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4.
J Eur Acad Dermatol Venereol ; 30(5): 829-36, 2016 May.
Article in English | MEDLINE | ID: mdl-26691278

ABSTRACT

BACKGROUND: There are a limited number of approved treatments for papulopustular rosacea (PPR) and remission is difficult to maintain after successful treatment. OBJECTIVES: To investigate remission over a 36-week extension period in patients with moderate to severe PPR successfully treated with 16 weeks' treatment with ivermectin 1% cream once daily (QD) or metronidazole 0.75% cream twice daily (BID) in a randomized, parallel-group Phase III study. METHODS: Treatment was discontinued in patients initially successfully treated [Investigator's Global Assessment (IGA) score of 0 or 1] with ivermectin 1% cream QD (n = 399) or metronidazole 0.75% cream BID (n = 365; Part A) and patients were followed every 4 weeks for up to 36 weeks (Part B). Treatment with the same study treatment as used in Part A was only re-initiated if patients relapsed (IGA ≥ 2). Efficacy assessments were: time to first relapse; relapse rate; and number of days free of treatment. Safety assessments included incidence of adverse events and local cutaneous signs and symptoms. RESULTS: The median time to first relapse was significantly longer (115 days vs. 85 days) and relapse rates at the end of the study period significantly lower (62.7% vs. 68.4%) for patients initially successfully treated with ivermectin 1% compared with metronidazole 0.75%; Kaplan-Meier plot demonstrated a statistically significant difference between the two arms (P = 0.0365). The median number of days free of treatment was higher for ivermectin compared with metronidazole (196 days vs. 169.5 days; P = 0.026). The percentage of patients who experienced a related adverse event was equally low in both groups. CONCLUSION: The results of this relapse study showed that an initial successful treatment with ivermectin 1% cream QD significantly extended remission of rosacea compared with initial treatment with metronidazole 0.75% cream BID following treatment cessation.


Subject(s)
Ivermectin/administration & dosage , Metronidazole/administration & dosage , Remission Induction , Rosacea/drug therapy , Humans , Rosacea/physiopathology
5.
Br J Dermatol ; 172(4): 1103-10, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25228137

ABSTRACT

BACKGROUND: Few therapeutic alternatives currently exist in the treatment of papulopustular rosacea (PPR). OBJECTIVES: To demonstrate superiority of once-daily ivermectin 1% cream (IVM 1%) once daily vs. twice-daily metronidazole (MTZ 0·75%) cream, regarding percentage reduction of inflammatory lesions in subjects with moderate to severe PPR. METHODS: In this Phase 3, investigator-blinded, randomized, parallel-group study, subjects received IVM 1% once daily, or MTZ 0·75% twice daily over 16 weeks. Efficacy assessments were inflammatory lesion counts and Investigator's Global Assessment (IGA). Safety assessments included incidence of adverse events (AEs) and local tolerance parameters. Subjects evaluated their disease following a 5-grade scale and completed questionnaires. RESULTS: A total of 962 subjects were randomized to receive IVM 1% (n = 478) or MTZ 0·75% (n = 484). At week 16, IVM 1% was significantly superior to MTZ 0·75% in terms of reduction from baseline in inflammatory lesions (83·0% vs. 73·7%; P < 0.001), observed as early as week 3 (Last Observation Carried Forward, LOCF). IGA results (subjects 'clear' or 'almost clear') also favoured IVM 1%: 84·9% vs. 75·4%, respectively (P < 0.001). Incidence of AEs was comparable between groups and local tolerability was better for IVM 1%. More subjects receiving IVM rated their global improvement as 'excellent' or 'good.' CONCLUSIONS: Ivermectin 1% cream was significantly superior to MTZ 0·75% cream and achieved high patient satisfaction.


