Calcipotriol Ointment Research Articles

A new topically applied liquor carbonis distillate (coal tar) solution helps reduce regression of plaque psoriasis after 12 weeks of treatment: A 6-week comparison to calcipotriol cream

A new topically applied liquor carbonis distillate (coal tar) solution helps reduce regression of plaque psoriasis after 12 weeks of treatment: A 6-week comparison to calcipotriol cream

Treatment of Nail Psoriasis with a Two-Compound Formulation of Calcipotriol plus Betamethasone Dipropionate Ointment

Background: Treatment of nail psoriasis remains a challenge. Objective: To evaluate the efficacy of a two-compound product of calcipotriol plus betamethasone dipropionate ointment on nail psoriasis in an open-label study. Methods: Twenty-five psoriatic patients with nail involvement and mild cutaneous psoriasis were instructed to apply a calcipotriol-betamethasone valerate ointment formulation once daily for 12 weeks on affected nails. Outcome measures were assessed at baseline and at weeks 4, 8 and 12 using the nail psoriasis severity index (NAPSI). Results: Twenty-two patients having 114 nails involved at baseline with a mean NAPSI of 5.8 ± 1.7 were followed up for 12 weeks. The mean NAPSI at the end of the treatment period was reduced to 1.6 ± 0.6 presenting a 72% improvement. Significant improvement was observed for hyperkeratosis and onycholysis (reduction of mean hyperkeratosis NAPSI from 2.2 ± 0.5 to 0.5 ± 0.1 and mean onycholysis NAPSI from 2.0 ± 0.6 to 0.4 ± 0.2), moderate improvement for oil drops (reduction of mean oil drop NAPSI from 1.2 ± 0.4 to 0.8 ± 0.3) and slight improvement for pitting (reduction of mean pitting NAPSI from 0.8 ± 0.2 to 0.6 ± 0.2). Conclusions: The calcipotriol plus betamethasone dipropionate two-compound ointment, applied once daily for 12 weeks, was shown to improve nail psoriasis.

Itch in psoriasis: epidemiology, clinical aspects and treatment options.

Pruritus is an important symptom in psoriasis vulgaris, may be severe and seriously affect the quality of life of patients, but published data on its frequency and characteristics are limited. The study objective was to characterize the prevalence of itch in psoriatic patients and the effect of treatment modalities by using a comprehensive itch questionnaire of own design. A structured itch questionnaire was given to 90 patients with moderate to severe chronic-plaque psoriasis selected consecutively from the patients visiting the Department of Dermatology of the University of Florence. The questionnaire concerned the areas involved psoriasis and pruritus, the pruritus characteristics, the worsening and relieving factors and treatment modalities. Itch intensity was reflected by a 10 point visual analog scale (VAS) and the degree of symptoms discriminated between mild (1-3), moderate (4-7) and severe (8-10). Almost 85% of psoriatic patients suffered from itching; the frequency of pruritus was daily and mean intensity by VAS scale was moderate. Presence and intensity of pruritus and body mass index (BMI) were correlated. 40% of patients with pruritus were overweight (BMI > 25 < 30) and 10% obese (BMI > 30). Almost all patients appeared unsatisfied with the available treatment modalities for pruritus in psoriasis. Emollients, topical steroids and calcipotriol cream could relieve pruritus but their effect was temporary. Among the antipsoriatic therapies, phototherapy with narrow band ultraviolet B (nb-UVB) was the most effective treatment in reducing pruritus. Biological therapies, mainly etanercept and efalizumab, proved useful in its control. The questionnaire was a useful tool to characterize itch, and the results might help us to better understand pruritus in psoriasis. The results confirmed the need for a global study of psoriasis with regard to both the cutaneous manifestations and the itch symptom.

Easy to diagnose, difficult to treat: keratosis lichenoides chronica

Keratosis lichenoides chronica (KLC) is a rare disease, with approximately 70 cases reported in the literature. The problem in this long-lasting disease is generally the treatment, not the diagnosis. In the literature, many treatments failed to show any beneficial effect. We present a 20-year-old man with KLC that was successfully treated with a combination of phototherapy, acitretin and calcipotriol ointment. The patient's lesions showed a marked improvement with this combination. To our knowledge, this is the first report of this type of combination treatment being used successfully in KLC. This approach might help reduce doses of retinoids or psoralen ultraviolet A required when these are used separately, and limit the potential toxicity of these treatments.

