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Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: results of a randomized, double-blind, vehicle-controlled study.
J Dtsch Dermatol Ges 2006; 4(11):942-6JD

Abstract

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.

Authors+Show Affiliations

Division of General Dermatology, Department of Dermatology, University of Vienna, Vienna General Hospital, Vienna, Austria.No 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 ger

PubMed ID

17081269

Citation

Dawid, Markus, et al. "Efficacy and Safety of Pimecrolimus Cream 1% in Adult Patients With Vitiligo: Results of a Randomized, Double-blind, Vehicle-controlled Study." Journal Der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG, vol. 4, no. 11, 2006, pp. 942-6.
Dawid M, Veensalu M, Grassberger M, et al. Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: results of a randomized, double-blind, vehicle-controlled study. J Dtsch Dermatol Ges. 2006;4(11):942-6.
Dawid, M., Veensalu, M., Grassberger, M., & Wolff, K. (2006). Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: results of a randomized, double-blind, vehicle-controlled study. Journal Der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG, 4(11), pp. 942-6.
Dawid M, et al. Efficacy and Safety of Pimecrolimus Cream 1% in Adult Patients With Vitiligo: Results of a Randomized, Double-blind, Vehicle-controlled Study. J Dtsch Dermatol Ges. 2006;4(11):942-6. PubMed PMID: 17081269.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: results of a randomized, double-blind, vehicle-controlled study. AU - Dawid,Markus, AU - Veensalu,Marge, AU - Grassberger,Maximilian, AU - Wolff,Klaus, PY - 2006/11/4/pubmed PY - 2007/1/24/medline PY - 2006/11/4/entrez SP - 942 EP - 6 JF - Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG JO - J Dtsch Dermatol Ges VL - 4 IS - 11 N2 - 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. SN - 1610-0387 UR - https://www.unboundmedicine.com/medline/citation/17081269/Efficacy_and_safety_of_pimecrolimus_cream_1_in_adult_patients_with_vitiligo:_results_of_a_randomized_double_blind_vehicle_controlled_study_ L2 - https://doi.org/10.1111/j.1610-0387.2006.06124.x DB - PRIME DP - Unbound Medicine ER -