An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

BACKGROUND: Methotrexate is one of the most commonly used systemic drugs for the treatment of moderate to severe psoriasis; however, high-quality evidence for its use is sparse and limited to use of oral dosing. We aimed to assess the effect of an intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis. METHODS: We did this prospective, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (METOP) at 16 sites in Germany, France, the Netherlands, and the UK. Eligible patients were aged 18 years or older, had a diagnosis of chronic plaque psoriasis for at least 6 months before baseline, had currently moderate to severe disease, and were methotrexate treatment-naive. Participants were randomly assigned (3:1), via a computer-generated random number sequence integrated into an electronic data capture system, to receive either methotrexate at a starting dose of 17·5 mg/week or placebo for the first 16 weeks, followed by methotrexate treatment of all patients up to 52 weeks (methotrexate-methotrexate vs placebo-methotrexate groups). Dose escalation to 22·5 mg/week was allowed after 8 weeks of methotrexate treatment if patients had not achieved at least a 50% reduction in baseline Psoriasis Area and Severity Index score (PASI), with corresponding volume increases in placebo injections. Treatment was combined with folic acid 5 mg/week. Group allocation was concealed from participants and investigators from the time of randomisation until an interim database lock at week 16, and was open label from week 16 onwards, with no masking of participants or investigators. The primary efficacy endpoint was a 75% reduction in PASI score (PASI 75) from baseline to week 16. We did analysis by modified intention to treat, with non-responder imputation. This study is registered with EudraCT, number 2012-002716-10. FINDINGS: Between Feb 22, 2013, and May 13, 2015, we randomly assigned 120 patients to receive methotrexate (n=91) or placebo (n=29). At week 16, a PASI 75 response was achieved in 37 (41%) patients in the methotrexate group compared with three (10%) patients in the placebo group (relative risk 3·93, 95% CI 1·31-11·81; p=0·0026). Subcutaneous methotrexate was generally well tolerated; no patients died or had serious infections, malignancies, or major adverse cardiovascular events. Serious adverse events were recorded in three (3%) patients who received methotrexate for the full 52 week treatment period. INTERPRETATION: Our findings show a favourable 52 week risk-benefit profile of subcutaneous methotrexate in patients with psoriasis. The route of administration and the intensified dosing schedule should be considered when methotrexate is used in this patient group. FUNDING: Medac.

Efficacy and safety of fumaric acid esters in combination with phototherapy in patients with moderate-to-severe plaque psoriasis (FAST).

BACKGROUND: While treatment of patients with moderate-to-severe psoriasis using a combination of fumaric acid esters (FAE, Fumaderm® ) and phototherapy (UV) is common practice, there have been hardly any studies investigating this regimen. Available information is limited to data from a small pilot study. The objective of the present study was to evaluate FAE/UV combination therapy in a larger patient cohort with moderate-to-severe psoriasis. PATIENTS AND METHODS: In this prospective noninterventional multicenter study, data from patients treated with FAE/UV combination therapy was assessed with regard to efficacy (PGA' PASI, DLQI, EQ-5D), safety, and dosage over a twelve-month period. The findings were subsequently compared to data from a previous retrospective study on FAE monotherapy. RESULTS: Data from 363 patients was included in the analysis. Efficacy measures improved substantially on combination therapy. Compared to FAE monotherapy, FAE/UV therapy led to a faster clinical response, however, there was no difference in efficacy after 12 months. Neither the duration nor the type of phototherapy had an impact on efficacy. In general, combination therapy was well tolerated. Seven percent of patients experienced adverse events. CONCLUSIONS: FAE/UV combination therapy is effective and well tolerated in patients with moderate-to-severe psoriasis. Such treatment may induce a faster therapeutic response, and appears to be useful, particularly in the first three months of FAE therapy.

Wirksamkeit und Sicherheit von Fumarsäureestern in Kombination mit Phototherapie bei Patienten mit moderater bis schwerer Plaque-Psoriasis (FAST).