Effect of Calcipotriol on Etanercept Partial Responder Psoriasis Vulgaris and Psoriatic Arthritis Patients

Patients who respond only partially to etanercept may require additional treatments that act synergistically to improve their therapeutic response while at the same time reducing the dose required and the risk of side-effects. The aim of this study was to evaluate the effecti veness of topical calcipotriol in etanercept partial responder patients. We enrolled 120 patients affected by psoriasis vulgaris and psoriatic arthritis. A 50 mg dose of etanercept was administered twice weekly for the first 12 weeks, followed by a 25 mg dose twice weekly for an additional 12 weeks. At week 12, for 45 patients who had not achieved PASI 50, calcipotriol cream was also prescribed twice daily for 4 weeks and then once daily for a further 8 weeks. At week 24, of the 45 patients in the group treated with etanercept plus calcipotriol, 14 (31.1%) had achieved PASI 75, and 23 PASI 50, while 8 (17.7%) had dropped out of therapy; of the 75 patients who continued etanercept in monotherapy with a 25 mg dose twice weekly for another 12 weeks, 71 (94.6%) had achieved PASI 50 and 57 (76.0%) PASI 75. The application of calcipotriol in etanercept partial responder patients had therefore helped 37 out of 120 patients (31%) achieve at least PASI 50. This is the first report about the controlled combination of topical calcipotriol and etanercept in a large group of psoriatic patients. The efficacy and cost-effectiveness of the combined treatment is evidenced by the good response shown at week 24 by a group of etanercept low-responder patients using drugs sparingly and limiting likely toxicity.

Two therapeutic challenges: facial vitiligo successfully treated with 1% pimecrolimus cream and 0.005% calcipotriol cream

Two therapeutic challenges: facial vitiligo successfully treated with 1% pimecrolimus cream and 0.005% calcipotriol cream

Topical calcipotriol as monotherapy and in combination with psoralen plus ultraviolet A in the treatment of vitiligo

Background Recent advances in the pathophysiology of vitiligo have demonstrated defective calcium homeostasis in depigmented skin. 1,25-Dihydroxyvitamin D3 may be involved in the regulation of melanin synthesis, and receptors for 1,25-dihydroxyvitamin D3 have been demonstrated on melanocytes. Objectives We conducted an open study to determine the efficacy and tolerability of calcipotriol cream as monotherapy and in conjunction with psoralen plus ultraviolet A (PUVA) in the treatment of vitiligo. Methods Twenty-six patients with vitiligo affecting 5–40% of their skin were recruited. Twenty-two were treated with twice-daily topical calcipotriol monotherapy (50 µg g−1) and four were placed on combination treatment with twice-daily topical calcipotriol 50 µg g−1 in conjunction with topical or oral 8-methoxypsoralen PUVA three times weekly. Results Treatment was well tolerated at all sites and no adverse effects were reported. After a therapy time of 3–9 months (mean 6 months), 77% (17 of 22) of those treated with monotherapy showed 30–100% improvement, and three of the four patients on combination treatment showed good response. Conclusions Topical calcipotriol appears to be an effective and well-tolerated treatment for vitiligo and can be safely used in conjunction with PUVA, but controlled studies are necessary to exclude the possibility of spontaneous repigmentation.