Subject(s)
Dermatologic Agents/administration & dosage , Ivermectin/administration & dosage , Metronidazole/administration & dosage , Rosacea/drug therapy , Administration, Cutaneous , Adolescent , Adult , Aged , Aged, 80 and over , Dermatologic Agents/adverse effects , Female , Humans , Ivermectin/adverse effects , Male , Metronidazole/adverse effects , Middle Aged , Ointments , Patient Satisfaction , Treatment Outcome , Young Adult
6.
J Eur Acad Dermatol Venereol ; 25(9): 1108-11, 2011 Sep.
Article in English | MEDLINE | ID: mdl-21812829

ABSTRACT

BACKGROUND: Cutaneous warts are common and caused by a number of different types of human papillomaviruses (HPVs). OBJECTIVE: The aim of this study was to investigate the HPV types causing common warts and to determine any association between the HPV type and the duration of warts and response to cryotherapy. METHODS: Eighty wart samples from 76 immunocompetent patients were taken from warts by paring prior to cryotherapy and analysed by in situ hybridization (ISH) with HPV probes specific to HPV 1, 2, 3, 4, 7, 10 and 57 and PCR analysis using degenerate cutaneous HPV primers with subsequent DNA sequencing. Each patient's details, including site, duration and response of the wart to cryotherapy were recorded. Cryotherapy was performed at 2 week intervals for a maximum of 12 weeks. RESULTS: An HPV type was identified in 65 samples. The majority of warts (58 samples) were typed as HPV 2/27/57 by ISH and/or PCR. Three of the 18 samples that were HPV negative with ISH were HPV positive by PCR. Response to treatment did not correlate with HPV type, duration or location. In the 21 wart parings taken from patients aged 16 and under, response to treatment did not correlate with HPV type but warts of shorter duration were more likely to resolve with cryotherapy treatment than longer standing lesions. CONCLUSION: This study demonstrates that HPV type can be determined from wart parings. HPV-2 related viruses are the prevalent HPV types causing common warts on the hands and feet in this population.


Subject(s)
Cryotherapy , Papillomaviridae/classification , Warts/therapy , Warts/virology , Adolescent , Adult , Aged , Child , Child, Preschool , Female , Humans , In Situ Hybridization , Male , Middle Aged , Papillomaviridae/isolation & purification , Polymerase Chain Reaction
7.
Br J Dermatol ; 161(6): 1365-70, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19681862

ABSTRACT

BACKGROUND: In a recent open pilot trial, R-salbutamol sulphate, a well-known molecule with anti-inflammatory effects, was tested successfully on patients with therapy-resistant discoid lupus erythematosus (DLE). OBJECTIVES: To compare the efficacy and safety of R-salbutamol cream 0.5% vs. placebo on DLE lesions in a multicentre, double-blinded, randomized, placebo-controlled phase II trial. METHODS: Thirty-seven patients with at least one newly developed DLE lesion were randomized - 19 to the R-salbutamol cream 0.5% and 18 to placebo - and treated twice daily for 8 weeks. Efficacy was evaluated through scores of erythema, scaling/hypertrophy and induration as well as pain and itching; general improvement scored by the investigator and global improvement scored by patients' assessment were also evaluated. RESULTS: The mean area under the curve of improvement for scaling/hypertrophy, pain, itching and global patient assessment was significantly better for the actively treated patients as compared with placebo (scaling/hypertrophy, P = 0.0262; pain, P = 0.0238; itching, P = 0.0135; global patient assessment, P = 0.045). Moreover, the percentage of patients without induration was significantly higher in the active group compared with the placebo group (P = 0.013), and a statistically significantly greater decrease in the size of the lesional area was also seen in the overall analysis of the R-salbutamol-treated patients (P = 0.0197). No serious adverse events were reported. CONCLUSIONS: Application of R-salbutamol cream 0.5% was safe and well tolerated. Statistically significant effects were seen on scaling/hypertrophy, induration, pain and itching as well as patient global assessment, suggesting that R-salbutamol could be a promising new topical therapy alternative for DLE.


