Pimecrolimus cream 1% for treatment of vulvar lichen simplex chronicus: an open-label, preliminary trial.

BACKGROUND: To evaluate efficacy and safety of pimecrolimus cream 1% twice daily for treatment of vulvar lichen simplex chronicus (LSC). METHODS: Patients in this 12-week, open-label study had biopsy-proven vulvar LSC. Inclusion criteria were patient-reported Visual Analog Scale for Pruritus Relief > or = 3 (VAS-PR, 0 cm = no itching to 10 cm = severe itching) and Investigator's Global Assessment > or = 2 (IGA, 0 = no disease to 3 = severe disease). Safety was evaluated by adverse event reports and pimecrolimus blood level measurements. RESULTS: Twelve women aged 25-53 years were enrolled. The median pruritus score (VAS-PR) decreased from 6 (min. 4.9, max. 9.0) at baseline to 0 cm at week 4 (max. 4.2), week 8 (max. 3.1) and week 12 (max. 2.1). Seven patients reported complete resolution of pruritus by week 4. Median IGA decreased from 2.5 (min. 2, max. 3) at baseline to 0 (min. 0, max. 2) at week 12. Erythema, excoriation, and lichenification improved for all patients. Pimecrolimus blood concentration for all samples was below the limit of quantification, 0.3 ng/ml. No adverse events were reported. CONCLUSIONS: In this exploratory study, signs and symptoms of vulvar LSC improved for all women and pimecrolimus cream showed a favorable safety profile. Larger prospective studies are needed to further evaluate pimecrolimus for treatment of vulvar LSC.

Skin reactions to pimecrolimus cream 1% in patients allergic to propylene glycol: a double-blind randomized study.

BACKGROUND: The low concentration of propylene glycol (PG) in pimecrolimus cream makes it unlikely that the cream will induce a PG-related irritant or allergic contact dermatitis. OBJECTIVE: To assess reactions to pimecrolimus cream in patients who are allergic to PG. METHODS: A pilot double-blind within-patient study in 20 patients, with patch testing followed by a repeated open application test (ROAT). Limitations were that patch tests and ROATs were performed on normal skin, which may be less likely to develop an allergic response than would areas of active dermatitis. RESULTS: Positive PG patch-test results were confirmed in 16 patients. Patch-test scores were compatible with allergic reactions in only two patients. However, ROAT scores were negative for these two patients. Reactions with pimecrolimus or vehicle during ROAT were identified in three patients, but an allergic reaction was uncertain because none of these patients reacted with both pimecrolimus cream and vehicle. Reactions with pimecrolimus were significantly less frequent (p<.01) and less severe (p=.02) than with PG. CONCLUSION: In patients allergic to PG, pimecrolimus cream showed a very low potential to elicit allergic skin reactions.

Retrospective analysis of pimecrolimus cream 1% for treatment of facial vitiligo.

OBJECTIVE: To explore the effectiveness of pimecrolimus cream 1% used twice daily (BID) for the treatment of facial vitiligo. METHODS: Patients who had used pimecrolimus cream 1% monotherapy BID for at least 3 months and who had photographs taken at baseline and after initiation of therapy were analyzed in a retrospective study. The total affected surface area (cm2) of facial vitiligo in the baseline and follow-up photographs was compared. The extent of facial depigmentation was scored using a 7-point scale (0 = no disease to 6 = 100% involvement). RESULTS: Eight patients met study entry criteria. Mean time from initiation of treatment to the final follow-up visit was 11 months (SD +/- 7.5 months). Mean affected surface area at baseline and follow-up were 79.40 cm2 and 17.96 cm2, respectively, (P = .012) with a mean percent improvement 72.5% (SD +/- 20.4%). Mean depigmentation score decreased from 2.8 at baseline to 1.4 at follow-up. No adverse events were reported. CONCLUSION: Pimecrolimus cream 1% may be a viable alternative to current therapies for the treatment of facial vitiligo.

An exploratory study to evaluate the efficacy of pimecrolimus cream 1% for the treatment of pityriasis alba.

