Multicentre, phase II trial on the safety and efficacy of topical tacrolimus ointment for the treatment of lichen sclerosus

Authors: Hengge, U.R.; Krause, W.¹; Hofmann, H.²; Stadler, R.³; Gross, G.⁴; Meurer, M.⁵; Brinkmeier, T.⁶; Frosch, P.⁶; Moll, I.⁷; Fritsch, P.⁸; Müller, K.; Meykadeh, N.; Marini, A.; Ruzicka, T.; Gollnick, H.⁹

Source: British Journal of Dermatology, Volume 155, Number 5, November 2006 , pp. 1021-1028(8)

Publisher: Wiley-Blackwell

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Abstract:

Summary Background

Lichen sclerosus is a chronic inflammatory autoimmune disease causing significant sclerosis, atrophy and pruritus. Treatment remains unsatisfactory, with potent corticosteroids being the most effective therapy. Objectives

To conduct a multicentre, phase II trial to assess the safety and efficacy of tacrolimus ointment 0·1% for the treatment of lichen sclerosus with a follow-up period of 18 months at 10 university and teaching hospitals in Germany and Austria. Methods

Eighty-four patients (49 women, 32 men and three girls) aged between 5 and 85 years with long-standing, active lichen sclerosus (79 with anogenital and five with extragenital localization) were treated with topical tacrolimus ointment 0·1% twice daily for 16 weeks. Computerized analysis of the lesional area was performed. The primary endpoint was clearance of active lichen sclerosus. Secondary endpoints were time to optimal response, reduction of sclerosis and duration of remission. Results

The primary endpoint (clearance of active lichen sclerosus) was reached by 43% of patients at 24 weeks of treatment. Partial resolution was reached in 34% of patients. Maximal effects occurred between week 10 and 24 of therapy. Treatment led to a significant reduction of the total lesional area (P < 0·01) and to a significant decline in the total symptom score (P < 0·005). Symptoms (e.g. itching) and findings (erythema, erosions and induration) showed significant improvement. No serious adverse events were observed. There were three (9%) recurrences during the follow-up period. Conclusions

Topical tacrolimus ointment 0·1% was safe and effective for the treatment of long-standing active lichen sclerosus.

Keywords: autoimmune disease; calcineurin antagonist; lichen sclerosus; tacrolimus

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1365-2133.2006.07446.x

Affiliations: 1: Department of Andrology and Venereology, Philipps-University Marburg, Marburg, Germany 2: Department of Dermatology and Allergology, Technical University, Munich, Germany 3: Department of Dermatology, Hospital of Minden, Minden, Germany 4: Department of Dermatology, University of Rostock, Rostock, Germany 5: Department of Dermatology, Carl Gustav Carus University, Dresden, Germany 6: Department of Dermatology, Community Hospital Dortmund and University of Witten/Herdecke, Dortmund, Germany 7: Department of Dermatology, University of Hamburg, Hamburg, Germany 8: Department of Dermatology and Venereology, University of Innsbruck, Innsbruck, Austria 9: Department of Dermatology and Venereology, Otto-von-Guericke-University, Magdeburg, Germany

Publication date: 2006-11-01

Multicentre, phase II trial on the safety and efficacy of topical tacrolimus ointment for the treatment of lichen sclerosus

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