HINTERGRUND: Die Behandlung von Psoriasis-Patienten mit einer Kombination aus Fumarsäureestern (FSE, Fumaderm® ) und Phototherapie (UV) ist verbreitet, wurde aber im Rahmen von Studien wenig untersucht. Bisher liegen lediglich Daten aus einer kleinen Pilotstudie vor. Intention dieser Studie war, eine FSE/UV-Kombinationsbehandlung an einem größeren Patientenkollektiv mit mittelschwerer bis schwerer Psoriasis zu untersuchen. PATIENTEN UND METHODIK: In dieser prospektiven, multizentrischen, nichtinterventionellen Studie wurden Daten von Patienten mit FSE/UV-Kombinationstherapie hinsichtlich der Wirksamkeit (PGA' PASI, DLQI, EQ-5D), Sicherheit und Dosierung über einen Zeitraum von zwölf Monaten erfasst und mit Daten einer retrospektiven Studie mit FSE-Monotherapie verglichen. ERGEBNISSE: Es wurden Daten von 363 Patienten ausgewertet. Unter der Kombinationstherapie verbesserten sich alle Wirksamkeitsparameter deutlich. Im Vergleich zur Monotherapie mit FSE konnte durch die Kombination mit UV ein schnellerer Wirkeintritt erzielt werden, wobei nach zwölf Monaten kein Unterschied in der Wirksamkeit bestand. Die Dauer und Art der Phototherapie zeigte keinen Einfluss auf die Wirksamkeitsparameter. Allgemein wurde die Kombinationstherapie gut vertragen. Unerwünschte Ereignisse wurden bei 7 % der Patienten berichtet. SCHLUSSFOLGERUNGEN: Die FSE/UV Kombinationstherapie zeigt eine gute Wirksamkeit und Verträglichkeit und kann zu einem schnelleren Wirkeintritt führen. Eine Kombinationstherapie erscheint vor allem in den ersten drei Monaten der FSE Behandlung sinnvoll.

Retrospective data collection of psoriasis treatment with fumaric acid esters in children and adolescents in Germany (KIDS FUTURE study).

BACKGROUND: Given that there is no standard systemic treatment for children and adolescents with plaque psoriasis, this non-interventional, multicenter, retrospective study collected data on the efficacy and safety of long-term treatment with fumaric acid esters (FAEs) in this particular patient group. PATIENTS AND METHODS: In patients younger than 18 years of age at the start of FAE treatment, data on efficacy and safety was retrospectively collected for at least 36 months. RESULTS: Data from 127 patients (aged 6-17 years) was collected for treatment durations of up to 60 months. Physician's Global Assessment, Psoriasis Area and Severity Index, and Body Surface Area showed marked improvement in the first six months. After 36 months, these parameters had, on average, improved by up to two-thirds of baseline values. Thirty-seven patients experienced at least one adverse event (AE), which was FAE-related in 36 individuals. Three AEs (proteinuria (one case), flushing (two cases)) persisted during the observation period while on treatment. Fifteen AEs led to the discontinuation of therapy; nearly all of these cases were related to gastrointestinal disorders. CONCLUSIONS: The KIDS FUTURE study - for the first time - included a larger population of children and adolescents with psoriasis who were treated with FAEs. The data obtained suggests that long-term FAE therapy in this patient group may be effective and safe. The results are currently being verified in an ongoing clinical study.

IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study.

BACKGROUND: IncobotulinumtoxinA improves the appearance of facial rhytides and the aging neck. OBJECTIVE: To investigate the efficacy, safety, and subject satisfaction of incobotulinumtoxinA for platysmal band treatment. METHODS: Subjects (n = 23) with 2 to 4 platysmal bands (scoring ≥1 on a newly validated 5-point assessment scale) were enrolled. IncobotulinumtoxinA (15 U) was administered to each band. Assessments, using the 5-point scale, occurred at 6 posttreatment visits over 5 months. Adverse events were recorded and subjects self-assessed the appearance of their platysmal bands versus baseline. RESULTS: At maximum tension, a response (≥1-point improvement from baseline score) was observed in 65.2% of subjects 3 (±1) days posttreatment, rising to 100% on Day 8 (±1). The change from baseline in the mean score was significant at each time point, including the final visit (Weeks 20-21). Response rates were higher at maximum tension than at rest. The peak effect occurred later at rest than at maximum tension. No serious adverse event occurred. At maximum tension, 69.6%, 73.9%, and 68.2% of subjects rated their platysmal bands as "improved" or "markedly improved" at Visits 2, 3, and 4, respectively. CONCLUSION: IncobotulinumtoxinA is an effective and well-tolerated treatment for platysmal bands, with a rapid onset and long duration of effect.

