Pimecrolimus cream 1% for papulopustular rosacea: a randomized vehicle-controlled double-blind trial

BACKGROUND: Rosacea remains difficult to treat, despite many therapeutic options. OBJECTIVES: To investigate the effect of pimecrolimus cream 1% (Elidel; Novartis Pharma, Nuremberg, Germany) in the treatment of papulopustular rosacea. METHODS: Forty patients with rosacea (25 men and 15 women, mean age 58 years) were enrolled in a randomized, vehicle-controlled, double-blind study. For 4-8 weeks, patients applied pimecrolimus cream or vehicle twice daily to the involved areas on the face. Rosacea severity score, subjective severity assessment and quality of life assessment were obtained, along with photographic documentation. RESULTS: Both treatment groups of 20 patients showed an improvement after 4 weeks. The differences were not significant (P > 0 x 05) with regard to mean absolute values, mean percentage changes from baseline, or mean absolute values as differences from baseline for the total score or scores of the different clinical signs (erythema, papulation, scaling and pustules). In the subjective severity score and the quality of life assessment, there was also no significant difference between pimecrolimus and the vehicle (P > 0 x 05). CONCLUSIONS: Treatment of rosacea for 4-8 weeks with the topical calcineurin inhibitor pimecrolimus cream 1% was not more efficacious than treatment with the vehicle cream.     

Pimecrolimus 1% cream for the treatment of rosacea

Rosacea is a common inflammatory skin disorder; the pathogenesis is unclear. Various treatment options for rosacea are available, but most have limited effectiveness. The aim of this study was to investigate the efficacy and safety of 1% pimecrolimus cream for the treatment of rosacea. Thirty patients with rosacea were enrolled in this 4-week, single-center, open-label study of 1% pimecrolimus cream. Patients were instructed to apply the cream to their faces twice daily and were not permitted to use any other agents. Clinical efficacy was evaluated by a rosacea grading system using photographic documentation and a mexameter. The 26 patients who completed the study experienced significantly reduced rosacea clinical scores from 9.65 ± 1.79 at baseline to 7.27 ± 2.11 at the end of treatment (P < 0.05). The mexameter-measured erythema index decreased significantly from 418.54 ± 89.56 at baseline to 382.23 ± 80.04 at week 4 (P < 0.05). The side-effects were mostly transient local irritations. The results of this study suggest that 1% pimecrolimus cream is an effective and well-tolerated treatment for patients with mild to moderate inflammatory rosacea.     

A comparison of metronidazole 1% cream and pimecrolimus 1% cream in the treatment of patients with papulopustular rosacea: a randomized open‐label clinical trial

Background. There are various treatment options available for rosacea, depending on the subtype, but treatment is still generally unsatisfactory. Some reports have indicated beneficial effects of topical pimecrolimus. Aim. To compare the efficacy and safety of pimecrolimus 1% cream and metronidazole 1% cream in the treatment of patients with papulopustular rosacea (PR). Methods. A group of 49 patients with PR was investigated in this single‐centre, randomized, open‐label study. Patients were randomly assigned treatment with either pimecrolimus 1% cream or metronidazole 1% cream for 12 weeks. Response was evaluated by the inflammatory lesion count, the severity of facial erythema and telangiectasia, Physician’s Global Assessment (PGA), and safety and tolerability at baseline and at weeks 3, 6, 9 and 12. Results. In total, 48 patients completed the study. Both treatments were very effective in the treatment of PR. There were no significant differences between the treatments in inflammatory lesion counts, overall erythema severity scores and PGA evaluated from baseline to week 12 (P > 0.05). Neither treatment produced any clinically relevant improvement in telangiectasia. Conclusion. Pimecrolimus cream is no more efficacious than metronidazole cream in the treatment of PR.     