Subject(s)
Albuterol/therapeutic use , Lupus Erythematosus, Discoid/drug therapy , Pruritus/drug therapy , Administration, Topical , Adult , Aged , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Lupus Erythematosus, Discoid/psychology , Male , Middle Aged , Patient Satisfaction , Pruritus/psychology , Skin Absorption , Stereoisomerism , Treatment Outcome
8.
Br J Dermatol ; 159(4): 942-51, 2008 Sep.
Article in English | MEDLINE | ID: mdl-18637898

ABSTRACT

BACKGROUND: For the treatment of a chronic disease like atopic dermatitis, sustained tolerability and efficacy of the applied medication are essential. OBJECTIVES: The present open-label, noncomparative study was conducted to obtain information on the long-term safety and efficacy of 0.1% tacrolimus ointment. METHODS: Patients aged 2 years or older with an affected body surface area of more than 5%, who previously participated in a clinical trial on tacrolimus ointment, were eligible for this study. The treatment area was defined by the investigator at study entry. Both children and adults applied continuously or intermittently 0.1% tacrolimus ointment twice daily during episodes of active disease plus an additional week after remission over a follow-up period of up to 4 years. RESULTS: The intent-to-treat population comprised 782 patients, with a median age of 22 years (range 2-72). Patients remained in the study for up to 4 years. Approximately half of the patients discontinued the study prematurely; the median follow-up was 1422 days. Median tacrolimus ointment use was 31.2 g during the first week; ointment use decreased during the first year and then remained stable for the remainder of the study. The median cumulative tacrolimus use was 271.5 g at month 6, 462.5 g at month 12, 739.9 g at month 24, 1029.3 g at month 36 and 1320.8 g at month 48. Altogether 51.8% of patients discontinued the study prematurely; the main reasons were withdrawal of consent (13.3%), loss to follow-up (11.3%) and lack of efficacy (9.4%). Adverse events led to study discontinuation in 3.7% of the patients. The most frequent application site events were skin burning and pruritus. These events were most often reported in adult patients during the initial treatment period; prevalence decreased after the first week and remained at a low level throughout the study. Nonapplication site events occurred with stable incidences throughout the study period. In general, calculated daily hazard rates did not indicate an increased risk of adverse events with prolonged treatment. The total affected body surface area decreased substantially upon onset of treatment and efficacy of treatment was maintained until the end of the study with smaller but continuous improvements throughout the follow-up period. Overall, 75% of the patients and 76% of the investigators rated their satisfaction with the treatment as excellent, very good or good at the end of the study or at the time of premature discontinuation. CONCLUSIONS: The safety profile of intermittent or continuous long-term application of 0.1% tacrolimus ointment for up to 4 years was consistent with that which has been established from shorter studies and gave no reason for concern. In addition, 0.1% tacrolimus ointment demonstrated sustained efficacy as reflected by the expression of high satisfaction with treatment by both patients and investigators.


Subject(s)
Dermatitis, Atopic/drug therapy , Immunosuppressive Agents/administration & dosage , Tacrolimus/administration & dosage , Adolescent , Adult , Aged , Child , Child, Preschool , Follow-Up Studies , Humans , Immunosuppressive Agents/therapeutic use , Middle Aged , Ointments , Statistics as Topic , Time Factors
9.
J Eur Acad Dermatol Venereol ; 22(11): 1343-5, 2008 Nov.
Article in English | MEDLINE | ID: mdl-18554227

ABSTRACT

Disseminated superficial actinic porokeratosis (DSAP) is the most common of the of five clinical variants of porokeratosis. These are disorders of keratinization and the distinctive pathological feature is the cornoid lamella at the margin. DSAP usually manifests in the third or fourth decades of life with a female preponderance and with multiple lesions over sun-exposed areas. A diverse range of treatments is employed though evidence of efficacy remains largely anecdotal. We report a series of eight patients with DSAP treated with 3% diclofenac gel (Solaraze gel).


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Diclofenac/therapeutic use , Keratosis, Actinic/drug therapy , Administration, Topical , Aged , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Diclofenac/administration & dosage , Female , Gels , Humans , Male , Middle Aged
10.
Br J Dermatol ; 159(2): 407-12, 2008 Aug.
Article in English | MEDLINE | ID: mdl-18565187

