types. The term "active" refers to the expansion of existing lesions or the appearance of new lesions, and "stable" refers to the condition when these symptoms are not present.