Long-term management of facial atopic eczema with pimecrolimus cream 1% in paediatric patients with mild to moderate disease

Background The aim of this post hoc analysis was to evaluate whether treatment of patients with atopic dermatitis (AD) with pimecrolimus cream 1% can decrease the development of flares necessitating the use of a topical corticosteroid on the face and thus reduce the need for use of topical corticosteroids in this sensitive skin area. Patients and methods In a controlled, double‐blind, multicentre study, 140 patients, aged 2 to 17 years, with facial involvement and mild to moderate disease after treatment of the initial flare with prednicarbate 0.25% cream were randomized to an intermittent treatment with pimecrolimus cream 1% twice daily or vehicle for 24 weeks. If a flare occurred, defined as an exacerbation (unacceptable severity of itching/scratching or onset of oozing) not controlled by study medication, patients were treated with prednicarbate 0.25% cream instead. Results Patients in the vehicle group needed prednicarbate treatment on the face on 20.7% of the days vs. 11.7% of the study days in the pimecrolimus group (P = 0.0024). Fifty per cent of patients in the pimecrolimus group had no flare on the face during the treatment period compared with 37.5% of patients in the vehicle group (P = 0.012). The median time to first flare in pimecrolimus‐treated patients was twice as long as in patients receiving vehicle (138 vs. 68 days, P = 0.01). Three adverse events (one case of skin burning) suspected to be related to use of the study medication were reported for three patients (3.9%) in the pimecrolimus group. Conclusion Long‐term intermittent treatment of facial AD in children and adolescents with pimecrolimus cream 1% does significantly reduce the need for topical corticosteroids.     

Treatment of rosacea with intense pulsed light: significant improvement and long-lasting results

Background  Rosacea is a common skin condition but the treatments currently available are not satisfactory.
Objectives  To assess the efficacy of intense pulsed light (IPL) for treatment of stage I rosacea (flushing, erythema and telangiectasia).
Methods  Thirty-four patients were treated, 25 women and nine men, mean age 47 years. The treatment employed was IPL 515–1200 nm, with a 560 nm cut-off filter. The fluence range was 24–32 J cm⁻². Four treatments were administered on the face at 3-week intervals. Erythema values were measured at baseline and at the end of the treatment period on the cheeks and chin. Digital photographs were assessed by a consultant dermatologist on a 10-point visual analogue scale (VAS). Patients' assessments were also made using a 10-point VAS. Outcome measures were repeated 6 months after treatment.
Results  After four treatments the mean reduction of the erythema values was 39% on the cheeks ( P  <   0·001) and 22% on the chin ( P  <   0·001). This was confirmed by photographic assessment where erythema improved by 46% and telangiectasia by 55% ( P  <   0·001). The severity of rosacea was reduced on average by 3·5 points on the 10-point VAS. Patients' and physicians' assessments of the overall improvement of rosacea were similar: more than 50% improvement was noticed in 73% and 83% of patients, respectively ( P  <   0·001). The results were sustained at 6 months. Side-effects were minimal and self-limiting.
Conclusions  IPL significantly reduces erythema and telangiectasia of rosacea and this is sustained for at least 6 months.     

Use of light-emitting diode photomodulation to reduce erythema and discomfort after intense pulsed light treatment of photodamage

Objectives This study evaluates the use of light‐emitting diode (LED) photomodulation therapy to accelerate resolution of post–intense pulsed light (IPL) erythema. Methods In this split‐face study, 15 subjects were randomized to receive LED treatment to one side of the face as determined by computer‐generated randomization numbers. All 15 subjects received a single IPL treatment for facial photodamage. Immediately after IPL treatment, one side of the face was treated for 35 s with the LED device. The other side was not treated. Subjects returned 24 h later for a second LED treatment on the same side of the face. Posttreatment erythema was rated on both sides of the face by the blinded investigator and by subjects immediately after IPL treatment, 24 h later, and 1 week later on a scale of 0% (no erythema) to 100% (severe erythema). Patients commented on posttreatment discomfort immediately after IPL treatment. Results Mean erythema scores on the first visit were significantly higher (P = 0.0054) on the side not treated with LED (52.7 ± 24.6) than on the LED‐treated side (43.3 ± 21.9). Visit 2 data showed a similar trend (P = 0.0281). The subjects reported similar findings with mean erythema scores on the first visit on the LED‐treated side (46.7 ± 25.3) compared with the untreated side (60.0 ± 23.3); the difference was significant (P = 0.0382). On the second visit, the mean erythema scores trended lower on the LED‐treated side (24.3 ± 22.1) than on the untreated side (27.9 ± 25.8), but the difference did not reach statistical significance (P = 0.1365). Erythema scores on both facial sides were 0 for all subjects 1 week after IPL treatment. Four patients commented that posttreatment discomfort was considerably less on the LED‐treated side immediately after treatment. Conclusion LED photomodulation treatment may accelerate the resolution of erythema and reduce posttreatment discomfort in IPL‐treated patients with photodamage.     