ABSTRACT

BACKGROUND: There is a perceived need for a better method for clinical assessment of the severity of psoriasis vulgaris. The most frequently used system is the Psoriasis Area and Severity Index (PASI), which has significant disadvantages, including the requirement for assessment of the percentage of skin affected, an inability to separate milder cases, and a lack of linearity. The Copenhagen Psoriasis Severity Index (CoPSI) is a novel approach which comprises assessment of three signs: erythema, plaque thickness and scaling, each on a four-point scale (0, none; 1, mild; 2, moderate; 3, severe), at each of 10 sites: face, scalp, upper limbs (excluding hands and wrists), hands and wrists, chest and abdomen, back, buttocks and sacral area, genitalia, lower limbs (excluding feet and ankles), feet and ankles. OBJECTIVES: To evaluate the inter-rater and intrarater reliability of the CoPSI and to provide comparative data from the PASI and a Physician's Global Assessment (PGA) used in recent clinical trials on psoriasis vulgaris. METHODS: On the day before the study, 14 dermatologists (raters) with an interest in psoriasis participated in a detailed training session and discussion (2.5 h) on use of the scales. On the study day, each rater evaluated 16 adults with chronic plaque psoriasis in the morning and again in the afternoon. Raters were randomly assigned to assess subjects using the scales in a specific sequence, either PGA, CoPSI, PASI or PGA, PASI, CoPSI. Each rater used one sequence in the morning and the other in the afternoon. The primary endpoint was the inter-rater and intrarater reliability as determined by intraclass correlation coefficients (ICCs). RESULTS: All three scales demonstrated 'substantial' (a priori defined as ICC > 80%) intrarater reliability. The inter-rater reliability for each of the CoPSI and PASI was also 'substantial' and for the PGA was 'moderate' (ICC 61%). The CoPSI was better at distinguishing between milder cases. CONCLUSIONS: The CoPSI and the PASI both provided reproducible psoriasis severity assessments. In terms of both intrarater and inter-rater reliability values, the CoPSI and the PASI are superior to the PGA. The CoPSI may overcome several of the problems associated with the PASI. In particular, the CoPSI avoids the need to estimate a percentage of skin involved, is able to separate milder cases where the PASI lacks sensitivity, and is also more linear and simpler. The CoPSI also incorporates more meaningful weighting of different anatomical areas.


Subject(s)
Psoriasis/diagnosis , Severity of Illness Index , Adult , Aged , Chronic Disease , Female , Humans , Male , Middle Aged , Observer Variation , Psoriasis/pathology , Reproducibility of Results
11.
Br J Dermatol ; 158(4): 808-17, 2008 Apr.
Article in English | MEDLINE | ID: mdl-18294310

ABSTRACT

BACKGROUND: Patients with severe chronic hand eczema (CHE) refractory to topical corticosteroids currently have limited treatment options suited for chronic use, and few controlled clinical studies have investigated new therapies in this setting. OBJECTIVES: To assess the efficacy and safety of oral alitretinoin (9-cis retinoic acid) taken at 10 mg or 30 mg once daily for up to 24 weeks, compared with placebo control, in the treatment of severe CHE refractory to topical corticosteroids. METHODS: A randomized, double-blind, placebo-controlled, prospective, multicentre trial was conducted in 111 dermatology outpatient clinics in Europe and Canada. A total of 1032 patients with severe refractory CHE were randomized in a 1 : 2 : 2 ratio to placebo, or 10 mg or 30 mg of oral alitretinoin once daily for up to 24 weeks. Safety was assessed for all patients during a follow-up period of 4 weeks, and responders were observed for relapse for 24 weeks after the end of therapy. The primary efficacy parameter was Physician Global Assessment of overall CHE severity, with response defined as clear or almost clear hands. RESULTS: Responses, defined as clear or almost clear hands, were achieved in up to 48% of patients treated with alitretinoin, compared with 17% for placebo (P < 0.001), with up to 75% median reduction in disease signs and symptoms. Treatment was well tolerated, with dose-dependent adverse effects comprising headache, mucocutaneous events, hyperlipidaemia, and decreased free thyroxine and thyroid-stimulating hormone. The median time to relapse, defined as recurrence of 75% of initial signs and symptoms, was 5.5-6.2 months in the absence of anti-eczema medication. CONCLUSIONS: Alitretinoin given at well-tolerated doses induced clearing of CHE in a substantial proportion of patients with severe disease refractory to standard therapy.