BACKGROUND: Use of topical corticosteroids for the treatment of pityriasis alba is limited by their potential side-effects, such as skin atrophy especially with long-term use on the face. Pimecrolimus cream 1% is a topical calcineurin inhibitor that has anti-inflammatory properties, lacks the cutaneous side-effects associated with steroids, and provide a potential benefit for the treatment of pityriasis alba. METHODS: This 10-patient, prospective, single-arm, open-label, single-center, 12-week, investigator-initiated proof of concept study assessed the efficacy, safety, and patient acceptance of pimecrolimus cream 1% twice daily. In addition to pimecrolimus cream, patients used facial emollient containing SPF 15 sunscreen and mild soap-free cleanser. Efficacy assessments were Investigator Global Assessment (IGA) of disease severity and evaluation of uneven skin color, scaling, eczema, follicular keratosis, and pruritus. All efficacy assessments were reported on a 4-point scale (0 = none to 3 = severe). RESULTS: Of the 10 patients enrolled (aged: 12-35 years), all had intensive sun-exposure, 90% had skin type IV-V, and 80% completed the 12-week treatment. At baseline, mean IGA was 1.20 (mild-moderate), uneven skin color was 2.3 (moderate-severe) and scaling was 1.2 (mild). IGA decreased to 0.25 by week 12, uneven skin color improved by week 3 with near complete resolution by week 12 (mean = 0.38) and scaling resolved at week 3. Pruritus, eczema, and follicular keratosis remained at low levels from baseline throughout the course of the study. Patients consistently reported satisfaction with the treatment ("satisfied" or "very satisfied"). No adverse events were reported. CONCLUSIONS: Pimecrolimus cream 1% may represent an alternative for the treatment of pityriasis alba.

Results of a randomized, double-blind, vehicle-controlled efficacy trial of pimecrolimus cream 1% for the treatment of moderate to severe facial seborrheic dermatitis.

BACKGROUND: Seborrheic dermatitis is commonly treated with anti-inflammatory products, including topical corticosteroids. Pimecrolimus cream 1% also exerts anti-inflammatory activity by inhibiting T-cell cytokine production. OBJECTIVE: We sought to compare the efficacy and safety of twice-daily pimecrolimus for treatment of moderate to severe facial seborrheic dermatitis. METHODS: This double-blind, vehicle-controlled, 4-week trial randomized patients with seborrheic dermatitis to pimecrolimus or vehicle (1:1). Clinical assessments (erythema [0-3] and scaling [0-3] combined for a total area score [0-6]) were performed at weeks 0, 2, and 4. Inclusion criteria included total area score 4 or greater and erythema 2 or greater. The prespecified primary variable, change from baseline in total area score at week 4, was analyzed using a two-sample t test for intent-to-treat and per protocol populations. RESULTS: In all, 96 adults of mean age 59.6 years, 88.5% male, were randomized (n = 47 pimecrolimus; 49 vehicle). At week 4, the mean change from baseline in total area score was 3.7 versus 3.3 for pimecrolimus and vehicle groups, respectively (intent-to-treat: P = .1913; 95% confidence interval (CI) for difference [-0.195, 0.961]). Per protocol analysis (n = 41 pimecrolimus; 46 vehicle) indicated a significant difference between groups (mean change 3.9 pimecrolimus vs 3.2 vehicle; P = .0156; CI [0.129, 1.197]). The superiority of pimecrolimus was observed as early as week 2 (intent-to-treat: P = .0062; CI [0.132, 0.777]; per protocol: P = .0012; CI [0.410, 1.593]). No drug-related serious adverse events occurred. The most frequent drug-related adverse events were local, mild, and transient (pimecrolimus = 26%; vehicle = 12%). LIMITATIONS: Generalizability is limited by the elderly male study population. CONCLUSION: This study suggests that pimecrolimus cream 1% is an effective and well-tolerated treatment for moderate to severe facial seborrheic dermatitis.

Pimecrolimus cream 1% in the treatment of intertriginous psoriasis: a double-blind, randomized study.

BACKGROUND: Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous areas to cutaneous side effects, such as irritation and striae. Pimecrolimus, a well-tolerated, nonatrophogenic, skin-selective inflammatory cytokine inhibitor, has been shown to be effective in the treatment of psoriasis when applied topically under occlusion. OBJECTIVE: This study evaluated the efficacy and safety of pimecrolimus cream 1% versus vehicle twice a day in the treatment of inverse psoriasis. Methods This was a double-blind, randomized, vehicle-controlled study in 57 patients with moderate to severe inverse psoriasis. Patients were evaluated using Investigator's Global Assessment of overall severity, Target Area Score, and Patient Self-Assessment. RESULTS: A significant between-group difference was observed early on, with 54% of the pimecrolimus group versus 21% of the vehicle group having an Investigator's Global Assessment score of 0 or 1 (clear or almost clear) at week 2 ( P = .0169). By week 8, 71% of the pimecrolimus group had an Investigator's Global Assessment score of 0 or 1. Change from baseline in Target Area Score was -2.4 (pimecrolimus group) compared with -0.7 (vehicle) at day 3 ( P < .0001). By week 8, 82% of patients using pimecrolimus scored their disease as well or completely controlled versus 41% of the vehicle group ( P = .0007). Adverse events were similar between groups. CONCLUSION: Pimecrolimus cream 1% is an effective treatment for inverse psoriasis with a rapid onset of action, and is safe and well-tolerated.