Benefit evaluation in the therapy of chronic wounds from the patients' perspective--development and validation of a new method.

Assessing therapeutic benefit of any drug and medical device is essential in registration and cost reimbursement decisions in Germany and in many nations. In this study, a method for the assessment of patient-relevant benefits in wound therapy was developed and validated. A total of 83 items on treatment benefit from the patients' perspective were collected in an open survey, including n = 50 patients with chronic wounds. The item pool was compiled to a list of 22 items by an interdisciplinary panel of experts including patients. The item list is presented prior to therapy to assess patient-relevant treatment needs and during or after therapy to establish if benefits have been attained. A weighed patient benefit index (PBI) is calculated from the items of both questionnaires. The instrument was examined for practical feasibility, reliability, and validity in a prospective study involving n = 172 patients with acute or chronic wounds treated by vacuum-assisted therapy. Validation criteria were: change in generic and disease-specific quality of life; judgment of efficacy by patients and physicians; treatment satisfaction; patients' willingness to recommend the therapy to others. Construct validity was given for all criteria applied. Cronbach's alpha was 0.88. The instrument was well-accepted by patients and rated relevant for the assessment of benefit in wound treatment.

A prospective, split-face, randomized, comparative study of safety and 12-month longevity of three formulations of hyaluronic acid dermal filler for treatment of nasolabial folds.

BACKGROUND: Data regarding several hyaluronic acids (HAs) used identically for facial tissue augmentation have heretofore been unavailable. OBJECTIVES: This prospective, split-face, randomized, two-armed study sought to determine the long-term safety and effectiveness of three HAs (HA-1 (Belotero Basic/Balance), HA-2 (Restylane), and HA-3 (Juvéderm Ultra 3/Juvéderm Ultra Plus XC) in the treatment of nasolabial folds (NLFs). METHODS: Twenty participants in Arm A received HA-1 in one NLF and HA-2 in the other. In Arm B, 20 participants received HA-1 in one NLF and HA-3 in the other. Injection was at visit 2, with follow-up visits at 1, 6, 9, and 12 months. Mean volume of HA was slightly <1.5 mL/NLF. RESULTS: Adverse events were unremarkable across all HAs, with injection site erythema being the most frequent adverse event. Mean pretreatment NLF severity rating for both arms was 2.3; at 12 months, mean posttreatment severity rating was 1.5 for HA-1/HA-2 and 1.6 for HA-1/HA-3. Although not statistically significant, participants tended to show a preference for HA-1. CONCLUSION: All three HAs provided essentially equivalent results, except for 4-week evenness results, which favored HA-1. Injection volumes of the three HAs were also similar.

Comparison of two botulinum toxin type A preparations for treating crow's feet: a split-face, double-blind, proof-of-concept study.

BACKGROUND: This is the first double-blind, randomized, proof-of-concept study to compare the clinical effectiveness of botulinum toxin type A (BoNTA) free of complexing proteins with a BoNTA complex (BTXCo) in the treatment of crow's feet. PATIENTS AND METHOD: Twelve U of each product were compared in an intra-individual study in 21 participants with a facial wrinkle scale (FWS) score of 2 to 3. Evaluations were done for up to 4 months. Subjects with an improvement of at least 1 point on the FWS were considered responders. RESULTS: One month after treatment, the percentage of responders was slightly higher for the BoNTA side (95%) than the BTXCo side (90%). After 4 months, both sides still showed good efficacy, with an 84% response rate and greater than 30% FWS reduction (no statistically significant difference between the products). After 1 month, FWS score at rest was approximately 66% lower for BoNTA, versus 63% lower for BTXCo. After 4 months, FWS reduction was approximately 50%. CONCLUSION: Both botulinum toxin A products displayed high efficacy and good tolerability at a dose ratio of 1:1, with no statistically significant differences between them. The high response rates observed after 4 months suggest a good effectiveness beyond this observation period.