Randomized placebo-controlled trial of a flavonoid-rich plant extract-based cream in the treatment of rosacea

BACKGROUND: Biological research suggests that vascular changes may play a major role in rosacea pathogenesis. Chrysanthellum indicum is a plant-based extract containing a unique combination of phenylpropenoic acids, flavonoids and saponosids, and has a well-documented effect on vascular wall permeability and increase of the mechanical resistance of capillaries. OBJECTIVE: To determine the efficacy and safety of a cream containing 1%C. indicum extract with vitamin P properties in the treatment of rosacea. METHODS: This study included 246 patients diagnosed clinically as having moderate rosacea. Patients were randomly allocated to C. indicum extract-based cream (n = 125) and placebo (n = 121) groups. Patients were advised to apply the products on their face twice a day for a 12-week period. The patients were examined at the end of each 4-week period. Severity of erythema (graded by reference to six photographs), surface of erythema and rosacea overall severity scores were recorded at each visit on days 0, 28, 56 and 84. Investigators carried out a final efficacy assessment at the end of week 12. Volunteers' final overall efficacy assessment was recorded in a self-administered questionnaire. Adverse events were identified through examination, interview and collection of comments in patients' questionnaires. RESULTS: Treatment with the C. indicum extract-based cream resulted in significant improvement (P < 0.05) in severity of erythema, overall rosacea severity compared to baseline and placebo, and investigator and patient overall efficacy assessment scores (P = 0.046 and P = 0.001, respectively) compared with placebo scores. Adverse reactions were mild, and did not differ between the C. indicum extract-based cream and the placebo groups. CONCLUSION: Chrysanthellum indicum extract-based cream is an effective and well-tolerated topical agent for the treatment of moderate rosacea. The mode of action of the active ingredient suggests that additional efficacy might be expected from combination with other topical treatments.     

Randomized placebo-controlled trial of metronidazole 1% cream with sunscreen SPF 15 in treatment of rosacea

Background: Rosacea is a photoaggravated dermatosis responsive to treatment with topical and oral antibiotics. A formulation combining metronidazole 1% cream with sunscreen SPF 15 was developed for the treatment of rosacea. Objective: The objective of this study was to determine the safety and efficacy of a formulation combining metronidazole 1% cream with sunscreen SPF 15 in the treatment of moderate to severe rosacea. Methods: One hundred and twenty patients with moderate to severe rosacea were enrolled for a randomized, placebo-controlled (vehicle containing sunscreen with SPF 15), double-blind study. Study cream was applied twice daily to the entire face over a 12-week period. Results: Treatment with metronidazole 1% cream with sunscreen SPF 15 resulted in significant improvement (p <0.05) in inflammatory lesion count, erythema and telangiectasiae scores, and investigator and patient global assessment scores compared with baseline and placebo. Adverse reactions related to study medication were typically mild, occurred at the site of application, and were reversible. There was no difference between the safety profiles of metronidazole 1% cream with sunscreen SPF 15 and placebo. Conclusions: The combined topical formulation of metronidazole 1% cream with sunscreen SPF 15 was an effective, well-tolerated topical agent for the treatment of moderate to severe rosacea.     

Pimecrolimus 1% cream for the treatment of steroid-induced rosacea: an 8-week split-face clinical trial

BACKGROUND: Steroid-induced rosacea is a relatively common dermatosis that is caused by the prolonged application of topical steroid to the face. OBJECTIVES: The purpose of this investigator-blind, split-face study was to evaluate the efficacy and safety of pimecrolimus 1% cream for the treatment of steroid-induced rosacea. PATIENTS/METHODS: Patients were instructed to apply pimecrolimus 1% cream twice daily to the involved areas of a randomly allocated half side for the first 2 weeks, and to follow this by applying pimecrolimus 1% cream to both sides for a further 6 weeks. RESULTS: Fifteen of the 18 patients completed the 8-week study. After 1 week of application, a statistically significant improvement was observed for investigator's global assessments of erythema and papules on prior-treated sides (P-side). Later-treated sides (L-side) showed subsequent improvement after use of pimecrolimus on the L-side. Likewise, a statistically significant improvement was also observed for numbers of papules/pustules on P-sides after 1 week, and L-sides showed a significant improvement after application of pimecrolimus on the L-side. Comparative reflectance colorimetric assessments revealed that DeltaL*, Deltaa* and Deltab* tended to converge to zero during the first 4 weeks. A statistically significant improvement was observed for percentage area affected on P-sides after 1 week of application. The L-side showed a significant improvement after use of pimecrolimus cream on that side. The visual analogue scale of P-sides decreased more rapidly than those of L-sides. Cutaneous side-effects were mild and transient. CONCLUSIONS: This study suggests that pimecrolimus 1% cream is an effective and well-tolerated treatment for steroid-induced rosacea.     