Subject(s)
Dermatologic Agents/administration & dosage , Eczema/drug therapy , Hand Dermatoses/drug therapy , Tretinoin/analogs & derivatives , Adolescent , Adult , Aged , Alitretinoin , Chronic Disease , Dermatologic Agents/adverse effects , Dose-Response Relationship, Drug , Drug Administration Routes , Epidemiologic Methods , Female , Humans , Male , Middle Aged , Tretinoin/administration & dosage , Tretinoin/adverse effects
12.
Clin Exp Allergy ; 37(10): 1536-40, 2007 Oct.
Article in English | MEDLINE | ID: mdl-17850382

ABSTRACT

BACKGROUND: Montelukast is an antagonist of cys-leukotriene receptors used mainly in the treatment of asthma- and seasonal-allergic rhinitis. Initial reports concerning the use of montelukast in atopic dermatitis (AD) have been encouraging, although not consistent. OBJECTIVES: We have undertaken a randomized, double-blind, parallel-group, placebo-controlled trial to investigate further the efficacy of montelukast in the treatment of atopic eczema. METHODS: Following a screening visit, subjects received placebo treatment for 2 weeks in a single-blind phase, followed after visit 2 by an 8-week, double-blind period of treatment with montelukast 10 mg daily or placebo. Subjects were patients aged 16-60 years under our care for treatment of AD of moderate severity, defined by a six-area, six-sign atopic dermatitis (SASSAD) score in the range 12-50. Response to treatment was assessed by investigators and by subjects using a seven-point scale, with response defined as marked improvement or better. In addition, the SASSAD score was used to monitor the severity of clinical signs. The proportion of skin involved was estimated and visual analogue scales were used to record the severity of pruritus and sleep disturbance. Topical corticosteroid usage was recorded using a five-point scale. Adverse events were recorded. RESULTS: Sixty subjects were recruited and 54 completed the study. The treatment groups were well matched for disease severity at baseline (SASSAD scores were 25 and 29 in the montelukast and placebo groups, respectively). There were no significant differences between the treatment groups in any of the parameters used to assess treatment response. The improvement in mean SASSAD score from baseline (visit 2) to the end of treatment was marginally superior in the placebo group, 1.41 points on montelukast vs. 1.76 on placebo, a difference of 0.35 (95% confidence interval -6.1 to 6.8). Adverse events were generally of a mild nature except for a brief septicaemic illness in one subject receiving montelukast. CONCLUSIONS: The data do not support previous reports of efficacy of montelukast in treatment of AD.


Subject(s)
Acetates/therapeutic use , Dermatitis, Atopic/drug therapy , Leukotriene Antagonists/therapeutic use , Quinolines/therapeutic use , Acetates/adverse effects , Adolescent , Adult , Cyclopropanes , Double-Blind Method , Female , Humans , Leukotriene Antagonists/adverse effects , Male , Middle Aged , Placebos , Quinolines/adverse effects , Sulfides , Treatment Outcome
13.
J Eur Acad Dermatol Venereol ; 21(9): 1151-60, 2007 Oct.
Article in English | MEDLINE | ID: mdl-17894698

ABSTRACT

The scalp is the most common site of disease involvement at the onset and throughout the course of psoriasis. For many patients, psoriasis of the scalp is the most difficult aspect of their disease; yet, despite a wide range of therapy options and an extensive literature base, scalp psoriasis remains difficult to treat, highlighting a long-standing unmet need for the effective treatment of scalp psoriasis. A review of past and current medical literature reveals that a number of interesting therapeutic approaches have been used in the treatment of scalp psoriasis. The diverse and sometimes extreme therapeutic approaches, the marginal benefit of many topical agents, the paucity of controlled studies evaluating the efficacy of topical agents in the treatment of scalp psoriasis and the high level of patient dissatisfaction with currently available treatments for psoriasis all support the need for new, effective and well-tolerated treatment options for scalp psoriasis.