Quality of life evaluation in wounds: validation of the Freiburg Life Quality Assessment-wound module, a disease-specific instrument.

Many patients with chronic wounds suffer not only directly from their wounds but also from high financial, social and psychological impairments, significantly reducing their quality of life. In order to provide an instrument both applicable to different patient populations and sensitive to areas of impact specific to certain skin diseases, the modular instrument 'Freiburg Life Quality Assessment' has been developed. Each disease-specific version of the instrument consists of a core module of generic items and items specific for a distinct skin disease. Objective of the study was to assess reliability, sensitivity to change, and validity of the module for chronic ulcers. The instrument was implemented in a longitudinal observational study on vacuum-seal therapy (n = 175), in a cross-sectional observational study involving patients with chronic leg ulcers (n = 384) and in a randomised clinical trial on keratinocyte transplantation (n = 198). The instrument showed good internal consistency (Cronbach's alpha ≥0·85). There were minor floor effects ≤4·3%, but no ceiling effects. Retest-reliability and convergent validity with the EuroQol quality of life questionnaire (EQ-5D) (visual analogue scale) were satisfactory. Change scores correlated with change in other quality-of-life instruments (r = 0·59-0·61), but not with change in wound status.

Development and validation of a new instrument for the assessment of patient-defined benefit in the treatment of acne.

BACKGROUND: Benefit assessment of drugs and medical products has become a legally established feature of medical research. A standardized assessment of benefits using scientifically sound and valid methods is essential. OBJECTIVE: Development, validation and practical evaluation of an instrument to record patient benefit in treatment of acne. PATIENTS AND METHODS: In open interviews with n = 50 patients, possible benefits of the therapy from the patients' point of view were recorded. The item pool thus generated was reviewed by a panel of dermatologists, psychologists and patients and transferred to a 23-item questionnaire. This is used prior to therapy to assess patients' desired benefits and after therapy to record the perceived benefits. The therapy goals and the resulting benefits are then used to generate a weighted 'Patient Benefit Index' (PBI). The procedure has been tested for its validity and feasibility in n = 923 patients with acne. RESULTS: Patients accepted the instrument and deemed it to be easily understandable. Additionally, the method proved itself to be internally consistent, constructively valid and sensitive to changes. CONCLUSIONS: The Patient Benefit Index (PBI) is a valid and highly accepted practical instrument for recording patient benefit. The PBI permits an individualized, patient-weighted assessment of the benefits of acne therapy.

Validation of a comprehensive Freiburg Life Quality Assessment (FLQA) core questionnaire and development of a threshold system.

Health related quality of life (HRQOL) has become an important re- search topic in dermatology. We developed a series of modular, dermatology-specific HRQOL questionnaires: the Freiburg Life Quality Assessment (FLQA). Each FLQA questionnaire consists of a core module (FLQA-c) applicable to all skin diseases plus a number of items specific to distinct dermatological diseases. The objectives of the present study were: 1) to test the psychometric properties of the FLQA-c, and 2) to define a threshold indicating a significantly reduced HRQOL. 394 psoriasis patients, 253 atopic dermatitis patients, and 240 control subjects completed the FLQA-c. Cronbach's alphas were above 0.75 for all six scales except for "treatment". Discriminant validity, sensitivity to change, and convergent validity were satisfactory. On the different scales, the threshold indicating a marked reduction in HRQOL detected 33% to 68% of the patients. These data support the reliability and validity of the FLQA-c.