Pimecrolimus 1% cream for oral erosive lichen planus: a 6‐week randomized,double‐blind,vehicle‐controlled study with a 6‐week open‐label extension to assess efficacy and safety

Objective To assess the efficacy and safety of topical pimecrolimus 1% cream in the treatment of oral erosive lichen planus. Design A 6‐week randomized, double‐blind, vehicle‐controlled phase followed by a 6‐week open‐label phase. Setting Outpatients of the Department of Dermatology, University of Utah. Patients Twenty‐one patients with oral erosive lichen planus were randomized and treated with either pimecrolimus 1% cream or vehicle cream. Intervention Pimecrolimus 1% cream, or its vehicle, were applied twice daily for 6 weeks to each side of the mouth with a 2 × 2 inch gauze pad folded in half and placed directly on the erosive lesion. Main Outcome Measures Efficacy was based on clinical evaluation of Investigator’s Global Assessment (IGA) of the overall severity of the disease, erythema, measurement of the size of any target erosion in millimetres, and assessment of spontaneous pain. Blood levels of pimecrolimus were monitored in all subjects on day 0 and repeated on day 7. Results Pimecrolimus 1% cream was superior to vehicle cream in reducing mean IGA, pain, and erosion size. For the vehicle group that entered the open‐label phase, pimecrolimus 1% cream improved the mean IGA, pain, erosion size, and erythema. Pimecrolimus levels were detected in nine out of 10 of the pimecrolimus‐treated subjects. These levels were consistently low. The pimecrolimus cream was well‐tolerated. No clinically relevant, drug‐related adverse events were reported. Conclusion Pimecrolimus 1% cream was superior to vehicle in reducing pain, erythema, decreasing erosion size, and improving overall severity of disease when compared with vehicle treatment.     

The treatment of facial atopic dermatitis in children who are intolerant of, or dependent on, topical corticosteroids: a randomized, controlled clinical trial

Background  Atopic dermatitis (AD) is most prevalent in areas of reduced skin barrier reserve, like face and neck, especially in children. Treatment with topical corticosteroids (TCS) is limited due to heightened risk of treatment-associated side-effects, thus necessitating alternative AD therapies.
Objectives  The primary study objective was to determine the efficacy of pimecrolimus cream 1% in children with mild–moderate facial AD dependent on/intolerant of TCS. Secondary objectives included effects on overall Eczema Area and Severity Index (EASI), head/neck EASI, pruritus severity and time to clearance of facial AD.
Methods  A multicentre, double-blind (DB) study of ≤ 6 weeks, followed by a 6-week, open-label (OL) phase was conducted. Two hundred patients (aged 2–11 years) were randomized 1 : 1 to pimecrolimus cream 1% ( n  =   99) or vehicle ( n  =   101) twice daily until clearance of facial AD or for a maximum of 6 weeks (DB phase). Sixteen patients receiving vehicle were allowed to switch to the OL phase at day 22.
Results  Significantly more pimecrolimus-treated vs. vehicle-treated patients were cleared/almost cleared of facial AD (Investigators' Global Assessment 0/1): 74·5% vs. 51·0%, P  <   0·001 (day 43) [57·1% vs. 36·0%, P  =   0·004 (day 22)]. Median time to clearance was 22·0 vs. 43·0 days (pimecrolimus vs. vehicle, respectively). Statistically significant differences for pimecrolimus vs. vehicle were also seen on head/neck EASI, overall EASI, and head/neck pruritus scores. Adverse events were mainly mild–moderate, occurring with similar frequency in both treatment groups.
Conclusions  In children with facial dermatitis intolerant of/dependent on TCS, pimecrolimus cream 1% effectively controls eczema and pruritus and is well tolerated.     