Subject(s)
Psoriasis/drug therapy , Scalp , Administration, Topical , Adrenal Cortex Hormones/therapeutic use , Cholecalciferol/analogs & derivatives , Cholecalciferol/therapeutic use , Humans , Phototherapy , Psoriasis/diagnosis , Psoriasis/radiotherapy , Quality of Life , X-Ray Therapy , X-Rays
14.
Clin Exp Allergy ; 36(9): 1115-21, 2006 Sep.
Article in English | MEDLINE | ID: mdl-16961710

ABSTRACT

BACKGROUND: The hygiene hypothesis is often proposed to explain the high prevalence of atopy in the western world. Dysregulation of the immune system may result from inadequate exposure to micro-organisms such as mycobacteria. A small trial suggested that a killed extract of Mycobacterium vaccae ameliorates atopic dermatitis (AD). OBJECTIVES: To confirm in a large clinical trial whether killed M. vaccae ameliorates AD in 5-16-year-old children. METHODS: This was a randomized, placebo-controlled, double-blind, multi-centre study of the effect of intradermal injection of killed M. vaccae (0.1 or 1 mg) on patients, aged 5-16, with moderate-to-severe AD. Patients were followed up for 24 weeks. The primary end point was the change in severity of AD at 12 weeks, assessed using the six area, six-sign, atopic dermatitis (SASSAD) score. Secondary end points included changes in disease extent, patient's global assessment and children's dermatology life quality index. RESULTS: There were 166 patients randomized. The mean SASSAD score fell to a similar degree at week 12 in all treatment arms: from 33 to 24, (26%) in the high-dose group, from 30 to 23 (25%) in the low-dose group and from 36 to 27 (24%) in the placebo group (P>0.05). Secondary end points followed the same trend. Adverse events were generally those expected to occur in this population. Injection site reactions occurred in 32 patients at week 4. CONCLUSIONS: M. vaccae was no more effective than the placebo in ameliorating the severity of AD.


Subject(s)
Bacterial Vaccines/immunology , Dermatitis, Atopic/immunology , Mycobacterium/immunology , Adolescent , Bacterial Vaccines/administration & dosage , Bacterial Vaccines/adverse effects , Child , Child, Preschool , Dermatitis, Atopic/therapy , Double-Blind Method , Drug Administration Schedule , Eczema/drug therapy , Eczema/immunology , Female , Humans , Injections, Intradermal/adverse effects , Male , Severity of Illness Index , Treatment Outcome
15.
Br J Dermatol ; 155(4): 707-13, 2006 Oct.
Article in English | MEDLINE | ID: mdl-16965419

ABSTRACT

BACKGROUND: There is a lack of consensus as to the best way of monitoring psoriasis severity in clinical trials. The Psoriasis Area and Severity Index (PASI) is the most frequently used system and the Physician's Global Assessment (PGA) is also often used. However, both instruments have some drawbacks and neither has been fully evaluated in terms of 'validity' and 'reliability' as a psoriasis rating scale. The Lattice System Physician's Global Assessment (LS-PGA) scale has recently been developed to address some disadvantages of the PASI and PGA. OBJECTIVES: To evaluate the inter-rater and intrarater reliability of the PASI, PGA and LS-PGA. METHODS: On the day before the study, 14 dermatologists (raters), with varied experience of assessing psoriasis, received detailed training (2.5 h) on use of the scales. On the study day, each rater evaluated 16 adults with chronic plaque psoriasis in the morning and again in the afternoon. Raters were randomly assigned to assess subjects using the scales in a specific sequence, either PGA, LS-PGA, PASI or PGA, PASI, LS-PGA. Each rater used one sequence in the morning and the other in the afternoon. The primary endpoint was the inter-rater and intrarater reliability as determined by intraclass correlation coefficients (ICCs). RESULTS: All three scales demonstrated 'substantial' (a priori defined as ICC > 80%) intrarater reliability. The inter-rater reliability for each of the PASI and LS-PGA was also 'substantial' and for the PGA was 'moderate' (ICC 75%). CONCLUSIONS: Each one of the three scales provided reproducible psoriasis severity assessments. In terms of both intrarater and inter-rater reliability values, the three scales can be ranked from highest to lowest as follows: PASI, LS-PGA and PGA.


