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1% pimecrolimus, 0.005% calcipotriol, and 0.1% betamethasone in the treatment of intertriginous psoriasis: a double-blind, randomized controlled study.
Arch Dermatol 2006; 142(9):1138-43AD

Abstract

OBJECTIVE

During the last decades, management of intertriginous psoriasis (IP) has been unsatisfactory because of the adverse effects associated with long-term corticosteroid application and the lack of alternatives. Recently, both pimecrolimus and tacrolimus have been investigated for this indication and shown to be safe and effective. So far, to our knowledge, a comparison of one of these drugs with standard regimens for IP has not been performed.

DESIGN

A single-center, 4-week, double-blind, randomized, vehicle-controlled comparison study to assess the safety and efficacy of 1% pimecrolimus, 0.005% calcipotriol, and 0.1% betamethasone valerate in the treatment of IP.

SETTING

Dermatologic hospital at Ruhr University of Bochum.

PATIENTS

Eighty adults with IP.

INTERVENTIONS

Treatment of IP with 1% pimecrolimus, 0.005% calcipotriol, 0.1% betamethasone, or the vehicle once daily for 28 days.

MAIN OUTCOME MEASURES

Mean reduction of the Modified Psoriasis Area and Severity Index (M-PASI) score after 28 days of treatment was considered the primary outcome measure, which was analyzed on an intention-to-treat basis. The secondary outcome was a visual analog scale score for itching.

RESULTS

After 4 weeks of treatment, the 3 active compounds and the vehicle resulted in a significant decrease in mean M-PASI score (86.4% for 0.1% betamethasone, 62.4% for 0.005% calcipotriol, 39.7% for 1% pimecrolimus, and 21.1% for vehicle). The 0.1% betamethasone was significantly more effective than 1% pimecrolimus during the study period (P<.05). No significant difference was found between 0.005% calcipotriol and 0.1% betamethasone and between 0.005% calcipotriol and 1% pimecrolimus. The visual analog scale score for pruritus decreased by 78% for 0.1% betamethasone, 57% for 0.005% calcipotriol, 35% for 1% pimecrolimus, and 43% for the vehicle, again demonstrating a clear advantage for the corticosteroid (P<.05).

CONCLUSIONS

The 1% pimecrolimus was shown to be less potent than 0.1% betamethasone in the treatment of IP. Considering the adverse-effect profile of long-term application of corticosteroids, occasional or intermittent rescue therapy with short-term topical corticosteroids and maintenance with a less potent agent, such as 1% pimecrolimus or 0.005% calcipotriol, might be appropriate for patients with IP in general practice.

Authors+Show Affiliations

Department of Dermatology and Allergology, Ruhr University of Bochum, Gudrunstrasse 56, D-44791 Bochum, Germany. a.kreuter@derma.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16983001

Citation

Kreuter, Alexander, et al. "1% Pimecrolimus, 0.005% Calcipotriol, and 0.1% Betamethasone in the Treatment of Intertriginous Psoriasis: a Double-blind, Randomized Controlled Study." Archives of Dermatology, vol. 142, no. 9, 2006, pp. 1138-43.
Kreuter A, Sommer A, Hyun J, et al. 1% pimecrolimus, 0.005% calcipotriol, and 0.1% betamethasone in the treatment of intertriginous psoriasis: a double-blind, randomized controlled study. Arch Dermatol. 2006;142(9):1138-43.
Kreuter, A., Sommer, A., Hyun, J., Bräutigam, M., Brockmeyer, N. H., Altmeyer, P., & Gambichler, T. (2006). 1% pimecrolimus, 0.005% calcipotriol, and 0.1% betamethasone in the treatment of intertriginous psoriasis: a double-blind, randomized controlled study. Archives of Dermatology, 142(9), pp. 1138-43.
Kreuter A, et al. 1% Pimecrolimus, 0.005% Calcipotriol, and 0.1% Betamethasone in the Treatment of Intertriginous Psoriasis: a Double-blind, Randomized Controlled Study. Arch Dermatol. 2006;142(9):1138-43. PubMed PMID: 16983001.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 1% pimecrolimus, 0.005% calcipotriol, and 0.1% betamethasone in the treatment of intertriginous psoriasis: a double-blind, randomized controlled study. AU - Kreuter,Alexander, AU - Sommer,Anna, AU - Hyun,Julia, AU - Bräutigam,Matthias, AU - Brockmeyer,Norbert H, AU - Altmeyer,Peter, AU - Gambichler,Thilo, PY - 2006/9/20/pubmed PY - 2006/10/13/medline PY - 2006/9/20/entrez SP - 1138 EP - 43 JF - Archives of dermatology JO - Arch Dermatol VL - 142 IS - 9 N2 - OBJECTIVE: During the last decades, management of intertriginous psoriasis (IP) has been unsatisfactory because of the adverse effects associated with long-term corticosteroid application and the lack of alternatives. Recently, both pimecrolimus and tacrolimus have been investigated for this indication and shown to be safe and effective. So far, to our knowledge, a comparison of one of these drugs with standard regimens for IP has not been performed. DESIGN: A single-center, 4-week, double-blind, randomized, vehicle-controlled comparison study to assess the safety and efficacy of 1% pimecrolimus, 0.005% calcipotriol, and 0.1% betamethasone valerate in the treatment of IP. SETTING: Dermatologic hospital at Ruhr University of Bochum. PATIENTS: Eighty adults with IP. INTERVENTIONS: Treatment of IP with 1% pimecrolimus, 0.005% calcipotriol, 0.1% betamethasone, or the vehicle once daily for 28 days. MAIN OUTCOME MEASURES: Mean reduction of the Modified Psoriasis Area and Severity Index (M-PASI) score after 28 days of treatment was considered the primary outcome measure, which was analyzed on an intention-to-treat basis. The secondary outcome was a visual analog scale score for itching. RESULTS: After 4 weeks of treatment, the 3 active compounds and the vehicle resulted in a significant decrease in mean M-PASI score (86.4% for 0.1% betamethasone, 62.4% for 0.005% calcipotriol, 39.7% for 1% pimecrolimus, and 21.1% for vehicle). The 0.1% betamethasone was significantly more effective than 1% pimecrolimus during the study period (P<.05). No significant difference was found between 0.005% calcipotriol and 0.1% betamethasone and between 0.005% calcipotriol and 1% pimecrolimus. The visual analog scale score for pruritus decreased by 78% for 0.1% betamethasone, 57% for 0.005% calcipotriol, 35% for 1% pimecrolimus, and 43% for the vehicle, again demonstrating a clear advantage for the corticosteroid (P<.05). CONCLUSIONS: The 1% pimecrolimus was shown to be less potent than 0.1% betamethasone in the treatment of IP. Considering the adverse-effect profile of long-term application of corticosteroids, occasional or intermittent rescue therapy with short-term topical corticosteroids and maintenance with a less potent agent, such as 1% pimecrolimus or 0.005% calcipotriol, might be appropriate for patients with IP in general practice. SN - 0003-987X UR - https://www.unboundmedicine.com/medline/citation/16983001/1_pimecrolimus_0_005_calcipotriol_and_0_1_betamethasone_in_the_treatment_of_intertriginous_psoriasis:_a_double_blind_randomized_controlled_study_ L2 - https://jamanetwork.com/journals/jamadermatology/fullarticle/10.1001/archderm.142.9.1138 DB - PRIME DP - Unbound Medicine ER -