An open-label pilot study to evaluate the safety and efficacy of topically applied pimecrolimus cream for the treatment of steroid-induced rosacea-like eruption

BACKGROUND: Steroid-induced rosacea-like eruption is characterized by facial rosacea-like dermatitis in patients that have been treated with topical steroids for relatively long periods. OBJECTIVE: To evaluate the efficacy and tolerability of 1% pimecrolimus topical cream for steroid-induced rosacea-like eruption. METHODS: In an open-label pilot study, 40 patients were enrolled and instructed to apply 1% pimecrolimus cream twice daily for 6 weeks. Patients were evaluated by a rosacea clinical score, investigator's global assessment, overall erythema severity, and tolerability at weeks 0, 2, and 6. RESULTS: In 35 patients, the rosacea clinical score decreased significantly from 16.0+/-4.3 at baseline to 8.1+/-3.3 at week 2 and 4.2+/-2.5 at week 6 (P<0.0001). Investigator's global assessment was 4.1+/-1.1 (baseline), then decreased to 1.4+/-0.8 (week 2) and 0.5+/-0.6 (week 6) (P<0.0001). By week 6, 48.6% of the patients were clear. Overall erythema severity was 2.4+/-0.7 (baseline), 0.9+/-0.4 (week 2), and 0.3+/-0.4 (week 6) (P<0.0001). Cutaneous adverse events (local burning, stinging, and itching) occurred in 17.5%. CONCLUSION: Pimecrolimus cream might be efficacious, safe, and well tolerated for steroid-induced rosacea-like eruption. The small sample size and open label nature of this study is its limitation. Further double-blind, vehicle-controlled studies are needed.     

Enhancing effect of pretreatment with topical niacin in the treatment of rosacea‐associated erythema by 585‐nm pulsed dye laser in Koreans: a randomized,prospective, split‐face trial

Background Rosacea is a chronic dermatosis that is usually confined to the face. A pulsed dye laser (PDL) system has been proven to be effective in treating rosacea‐associated erythema and telangiectasias. Niacin is a cutaneous vasodilator that can increase the chromophore through increased blood flow. Objectives We hypothesized that increased blood flow by pretreatment with topical niacin could enhance the effect of PDL in the treatment of rosacea. Methods Eighteen Korean patients with rosacea were recruited. Three sessions of 585‐nm PDL using a subpurpuragenic dose with and without pretreatment with niacin cream were performed on randomly assigned half‐faces at 3‐week intervals. Erythema was assessed objectively by a polarization colour imaging system, and evaluations were also made by three blinded dermatologists. Patient satisfaction was evaluated using a 10‐point visual analogue scale. Results Fifteen patients completed this study. All patients showed an improvement in erythema after three sessions of PDL treatment both with and without niacin pretreatment (P = 0·023 and P = 0·009, respectively). There was no significant difference in the improvement of objective erythema between the two sides. However, based on physician assessment the overall clinical improvement on the niacin side was significantly higher (P = 0·005), and patient satisfaction was also higher on the niacin‐pretreated side (P = 0·007). There were no remarkable side‐effects, with the exception of transient erythema and oedema. Conclusions Pretreatment with topical niacin safely enhanced the effect of 585‐nm PDL treatment of rosacea‐associated erythema in Koreans. Application of niacin can be helpful in overcoming the relatively lower effect of subpurpuragenic PDL in dark‐skinned Asians.     

Pimecrolimus 1% cream versus betamethasone 17-valerate 0.1% cream in the treatment of facial discoid lupus erythematosus: a double-blind, randomized pilot study