Subject(s)
Psoriasis/pathology , Severity of Illness Index , Adult , Aged , Chronic Disease , Female , Humans , Male , Middle Aged , Observer Variation , Reproducibility of Results
16.
Br J Dermatol ; 154(6): 1169-74, 2006 Jun.
Article in English | MEDLINE | ID: mdl-16704650

ABSTRACT

BACKGROUND: The value of folate supplementation in methotrexate (MTX)-treated patients remains controversial. OBJECTIVES: To determine the effect of folic acid (FA) on the efficacy of MTX and the frequency of side-effects associated with MTX therapy. METHODS: A 12-week double-blind clinical trial was conducted in patients with psoriasis stable on their long-term MTX doses but not receiving FA. They were randomized into two arms of either FA 5 mg or placebo daily. MTX doses were not changed throughout the study. Patients were monitored every 3 weeks by the same observer. Assessments included Psoriasis Area and Severity Index (PASI), a visual analogue scale (VAS) of patients' perception of their psoriasis severity and the Dermatology Life Quality Index (DLQI). Adverse events were systematically recorded. Haematological and biochemical monitoring was performed. RESULTS: Twenty-two patients with psoriasis were recruited. Age, sex and weekly MTX doses were similar in both groups. All 22 patients completed the study. The mean PASI in the FA group increased from 6.4 at baseline to 10.8 at 12 weeks. In the placebo group the mean PASI fell from 9.8 at baseline to 9.2 at 12 weeks. The mean change from baseline in the FA group was 4.4 vs. -0.6 in the placebo group (P < 0.05). Similar trends were observed in the changes in VAS and in the DLQI and differences between the groups were significant for both these parameters (P < 0.05). Few adverse effects were reported. CONCLUSIONS: This study suggests that supplementation with FA during long-term MTX treatment reduces the efficacy of MTX in the control of psoriasis. Due to the relatively small sample size and short duration of this study, no conclusions can be drawn regarding the possibility that FA may reduce the side-effects of MTX.


Subject(s)
Dermatologic Agents/therapeutic use , Folic Acid/therapeutic use , Methotrexate/therapeutic use , Psoriasis/drug therapy , Adult , Aged , Aged, 80 and over , Dermatologic Agents/adverse effects , Dermatologic Agents/antagonists & inhibitors , Double-Blind Method , Drug Therapy, Combination , Female , Humans , Male , Methotrexate/adverse effects , Methotrexate/antagonists & inhibitors , Middle Aged , Patient Compliance , Quality of Life , Severity of Illness Index , Treatment Outcome
17.
Clin Exp Dermatol ; 30(1): 14-6, 2005 Jan.
Article in English | MEDLINE | ID: mdl-15663493

ABSTRACT

The inflammation which follows cryotherapy is a significant disadvantage of this therapeutic modality. To date, the only treatment shown to reduce this inflammation is application of topical corticoids. We have therefore conducted a pilot study to investigate whether pretreatment with the free radical scavengers, vitamins C and E might alleviate the signs and symptoms of inflammation following liquid nitrogen cryotherapy of common warts. We undertook a randomized, double-blind, placebo-controlled, parallel group study. We recruited 40 adult patients, of whom 38 returned for evaluation. Treatments comprised vitamin C (2000 mg) and vitamin E (800 IU) daily or matching placebo for 7 days prior to cryotherapy to a hand wart. Oedema volume, erythema level, pain intensity and the presence or absence of blistering were assessed 24 h after cryotherapy. There were no significant differences between the two treatment groups in any of the parameters assessed. This study yielded no suggestion of benefit from the use of pretreatment with free radical scavengers in conjunction with liquid nitrogen cryotherapy.


Subject(s)
Ascorbic Acid/administration & dosage , Cryotherapy/adverse effects , Dermatitis/prevention & control , Vitamin E/administration & dosage , Adolescent , Adult , Aged , Blister/etiology , Dermatitis/etiology , Double-Blind Method , Edema/etiology , Erythema/etiology , Female , Humans , Male , Middle Aged , Pain, Postoperative/etiology , Pilot Projects , Warts/therapy
18.
Br J Dermatol ; 151 Suppl 70 Dec 2004: 3-27, 2004 Dec.
Article in English | MEDLINE | ID: mdl-15548171