Targeted and combination treatments for vitiligo Comparative evaluation of different current modalities in 458 subjects

The current treatment of vitiligo is not satisfactory according to the opinions of both the patient population and the dermatologists. Recently, combination therapies have been introduced, which are both systemic and targeted (microphototherapy). To evaluate the effects of topical treatments given alone or in combination with 311-nm narrow-band microphototherapy. We evaluated the efficacy and safety of: (1) 311-nm narrow-band microphototherapy;(2) tacrolimus 0.1% ointment twice a day; (3) pimecrolimus 1% cream twice a day; (4) betamethasone dipropionate 0.05% cream twice a day; (5) calcipotriol ointment 50 microg/g twice a day; and (6) 10%l-phenylalanine cream twice a day, for the treatment of exclusively vitiligo patches. A 311-nm narrow-band microphototherapy (Bioskin) was given alone or in combination with the above-mentioned popular local treatments. Four hundred and seventy patients suffering from vitiligo that affected less than 10% of the skin surface were evaluated. The patients were divided into 11 groups according to the selected treatment modalities. Four hundred and fifty-eight patients completed the study period of 6 months. Excellent repigmentation (> 75%) was achieved by 72% of the patients in group 1, 76.5% in group 2, 76.1% in group 3, 90.2% in group 4, 75.6% in group 5, 74.8% in group 6, 61% in group 7, 54.6% in group 8, 71.2% in group 9, 59.1% in group 10, and 29.3% in group 11. Marked repigmentation (50-75%) was evident in 19.8% of the patients in group 1, 18.2% in group 2, 20.1% in group 3, 6.7% in group 4, 14.1% in group 5, 11.3% in group 6, 16.1% in group 7, 18.4% in group 8, 25% in group 9, 10.6% in group 10, and 8.1% in group 11. Moderate results (25-50% repigmentation) were seen in 4.6% of the patients in group 1, 3.3% in group 2, 2.7% in group 3, 2.2% in group 4, 7.4% in group 5, 10.1% in group 6, 18.4% in group 7, 21.7% in group 8, 2.1% in group 9, 27.1% in group 10, and 55% in group 11. Finally, minimal (< 25%) or no response was achieved in 3.6% of the patients in group 1, 2% in group 2, 1.1% in group 3, 0.9% in group 4, 2.9% in group 5, 3.8% in group 6, 4.5% in group 7, 5.3% in group 8, 1.75% in group 9, 3.2% in group 10, and 7.6% in group 11. Side effects were skin atrophy (76% in group 4 and 81% in group 9), stinging and burning (groups 2, 3, 7, and 8). Targeted combination therapies in vitiligo are remarkably more effective than single treatments. When single treatments are considered alone, 311-nm narrow-band UVB microfocused phototherapy and 0.05% betamethasone dipropionate cream are the most effective treatments in our study. When combined therapies are chosen, 0.05% betamethasone dipropionate cream plus 311-nm narrow-band UVB microfocused phototherapy apparently give the highest repigmentation rate. In the short term, the only side-effects registered have been cutaneous atrophy with corticosteroid cream, and stinging and burning with 0.1% tacrolimus ointment and, less frequently, with 1% pimecrolimus cream.

308nm excimer laser phototherapy of psoriasis: Monotherapy versus combination with Calcipotriol therapy

Abstract Objective Aim of the present investigation was to prove whether a combination therapy using 308 nm excimer laser phototherapy and topical Calcipotriol application is more effective than a monotherapy to treat stable plaque psoriasis. Material and methods In a one center open trial, 36 patients (21 men, 15 women) with stable, moderate to severe, plaque-type psoriasis vulgaris received 308 nm UVB dose of 200–1200 mJ/cm 2 to affected areas, delivered by an 308 nm XTRAC™ XeCl excimer laser (PhotoMedex, Radnor, PA, USA). One side of either, back, leg or arm was additionally treated with Calcipotriol ointment twice daily, starting 0–7 days before the treatment with the 308 nm laser. The other side was treated with the 308 nm laser and Vaseline only. To evaluate the efficiency of both therapy concepts, a modified Psoriasis Area and Severity Index (PASI) score was calculated, which was initially found to be 31 per side on average. Results Clearing of infiltration, erythema and scales was achieved at 25% after 2 sessions for the excimer laser treated side without Calcipotriol, and 40% in the Calcipotriol plus excimer laser treated side. Discussion With the 308 nm excimer laser (FDA approved), higher doses of UVB can be administered to the psoriatic plaques while sparing the non-affected skin. Plaques clear faster in fewer sessions at a lower cumulative dose. The combination of 308 nm excimer laser phototherapy with Calcipotriol improves the reduction of infiltration and scales of psoriatic plaques considerably. Compared to narrow-band UVB monotherapy, the narrow-band UVB plus Calcipotriol treatment needed fewer sessions of excimer laser treatment, fewer days to achieve a reduction of the PASI parameter and a lower cumulative dosage.