Background.  Discoid lupus erythematosus (DLE) is commonly treated with topical agents, the most important of which are glucocorticosteroids. However, prolonged use of these agents, especially on sensitive areas such as the face, may result in side-effects (e.g. atrophy and telangiectases) by altering collagen synthesis. Therefore, alternative treatments are needed for these patients.
Aim.  To investigate and compare the efficacy of topical pimecrolimus 1% cream and topical betamethasone 17-valerate 0.1% cream on facial lesions of DLE.
Methods.  This was a randomized double-blind pilot study, performed in outpatient clinics of two major referral hospitals. Ten patients aged 20–53 years with moderate to severe DLE of the face were randomized into two groups for 8 weeks of treatment and 8 weeks of follow-up after treatment. In this double-blind study, one group applied pimecrolimus 1% cream twice daily and the other group applied betamethasone valerate 0.1% cream twice daily to facial lesions. Efficacy end-points included a combined score based on evaluation of erythema, infiltration and presence of scale.
Results.  Efficacy end-points showed significant improvement in both groups. A decrease of 86% and 73% in clinical severity scores was obtained for pimecrolimus and betamethasone, respectively ( P  = 0.043). There was no significant difference between the two groups in terms of efficacy ( P  = 0.1). No adverse effect was found at the end of the 8-week trial in any of our patients.
Conclusions.  The efficacy of pimecrolimus 1% cream is comparable with that of betamethasone valerate 0.1% cream in treating facial DLE.     

Comparative study of some treatment modalities of rosacea

Background   Rosacea is a disease of complex pathogenesis and variable response to various therapeutic methods.
Aim of the work   To evaluate and compare the efficacy, safety and side effects of some topical lines of treatment of rosacea.
Patients and methods   The study included 24 patients (23 females and 1 male) with rosacea on the face. They were classified into three groups – each including eight patients (16 face sides) – and treated with one of three topical agents (azelaic acid 20% cream, metronidazole 0.75% cream or permethrin 5% cream) on one side of the face and another one on the other side twice daily for 15 weeks.
Results   There was a significant improvement of lesions after 15 weeks of topical treatment with the three agents. Azelaic acid cream was significantly more effective on inflammatory lesions but not erythema than the other two creams. Side effects – mostly transient – were observed with topical creams with no significant difference. They included itching, burning sensation, oedema and scales. Patients who used azelaic acid 20% cream were more satisfied than with other modalities.
Conclusion   Azelaic acid 20% cream provides an effective and safe alternative to metronidazole 0.75% cream or permethrin 5% cream with the added benefit of increased patient satisfaction.     

Anti-inflammatory effect of pimecrolimus in the sodium lauryl sulphate test

Background Pimecrolimus is a calcineurin inhibitor used for the topical treatment of inflammatory skin diseases. We have shown previously that pimecrolimus cream is not effective on intact skin in the ultraviolet erythema test. Objective To test the anti‐inflammatory effect of pimecrolimus cream after damage of the skin barrier by sodium lauryl sulphate (SLS) in a randomised, placebo‐controlled, observer‐blinded study. Methods SLS (3% v/v) was applied under occlusion on the back of 36 healthy volunteers for 24 h. Subsequently, the test areas were treated for 24 h with pimecrolimus cream, 1% hydrocortisone in a hydrophilic ointment, and the vehicle alone over three consecutive days. One control area remained untreated. The erythema index and the transepidermal water loss (TEWL) served as readout parameters to assess the SLS‐induced skin irritation. Results Pimecrolimus cream and 1% hydrocortisone cream significantly reduced the SLS‐induced erythema. The two test preparations did not have a significant effect on the TEWL. Conclusion After damage to the skin barrier by SLS, pimecrolimus seems to penetrate into the skin as shown by a reduction of the irritation‐induced erythma. These data further support the notion that pimecrolimus is selectively effective in the treatment of skin disorders with an impaired function of the epidermal barrier.     

Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: Results of a randomized,double‐blind,vehicle‐controlled study

Background: Vitiligo is an acquired, pigmentary skin disorder which is disfiguring and difficult to treat. In an earlier open label study in adult patients with vitiligo, pimecrolimus cream 1% was reported to have similar efficacy as clobetasol propionate 0.05%. We performed a double‐blind, intrapatient comparison of pimecrolimus cream 1% with placebo cream. Patients and methods: Twenty adult Caucasians with symmetrical vitiligo (predominantly on extremities, none in the face) were treated b.i.d. for 6 months left/right with pimecrolimus/vehicle (N = 10) or vehicle/pimecrolimus (N = 10), respectively. Primary efficacy endpoint was the size of the target lesion at month 6 and secondary efficacy endpoint was re‐pigmentation. Results: Treatment with pimecrolimus cream 1% or vehicle resulted in no significant change in mean target lesion size. Modest repigmentation (1–25%) was noted with pimecrolimus at month 2 in 12 of 17 patients (vehicle: 9 of 17 patients). Afterwards, the number of patients who experienced an improvement of pigmentation steadily decreased (3 of 14 patients with pimecrolimus and 2 of 14 with placebo at month 6).Treatment was well tolerated.There were no treatment‐related adverse events, no induction of skin atrophy nor any other application site side effects. Conclusion: In this group of adult patients with symmetrical vitiligo, treatment of body lesions (except face) with pimecrolimus cream 1% could not be shown to be effective.     