ABSTRACT

For more than five decades, topical corticosteroids and emollients have been the mainstay of therapy for atopic dermatitis. However, the potential for side-effects limits the clinical utility of corticosteroids in providing long-term disease control. With a unique mode of action that differs from that of corticosteroids, the steroid-free topical calcineurin inhibitors (TCIs), tacrolimus ointment and pimecrolimus cream, provide skin-selective treatment that targets key factors involved in the pathogenesis of this chronic disease. An extensive series of clinical trials involving more than 16,000 patients with predominantly moderate to severe atopic dermatitis in tacrolimus studies and over 2000 patients with primarily mild to moderate disease in pimecrolimus studies has shown that both TCIs provide effective and well-tolerated treatment for atopic dermatitis. Randomized controlled trials have demonstrated that tacrolimus is superior to conventional hydrocortisone-based regimens and does not cause skin atrophy or other steroidal side-effects. Both tacrolimus and pimecrolimus prevent disease flares and provide progressive and sustained disease improvement with long-term therapy. These and other clinical benefits of TCIs are discussed, together with the safety profiles of tacrolimus and pimecrolimus and their use in clinical practice. In addition, this review summarizes findings from the many trials carried out with these agents and outlines how TCIs can provide long-term treatment and control of a chronic skin disease that may persist for years.


Subject(s)
Calcineurin Inhibitors , Dermatitis, Atopic/drug therapy , Dermatologic Agents/administration & dosage , Immunosuppressive Agents/administration & dosage , Tacrolimus/analogs & derivatives , Tacrolimus/administration & dosage , Administration, Topical , Adrenal Cortex Hormones/administration & dosage , Clinical Trials as Topic , Cost-Benefit Analysis , Dermatologic Agents/adverse effects , Dermatologic Agents/chemistry , Drug Therapy, Combination , Humans , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/chemistry , Ointments , Patient Selection , Tacrolimus/adverse effects , Tacrolimus/chemistry , Treatment Outcome
19.
Br J Dermatol ; 150(4): 741-6, 2004 Apr.
Article in English | MEDLINE | ID: mdl-15099371

ABSTRACT

BACKGROUND: Fumaric acid esters (FAE) are used as a systemic treatment for severe psoriasis in Germany but there has been only very little published experience from the U.K. The potential for use in combination with other systemic drugs has not been explored. OBJECTIVES: To present data relating to the efficacy of FAE in severe psoriasis and to examine the potential dose-sparing effect and safety issues when FAE are combined with other systemic agents. METHODS: We retrospectively analysed the records of patients who had received FAE for severe psoriasis either alone (in two cases) or along with other systemic medications (in 10 cases). We reviewed the efficacy of FAE and assessed whether dose reductions were achieved for other systemic drugs. Patients were monitored carefully for possible adverse effects. RESULTS: Of 12 patients treated with FAE one discontinued the drug very early, due to flushing, while on a very low dose. The other 11 patients all demonstrated an improvement in psoriasis after starting FAE. Nine patients received FAE in combination with other systemic therapies including ciclosporin, acitretin, hydroxyurea and methotrexate. Seven achieved useful overall reductions in the dose of the other drugs. In two patients severe psoriasis was controlled using FAE alone. The side-effect profile of FAE was similar to that previously reported. There was no evidence of drug interactions. CONCLUSIONS: FAE appear effective and less toxic than other systemic treatments for psoriasis. FAE were used successfully in combination with other systemic agents and generally enabled the doses of the more hazardous drugs to be reduced. Extremely careful monitoring is required when using FAE in such combined regimens as experience is currently very limited.


Subject(s)
Dermatologic Agents/therapeutic use , Fumarates/therapeutic use , Psoriasis/drug therapy , Adult , Aged , Cyclosporine/adverse effects , Cyclosporine/therapeutic use , Dermatologic Agents/adverse effects , Drug Interactions , Drug Therapy, Combination , Esters , Female , Flushing/chemically induced , Fumarates/adverse effects , Humans , Male , Middle Aged , Retrospective Studies , Time Factors , Treatment Outcome
20.
Hosp Med ; 65(2): 100-2, 2004 Feb.
Article in English | MEDLINE | ID: mdl-14997777

ABSTRACT

Erythroderma is a life-threatening state of skin failure. This dermatological emergency often presents to an acute medical unit or accident and emergency department. Effective initial management is vital.


Subject(s)
Dermatitis, Exfoliative , Acute Disease , Dermatitis, Exfoliative/etiology , Dermatitis, Exfoliative/therapy , Emergencies , Female , Humans , Male , Prognosis
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