Videodermoscopy of the hyponychium in nail bed psoriasis

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Topical treatment of mild to moderate plaque psoriasis with 0·3% tacrolimus gel and 0·5% tacrolimus cream: the effect on SUM score, epidermal proliferation, keratinization, T-cell subsets and HLA-DR expression

Tacrolimus gel 0.3% and tacrolimus cream 0.5% were studied and compared with calcipotriol ointment 0.005%, as topical treatment for mild to moderate plaque psoriasis. Tacrolimus is able to inhibit several cellular processes thought to be important in the pathogenesis of psoriasis, e.g. the transcription of proinflammatory cytokines, keratinocyte hyperproliferation and the expression of HLA-DR in lesional psoriatic skin. In the present study we investigated the effects of preparations of tacrolimus and calcipotriol ointment on SUM score, hyperproliferation (Ki67-positive keratinocytes), keratinization (percentage keratin 10 (K10)-positive epidermal surface), T-cell subsets (CD4, CD8, CD45RO, CD45RA, CD2, CD25), cells expressing natural killer receptors and HLA-DR expression. The following three topical treatments were studied in chronic plaque psoriasis over a 12-week treatment period: calcipotriol ointment 0.005% twice daily, tacrolimus gel 0.3% twice daily and tacrolimus cream 0.5% twice daily. The mean reductions in SUM score between day 0 and week 12 for calcipotriol ointment, tacrolimus gel and cream were significant. Calcipotriol ointment, and tacrolimus gel and cream had a comparable effect on epidermal proliferation (Ki67-positive cells), but calcipotriol is significantly more effective in normalizing differentiation (K10-positive epidermal surface). Calcipotriol and tacrolimus gel both reduced several lesional T-cell subsets significantly, whereas the effect induced by tacrolimus cream was modest. Calcipotriol and tacrolimus gel are comparable in reducing the SUM score, the number of Ki67-positive cells and T-cell subsets and HLA-DR expression, although calcipotriol induces a more substantial improvement of keratinization.

The effect of alefacept on T‐cell subsets and cells expressing NK receptors in lesional psoriatic skin: The effects of monotherapy and combination treatment with calcipotriol

Objectives: To investigate the effect of weekly alefacept monotherapy 15 mg i.m. on epidermal hyperproliferation, keratinization, T‐cell subsets and cells expressing NK receptors during 12 weeks of treatment. Furthermore, the addition of calcipotriol cream to alefacept treatment was studied and compared with alefacept monotherapy. Methods: Five patients participated in this study, and used weekly alefacept 15 mg i.m. combined with calcipotriol cream up to a maximum of 100 g per week. Biopsies from two lesions (one treated and another lesion not treated with calcipotriol cream) were taken at week 0 and week 12. We investigated the number of T‐cell subsets (CD4, CD8, CD45RO, CD45RA, CD2, CD25), cells expressing NK receptors (CD94 and CD161), the proliferation marker Ki‐67 and the keratinization marker keratin‐10. Results: Alefacept monotherapy induced a statistically significant reduction of CD4+, CD45RO+ and CD2+ cells in dermis and epidermis and CD8+ cells in epidermis at week 12. Furthermore, the keratin‐10 positive epidermal surface was significantly increased at week 12. The combination of alefacept and calcipotriol cream induced a statistically significant reduction of only CD4+ and CD45RO+ cells at week 12. Conclusions: The number of memory effector T‐cells in the psoriatic lesion is significantly decreased by alefacept, and calcipotriol cream does not seem to have an additional effect on this reduction. Cells expressing NK receptors are virtually not targeted by alefacept monotherapy or the combination.