Clinical and instrumental assessment of the effects of a new product based on hydroxypropyl chitosan and potassium azeloyl diglycinate in the management of rosacea

Background Rosacea is a chronic inflammatory skin disease affecting mostly facial skin. Its origin is multifactorial. Important steps in its treatment are avoidance of any triggering factor and control of skin inflammation. Aim To assess the benefit of topical applications of a new product (P‐3075). Patients/Methods A randomized, multicenter, double‐blind, placebo‐controlled, parallel‐group, pilot study was carried out to evaluate the efficacy and tolerability of a cream (P‐3075) based on 5% potassium azeloyl diglycinate (PAD, Azeloglicina^®) and 1% hydroxypropyl chitosan (HPCH). Forty‐two patients (rosacea stages I and II) were enrolled and randomized, 28 in the P‐3075 group and 14 in the placebo group. They were asked to apply the cream twice daily for 4 weeks. The main assessments were the objective quantification of erythema and skin hydration using the Mexameter^® and Corneometer^® devices, respectively. Clinical signs and symptoms were evaluated on a four‐point scale. Results The P‐3075 cream applied for 28 days was effective in skin protection by reducing erythema, evaluated both instrumentally and clinically. In addition, the clinical assessments of other symptoms such as flushing, stinging, and burning supported the beneficial effect of the P‐3075 cream. Conclusions The anti‐inflammatory and moisturizing effects of potassium azeloyl diglycinate combined with the protective properties of HPCH allow the new product to be a good candidate for controlling signs and symptoms of rosacea.     

Safety and efficacy of pimecrolimus cream 1% in the daily practice: Results of a patient self‐observation study in patients with atopic dermatitis

Background: Pimecrolimus cream 1% has proven to be well‐tolerated and effective in controlled clinical studies in patients with atopic dermatitis (AD). In a 15‐week patient self‐observation study, safety and efficacy was investigated in the daily practice. Patients and methods: 3502 patients with AD (mean age 26.2 ± 18 years, 62% female) received pimecrolimus cream 1% from 810 physicians in the German Federal Republic.The severity of the disease was assessed at baseline, two times during the 15‐week observation period and at the end of treatment.Patients recorded daily the degree of erythema and pruritus. At the end of treatment, safety and efficacy were assessed by the physician based on patient's daily records and by the patient. Results: The percentage of patients with severe or massive AD decreased from 25% to 7%, whereas the percentage of patients without or with mild symptoms increased from 9% to 55%.The efficacy of treatment was rated by physicians as good or very good in 83.5% of cases and by 79% of patients.At baseline 35% of the patients were free of flares as compared to 75% at the end of therapy. Disease control was better in patients who followed the recommended treatment algorithm for pimecrolimus cream.Tolerability was mostly rated as good or very good. Conclusion: Treatment with pimecrolimus cream 1% for patients with AD is well‐tolerated and effective in daily practice.     

A case of granulomatous rosacea successfully treated with pimecrolimus cream

A 43-year-old male attended with lesions on his face that had been present for 3 months. On dermatological examination, multiple papules and pustules were seen on the forehead, nose, bilateral cheeks and lower eyelids. The patient used systemic clindamycin and doxycycline and topical benzoyl peroxide therapies, but the lesions did not regress. Routine laboratory tests were normal. Histopathological examination of the lesions confirmed the diagnosis of granulomatous rosacea. Pimecrolimus cream 1% was applied to the lesions. The regression of lesions began in the first month and complete improvement was observed at the end of the fourth month of therapy. Rosacea is a chronic, inflammatory skin disorder characterized by remissions and relapses. Although it is known that the disease is a treatable disorder, it may be resistant to standard therapies and there is a need for new therapy alternatives in some patients. We present a case of granulomatous rosacea successfully treated with pimecrolimus cream and believe that pimecrolimus may be a good alternative for the treatment of granulomatous rosacea.