Experience and attitudes towards CAM--a survey of internal and psychosomatic patients in a German university hospital.

Complementary and alternative medicine (CAM) is popular in Germany. In a consecutive survey the experiences with CAM and the need for a CAM consultation among inpatients of the departments of cardiology (CL), gastroenterology (GE), oncology (OL) and psychosomatics (PS) of the University Hospital Freiburg (FUH) were questionned. Exclusion criteria were inability to understand the questions or a Karnofsky Index < 30%. Four hundred thirty-five patients were included. Three hundred and fifty patients, 100 each in the departments of CL, GE and OL, and 50 in PS answered the questionnaires. Eighty-five patients (20%) refused. Among the 350 patients 26% had previously visited a CAM physician and 19% had visited a CAM therapist (Heilpraktiker). Information about CAM was obtained mainly by television, radio and family members. Frequently used therapies for the current disease were physical training (21%), diet (19%), massage (19%), vitamins/trace elements (19%), herbs (13%), acupuncture (10%) and homeopathy (7%). The highest frequency of CAM use had PS patients, followed by GE, OL and CL patients. High effectivity (> or = 70%) for the current disease, rated on a scale of 4 degrees, had for CL patients physical exercise and massage, for GE patients herbal treatment and for OL patients diet. Physical exercise, diet, massage and herbal treatment generally had better ratings than homeopathy, acupuncture and vitamins. 65% would welcome a CAM center and 53% asked for a consultation about CAM at FUH. OL and GE patients had the strongest (58%), PS patients a lower (52%) and patients with cardiovascular diseases the lowest (43%) interest in a CAM consultation. Twenty-five percent believed, that CAM can help to cope better with their disease. Predictors for a positive attitude towards CAM were young age, aversion to chemical medications (Spearman correlation r = 0.22), desire to participate in therapeutic decisions (r = 0.29), motivation to change, if recommended, the life style (r = 0.31) and desire for a holistic treatment (r = 0.37).

Development of an adherence-enhancing intervention in topical treatment termed the topical treatment optimization program (TTOP).

Psoriasis is a common, disabling, chronic, relapsing, inflammatory disorder of the skin with a worldwide prevalence of 2-3 % in which adherence to treatment is often poor. The majority of individuals have limited disease that is being treated with topical medication according to existing guidelines. Adherence rates are lower for topical compared with systemic treatment. Low medication adherence is a major problem for patients with chronic disorders as it results in suboptimal treatment outcomes, increased risk for development of concomitant diseases, inefficient use of health resources and considerable losses to society. However, to date no adherence-enhancing intervention has been developed for psoriasis patients under topical treatment. In this article, we report the development of the topical treatment optimization program (TTOP). The TTOP intervention aims to improve the information given to the patients and to result in an engaged patient-physician relationship. Application of the TTOP intervention in daily clinical practice may lead to a significant increase of adherence and the successful management of psoriasis and other chronic skin disorders.

Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ).

Medication adherence rates strongly depend on favorable disease outcomes. It is known that medication adherence rates are lower for topical treatment than for systemic treatment. However, to date no validated instrument for the assessment of adherence factors in topical treatment is available. The aim of this study was to develop a new questionnaire to assess adherence risk factors in topical treatment. The development of the Topical Therapy Adherence Questionnaire (TTAQ) and Patient Preference Questionnaire (PPQ) was based on a systematic literature review, and qualitative patient focus interviews and expert focus groups' input. The psychometric properties and comprehensibility of the TTAQ and PPQ were assessed in a feasibility study with 59 psoriasis patients. Our first preliminary results indicate that the TTAQ and PPQ are psychometrically sound and reliable measures for the assessment of factors influencing topical treatment adherence. The questionnaires are currently being further developed and various parameters (e.g., time point of assessment) are currently being tested in an exploratory pilot study with ca. 2,000 psoriasis patients receiving topical treatment in a European clinical trial. The use of the final versions of TTAQ and PPQ in clinical practice may facilitate the early identification of specific non-adherence factors in patients under topical treatment, which could enable designing and applying adherence-enhancing interventions according to the patient's individual needs.