Comparative study of calcipotriol (0.005%) ointment and tazarotene (0.05% and 0.1%) gel in the treatment of stable plaque psoriasis

Topical therapies are the first line of treatment for patients with stable plaque psoriasis affecting a limited body surface area. Though in use for more than a decade, we could not find any reports of studies directly comparing calcipotriol and tazarotene. To evaluate the comparative efficacy and tolerability of calcipotriol and tazarotene in the treatment of stable plaque psoriasis. This was a prospective, right-left side intra-individual parallel 8-week study using calcipotriol 0.005% ointment applied twice daily (right side) versus tazarotene (left side) randomized to either 0.05% (group I) or 0.1% gel (group II) once daily in two groups, each of 10 patients. Efficacy was determined by the assessment of target psoriatic lesions under evaluation by using the severity scale (0-3) of erythema, scaling, and infiltration (ESI score). Evaluation was done at baseline (0 week), 4 weeks, and 8 weeks of treatment. At the end of 8 weeks, patients with more than 75% reduction in ESI score were considered to have marked improvement; 51% to 75%, moderate improvement; 26% to 50%, minimal improvement; and less than 25%, non-responders. Seventeen patients (9 in group I, 8 in group II) completed the study. In group I, reduction in ESI score was significantly more at both 4 and 8 weeks on sides treated with calcipotriol, producing moderate-to-marked improvement (P<0.05). In group II, improvement was comparable in lesions treated with either calcipotriol or tazarotene (0.1%) at the end of 4 and 8 weeks. Adverse effects noted were mild--in the form of burning, pruritus, and irritation--and were observed more often in the lesions treated with tazarotene as compared to those in the lesions treated with calcipotriol, but the difference was not statistically significant. However, none of the patients discontinued the therapy because of adverse events. Topical calcipotriol 0.005% ointment is more effective than tazarotene 0.05% gel; however, its efficacy is comparable to tazarotene 0.1% gel in the treatment of stable plaque psoriasis.

A comparison of twice-daily calcipotriol ointment with once-daily short-contact dithranol cream therapy: quality-of-life outcomes of a randomized controlled trial of supervised treatment of psoriasis in a day-care setting

Calcipotriol ointment and short-contact dithranol cream therapy are well-established topical treatments for psoriasis. Quality of life, i.e. the physical, psychological, and social functioning and well-being of the patient, has become an essential outcome measure in chronic skin disease. To compare the quality-of-life outcomes of calcipotriol ointment with that of short-contact dithranol cream in a supervised treatment regimen, and to determine the degree of improvement in quality of life these topical treatments can accomplish. In a multicentre randomized controlled trial in six centres in the Netherlands, 106 patients with chronic plaque psoriasis were included, 54 receiving calcipotriol ointment twice daily and 52 dithranol cream once daily in a 12-week intensive treatment programme. Patients were treated at the day-care centre, using the care instruction principle of daily visits during the first week and twice-weekly visits subsequently for up to 12 weeks. Quality of life was assessed with the Skindex-29 and the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36). At the end of treatment, no statistically significant differences were found between the calcipotriol and the dithranol group in any of the quality-of-life domains or scales of the Skindex-29 and the SF-36. Over time, a significant improvement of quality of life was found on all three scales of the dermatology-specific Skindex-29, predominantly of a moderate magnitude. In the calcipotriol group, a significant change of a small magnitude was found in the Physical Component Summary of the SF-36. No significant changes were found in the Mental Component Summary (or on any of the eight scales composing the questionnaire) of the SF-36. The hypothesis was confirmed, that no statistically significant differences in improvement of quality of life could be found between calcipotriol ointment and dithranol short-contact cream in a day-care setting. Given this result, both calcipotriol and dithranol can be welcome alternatives for the patient. Calcipotriol, being more practical and patient friendly, can be considered as a first-line approach in clinical practice. However, in patients recalcitrant to calcipotriol and/or other topical treatments, preference should be given to the dithranol regimen. Topical treatment in combination with interventions explicitly focusing on improvement of coping behaviour and psychosocial functioning may further increase the degree of improvement in the psychosocial domains of quality of life. The results of this study are likely to give further evidence to the notion that the generic SF-36 is little or not responsive to small to moderate changes in quality of life in mild to moderate psoriasis.

Lichen striatus following solarium exposure

Two cases of lichen striatus occurring after solarium exposure are presented. Both patients were adult females who regularly attended a solarium prior to the development of their skin lesions. A 19-year-old woman attended the solarium twice weekly for 8 weeks prior to the appearance of lichen striatus on the chest and epigastrium. The condition resolved completely with the twice daily application of calcipotriol ointment for 6 months. The second patient, a 40-year-old woman, attended the solarium once weekly for 3 months before lichen striatus developed on the abdomen. She was treated with clobetasol propionate ointment, calcipotriol ointment and intralesional triamcinolone acetonide and the eruption cleared 7 months after onset. The histopathological picture in both patients supported a diagnosis of lichen striatus.

Apoptosis, P53 and Bcl‐2 expression in response to topical calcipotriol therapy for psoriasis

The histopathologic changes characteristic of psoriasis might be related to suppressed apoptosis. The P53 and Bcl-2 proteins play a central role in the regulation of apoptosis. This study aimed to evaluate P53 and Bcl-2 expression and apoptotic cells in the psoriatic skin before and after topical calcipotriol therapy. Skin biopsies were obtained from nonlesional and lesional skin of 10 patients with generalized plaque psoriasis before and after treatment with topical calcipotriol ointment. The P53 and Bcl-2 expression was evaluated using immunoperoxidase technique and apoptotic cells by the terminal deoxynucleotide transferase (TdT) mediated deoxyuridine triphosphate nick end labeling (TUNEL) method. After topical calcipotriol therapy, keratinocytes of psoriatic skin showed significant decrease of P53 (P = 0.002) and increase of Bcl-2 (P = 0.01) expression. On the other hand lymphocytes showed significant decrease of Bcl-2 (P = 0.01). There were no apoptotic cells before treatment but after calcipotriol therapy, apoptosis was more detectable in keratinocytes than in lymphocytes. The results of the study suggested that one of the actions of calcipotriol in psoriasis might be exerted through induction of apoptosis, especially of keratinocytes, through a P53-independent pathway. Meanwhile, suppression of Bcl-2 expression in lymphocytes may promote apoptosis of dermal lymphocytes leading to healing of psoriasis.

Circumscribed acral hypokeratosis

Circumscribed acral hypokeratosis (CAH) is an idiopathic condition that typically presents as an acquired, solitary, asymptomatic, well-defined, depressed, flat-based deformity, with a slightly raised border on the palm or, rarely, the sole. Histologically, the lesional epidermis is depressed with a characteristic, abrupt, hyperkeratotic, slightly-raised ridge at the transition from normal skin. We sought to present 3 additional cases of CAH. A review of 3 cases of CAH was performed. Liquid phase polymerase chain reaction (PCR) was conducted to evaluate for human papillomavirus (HPV). Three cases of CAH were reviewed. One patient had a history of a burn at the site prior to developing the disorder while another patient, as a child, had a history of verruca plantaris in the same location. Lesions were solitary, involving the palm or sole, in 2 cases and in one case they were multiple involving both the palms and the soles. HPV testing detected HPV type 6 in the lesion of one patient who previously was treated for warts in the same location. Topical fluorouracil, calcipotriol ointment under occlusion, and clobetasol ointment under occlusion were unsuccessful in one patient. In case 2, we were pathology consultants and unable to evaluate the clinical appearance of the lesion. CAH may involve palms and/or soles. Lesions may be solitary or multiple, and vary widely in size. We believe that CAH most likely represents a reaction pattern developing in response to various stimuli, including trauma, HPV, or both.