Onset, longevity, and patient satisfaction with incobotulinumtoxinA for the treatment of glabellar frown lines: a single-arm, prospective clinical study.

BACKGROUND: IncobotulinumtoxinA (Bocouture(®)) is free from complexing proteins and effective for treating glabellar frown lines. PURPOSE: To determine the efficacy, onset, and duration of action of incobotulinumtoxinA for the treatment of glabellar frown lines. PATIENTS AND METHODS: In this single-arm, prospective, proof-of-concept study, 23 patients were treated with 25 U incobotulinumtoxinA, equally split between five injection sites in the glabella. Severity of glabellar frown lines was rated by an independent rater from standardized photographs using the validated Merz 5-point scale at several visits over 5 months following treatment. To assess patient satisfaction, patients completed a questionnaire before and 2 weeks after treatment. RESULTS: The percentage of responders at maximum frown 2-4 days after treatment was 95.2% and 85.0% when responders were defined as patients with ≥ 1-point and ≥ 2-point improvement on the 5-point scale compared with baseline, respectively. At this time point, 84% of the maximum effect had occurred. The responder rate at maximum frown, according to both definitions, was 100% for at least the next two visits (days 8 ± 1 and 14 ± 2). At all visits, the change from baseline in the mean glabellar frown-line score at maximum frown was statistically significant, with on average an almost 1-point improvement from baseline 5 months after treatment. CONCLUSION: IncobotulinumtoxinA is an effective and well-tolerated treatment for glabellar frown lines, with a rapid onset of action and a long duration of effect lasting for more than 5 months.

Local anesthetic effects of Lidocaine cream: randomized controlled trial using a standardized prick pain.

BACKGROUND: ELA-max (4% lidocaine) and EMLA cream (lidocaine-prilocaine 2.5%) are topicals used for superficial anesthesia. Only few studies have been published on their comparative effectiveness in close-to-practice pain models. OBJECTIVE: (1) To evaluate the analgesic efficacy of lidocaine cream compared with lidocaine-prilocaine cream and placebo. (2) To assess the safety and tolerability. METHODS: Randomized, three-arm, double-blind trial in 40 healthy volunteers comparing the anesthetic effects of Lidocaine and lidocaine-prilocaine cream to placebo at various time points (0-120 min). A standardized pain was induced by lancet pricks and measured by a visual analogue scale. Intra-individual comparison between the test areas was performed in a cross-over design. RESULTS: Lidocaine showed significantly reduced pain compared to placebo at all assessment points. Pain reduction was achieved significantly earlier using lidocaine occlusively (30 min). No significant differences were found concerning the anesthetic efficacy of lidocaine and lidocaine-prilocaine cream. There were no relevant adverse events. CONCLUSION: This study confirms that a topical preparation with 4% lidocaine is an effective and safe treatment option for superficial anesthesia. It supports the claim that an occlusive application is more rapid in action. 4% lidocaine is of value as a rapidly-acting local anesthetic for the treatment of minor surgical procedures.

Prospective validation of the "rhino conjunctivitis allergy-control-SCORE©" (RC-ACS©).