Smoothing the mosaic subclinical melanoderma by calcipotriol

The observation of photo-exposed skin under ultraviolet light reveals a mosaic pattern of varying intensity in epidermal melanization. Several patterns of mosaic subclinical melanoderma (MSM) have been described using a specially designed CCD camera and the ultraviolet light-enhanced visualization (ULEV) method. Vitamin D(3) and its analogues influence the biology of keratinocytes and melanocytes. To assess the effect of calcipotriol on MSM. This randomized split-face study was conducted in 27 men to compare the effect of once daily applications of 5% calcipotriol cream or a moisturizing cream on the heterogeneity of facial MSM. Computerized image analysis of video images was used at 1-month intervals before and during a 2-month treatment, as well as during a 3-month follow-up. At both sites, the average melanin content of the epidermis showed no significant change over time. However, the mottled appearance was smoothened at the calcipotriol site, whereas it was increased at the site receiving the moisturizer. The decreased heterogeneity in MSM after calcipotriol applications suggests a control of the epidermal melanocyte unit by the vitamin D(3) derivative.

An investigator‐masked comparison of the efficacy and safety of twice daily applications of calcitriol 3 µg/g ointment vs. calcipotriol 50 µg/g ointment in subjects with mild to moderate chronic plaque‐type psoriasis

Calcitriol and calcipotriol, two vitamin D derivatives, are available for topical treatment of psoriasis and have been shown to be effective. To compare the efficacy and safety of calcitriol 3 microg/g and calcipotriol 50 microg/g. This was a multicentre, randomized, investigator-masked, and parallel comparison in subjects with mild to moderate chronic plaque-type psoriasis receiving either calcitriol or calcipotriol ointment twice daily for 12 weeks. Efficacy evaluations comprised global improvement (on a 4-point scale from 0: no change or worse, to 3: clear or almost clear) assessed by the investigator and by the subject. Efficacy further included the 'dermatological sum score' at each study visit. Safety evaluations included adverse event reporting, cutaneous safety assessed by the investigator and cutaneous discomfort assessment by the subject (both on a 5-point scale from 0: none, to 4: very severe). A total of 250 subjects of both gender were recruited. At week 12, the LSmean score of global improvement rated by the investigator was 2.27 for calcitriol and 2.22 for calcipotriol. This difference was not statistically significant, with calcitriol demonstrating to be non-inferior to calcipotriol for global improvement. This same parameter was scored by the subject, with a mean of 2.12 for calcitriol and 2.09 for calcipotriol. The percentage of patients with at least marked improvement tended to be in favour of calcitriol (95.7% vs. 85% for calcipotriol). However, differences were not statistically significant. The mean worst score for the cutaneous safety assessment was higher in the calcipotriol group (0.3 vs. 0.1 and 0.4 vs. 0.2, by the investigator and the patient, respectively). These differences were statistically significant in favour of a better safety profile for calcitriol (P=0.0035). Fourteen dermatological and treatment-related adverse events were reported with calcipotriol vs. only five with calcitriol for a total of 22 adverse events reported throughout the study. Calcitriol administered twice daily over a 12-week treatment period demonstrated similar efficacy to calcipotriol, while showing a significantly better safety profile.

Combination of 308‐nm xenon chloride excimer laser and topical calcipotriol in vitiligo

A large variety of therapeutic agents are being used for the treatment of vitiligo, but treatment remains a challenge. Recently, monochromatic phototherapies such as 311-nm narrowband ultraviolet B therapy and 308-nm xenon chloride excimer laser have been reported to be an effective and safe therapeutic option in children and adult patients with vitiligo. Single reports stipulate that the addition of topically applied calcipotriol to phototherapy increases its effectiveness. The purpose of the present pilot study was to determine if the addition of topical calcipotriol increases the efficacy of the 308-nm xenon chloride excimer in the treatment of vitiligo. Ten patients with vitiligo with essentially bilateral symmetrical lesions were enrolled in this prospective right/left comparative, single-blinded trial conducted over a 15-month period. All patients received 308-nm XeCl excimer laser therapy three times weekly. Calcipotriol ointment (Daivonex) was applied to lesions on one side of the body twice daily. After 24 treatments (8 weeks), nine patients were evaluated. Eight patients showed evidence of repigmentation on both body sides, with no significant difference between the body side treated with calcipotriol and excimer laser and the side treated with excimer laser alone. The mean repigmentation rate was 22.4% (1-37%). The addition of calcipotriol ointment to 308-nm xenon chloride excimer laser phototherapy does not significantly enhance its efficacy. Small additive effects must be investigated in a larger trial.