BACKGROUND: Recently we reported the validation of the "Allergy-Control-SCORE© (ACS)" which assesses symptom severity as well as medication use on three dimensions lung, nose and eyes. The aim of this study was to test the validity of the score for eyes and nose. METHODS: One-hundred-twenty-one consenting subjects (age 19-65y), including 81 patients with allergic rhino-conjunctivitis (RC) and 40 healthy controls, participated in the study. Patients rated daily nasal and eye symptoms using a 4-point scale (none, mild, moderate, and severe) and their use of anti-symptomatic medication. Validation criteria were pollen counts in the course of the study period. Discrimination capacity was analyzed by comparing the rhino-conjunctivitis Allergy-Control-SCORE© (RC-ACS©) values of allergic patients and healthy controls. Convergent reliability was assessed by correlating RC-ACS© values with the global severity of allergy, the quality of life, and the allergy-related medical consultations. Retest reliability was assessed by the correlation of the repeated measured RC-ACS© scores during each of two consecutive weeks. RESULTS: Convergent reliability analysis indicated a significant correlation between RC-Allergy-Control-SCORE© and global severity of allergy (r = 0.691; p < 0.0001), quality of life (r = 0.757; p < 0.0001) and allergy-related medical consultations (r = 0.329; p = 0.0019). RC-Allergy-Control-SCORE© showed a good retest reliability (r = 0.813; p < 0.001) and discriminated extremely well between allergic patients and healthy controls (Median: 3.7 range: 0; 14.1 vs. Median: 0 range: 0; 2.9; p < 0.001), with a sensitivity of 93.8% and a specificity of 92.5% at a score value of 0.786. CONCLUSIONS: The RC-ACS© can be considered as valid and reliable to assess the severity of rhino-conjunctivitis severity in clinical trials and observational studies.

The patient benefit index: a novel approach in patient-defined outcomes measurement for skin diseases.

Evaluation of therapeutic benefits from the patient's perspective is important in medical decision-making and reimbursement. This study aimed at developing and validating an instrument on patient-defined needs and benefits in dermatology. The questionnaire was developed according to international guidelines. The benefit assessment consists of two steps: before treatment, every patient defines his treatment needs according to a standardized list. After treatment, the patient rates the degree of benefits achieved. A "patient benefit index" (PBI) is calculated by averaging the preference-weighed results of all items. The PBI questionnaire was validated in a sample of 500 patients with ten skin diseases and in a treatment study on 906 patients with acne. The patients defined a broad spectrum of needs and treatment benefits, indicating disease-specific patterns. The PBI showed good feasibility, reliability (Cronbach's alpha >0.91) and construct validity, high responsiveness, and discrimination between subgroups. The PBI permits valid evaluation of patient-relevant benefits in dermatological treatment.

Silica gel is as effective as acyclovir cream in patients with recurrent herpes labialis: results of a randomized, open-label trial.

OBJECTIVE: To compare silica gel with acyclovir cream in the treatment of recurrent herpes labialis. METHODS: In this randomized, open-label, comparator-controlled trial, 74 patients with recurrent herpes labialis applied silica gel or acyclovir cream respectively over a period of 10 days. The treatment started within 24 hours of the first symptoms of a new recurrence. Patients rated five symptoms (tautness, tingling, itching, burning sensation, pain), lesion stage, efficacy, tolerability, and duration until the onset of improvement. Their willingness-to-pay was assessed. Physicians rated the severity of the herpes recurrence and efficacy. RESULTS: There was no significant difference between silica gel and acyclovir cream in the overall patients' assessment. There is evidence that silica gel relieved all investigated symptoms earlier than acyclovir cream. The efficacy and tolerability of both medications were rated as good to very good. CONCLUSIONS: Silica gel was as effective in the treatment of recurrent herpes labialis as acyclovir and equally well tolerated and tended to take effect more quickly. Therefore, silica gel could prove a useful alternative to topical acyclovir.

Satisfaction of patients after treatment with botulinum toxin for dynamic facial lines.

OBJECTIVE: To gain first evidence on the patient satisfaction after treatment with botulinum toxin type A (BTX-A) and to check for differences in satisfaction with respect to clinical, psychologic, and sociodemographic parameters. METHODS: In this pilot study, 30 patients who had been treated with BTX-A within the last 3 months answered a standardized questionnaire (the Freiburg questionnaire on aesthetic dermatology and cosmetic surgery). The items assessed were attitudes on beauty and body, satisfaction with treatment outcome, and general quality of life. A prospective study consisting of the same items runs parallel and will be published later. RESULTS: More than 80% of the patients answered that the treatment had been beneficial to them. All patients would recommend treatment completely or mostly. Only a very small part of the patients was moderately stressed by the treatment. CONCLUSION: Injections with BTX-A is a satisfying and well-tolerated treatment of dynamic facial lines for all patients in this pilot study.