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Original Paper

Health-Related Quality of Life and Patient-Defined Benefit of Clobetasol 0.05% in Women with Chronic Lichen Sclerosus of the Vulva

Schwegler J.a · Schwarz J.a · Eulenburg C.b · Blome C.c · Ihnen M.a · Mahner S.a · Jaenicke F.a · Augustin M.c, d · Woelber L.a

Author affiliations

aDepartment of Gynaecology, bDepartment of Medical Biometry and Epidemiology, cGerman Centre for Health Services Research in Dermatology (CVderm), Institute for Health Services Research in Dermatology and Nursing, and dDepartment of Dermatology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany

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Dermatology 2011;223:152–160

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: January 19, 2011
Accepted: September 03, 2011
Published online: October 11, 2011
Issue release date: November 2011

Number of Print Pages: 9
Number of Figures: 1
Number of Tables: 6

ISSN: 1018-8665 (Print)
eISSN: 1421-9832 (Online)

For additional information: https://www.karger.com/DRM

Abstract

Background: This study investigates the health-related quality of life in patients with vulvar lichen sclerosus (LS) and the patient-defined therapeutic benefit of clobetasol. Methods: A survey analysis of 96 women with LS after treatment with clobetasol was performed. Quality of life was assessed with the Skindex-29. The Patient Benefit Index (PBI) was used to determine the therapeutic benefit. Results: The overall response rate was 59.2%. Quality of life was most impaired by somatic symptoms (scale ‘Symptoms’ score 3.2) and emotional stress (scale ‘Emotions’ score 3.1), while social interactions (scale ‘Functioning’ score 1.9) played an inferior role (p < 0.001). Primary therapeutic goals ‘to have confidence in the therapy’ and ‘to be free of itching’ were achieved in 73.2 and 69.0% of patients who indicated the goal applied to them. The global PBI score was 3.06. In 93.2% of patients it was >1, indicating a potential benefit from clobetasol. Conclusion: Topical clobetasol is of potential therapeutic benefit for patients with vulvar LS and might therefore improve quality of life.

© 2011 S. Karger AG, Basel


References

  1. Murphy R: Lichen sclerosus. Dermatol Clin 2010;28:707–715.
  2. Eberz B, Berghold A, Regauer S: High prevalence of concomitant anogenital lichen sclerosus and extragenital psoriasis in adult women. Obstet Gynecol 2008;111:1143–1147.
  3. Goldstein AT, Marinoff SC, Christopher K, Srodon M: Prevalence of vulvar lichen sclerosus in a general gynecology practice. J Reprod Med 2005;50:477–480.
  4. Powell J, Wojnarowska F: Lichen sclerosus. Lancet 1999;353:1777–1783.
  5. Reid R, Greenberg MD, Daoud Y, Husain M, Selvaggi S, Wilkinson E: Colposcopic findings in women with vulvar pain syndromes. A preliminary report. J Reprod Med 1988;33:523–532.
  6. Meffert JJ, Davis BM, Grimwood RE: Lichen sclerosus. J Am Acad Dermatol 1995;32:393–416, quiz 417–418.
  7. Gao XH, Barnardo MC, Winsey S, Ahmad T, Cook J, Agudelo JD, Zhai N, Powell JJ, Fuggle SV, Wojnarowska F: The association between HLA DR, DQ antigens, and vulval lichen sclerosus in the UK: HLA DRB112 and its associated DRB112/DQB10301/04/09/010 haplotype confers susceptibility to vulval lichen sclerosus, and HLA DRB10301/04 and its associated DRB10301/04/DQB10201/02/03 haplotype protects from vulval lichen sclerosus. J Invest Dermatol 2005;125:895–899.
  8. Gross T, Wagner A, Ugurel S, Tilgen W, Reinhold U: Identification of Tia-1+ and granzyme B+ cytotoxic T cells in lichen sclerosus et atrophicus. Dermatology 2001;202:198–202.
  9. Farrell AM, Dean D, Millard PR, Charnock FM, Wojnarowska F: Cytokine alterations in lichen sclerosus: An immunohistochemical study. Br J Dermatol 2006;155:931–940.
  10. Regauer S, Liegl B, Reich O, Beham-Schmid C: Vasculitis in lichen sclerosus: an under recognized feature? Histopathology 2004;45:237–244.
  11. Hagedorn M, Goluke T, Mall G: Lichen sclerosus und Vulvakarzinom. J Dtsch Dermatol Ges 2003;1:864–868.
  12. Küng F: Lichen sclerosus – hormonelle Therapie heute. Gynäkol Geburtshilfliche Rundsch 2000;40:29–32.
  13. Cooper SM, Gao XH, Powell JJ, Wojnarowska F: Does treatment of vulvar lichen sclerosus influence its prognosis? Arch Dermatol 2004;140:702–706.
  14. Bracco GL, Carli P, Sonni L, Maestrini G, De Marco A, Taddei GL, Cattaneo A: Clinical and histologic effects of topical treatments of vulval lichen sclerosus. A critical evaluation. J Reprod Med 1993;38:37–40.
  15. Augustin M, Amon U, Bullinger M, Gieler U: Empfehlungen zur Erfassung der Lebensqualität in der Dermatologie. Dermatol Psychosom 2000;1:76–82.
    External Resources
  16. Blome C, Maares J, Diepgen T, Jeffrustenbach S, Augustin M: Measurement of patient-relevant benefits in the treatment of chronic hand eczema – a novel approach. Contact Dermatitis 2009;61:39–45.
  17. Augustin M, Radtke MA, Zschocke I, Blome C, Behechtnejad J, Schafer I, Reusch M, Mielke V, Rustenbach SJ: The Patient Benefit Index: A novel approach in patient-defined outcomes measurement for skin diseases. Arch Dermatol Res 2009;301:561–571.
  18. Zschocke I, Hammelmann U, Augustin M: Therapeutischer Nutzen in der dermatologischen Behandlung. Hautarzt 2005;56:839–846.
  19. Schäfer R, Reich C, Augustin M: Quantitative Nutzenbewertung aus Patientensicht – der Patient Benefit Index (PBI). Kongress Medizin und Gesellschaft, Augsburg, 17–21 September 2007, German Medical Science GMS Publishing House; 2007 Doc 07 gmds 676 2007.
  20. Zentner A, Velasco-Garrido M, Busse R: Methoden zur vergleichenden Bewertung pharmazeutischer Produkte. Bericht Nr 122 Deutsches Institut für Medizinische Dokumentation und Information (DIMDI) 2005; GMS Health Technol Assess 1: Doc 09.
  21. Berglund NL, Rylander E: Vulvar pain, sexual behavior and genital infections in a young population: a pilot study. Acta Obstet Gynecol Scand 2002;81:738–742.
  22. Lamont J, Randazzo J, Farad M, Wilkins A, Daya D: Psychosexual and social profiles of women with vulvodynia. J Sex Marital Ther 2001;27:551–555.
  23. Reed BD, Haefner HK, Punch MR, Roth RS, Gorenflo DW, Gillespie BW: Psychosocial and sexual functioning in women with vulvodynia and chronic pelvic pain. A comparative evaluation. J Reprod Med 2000;45:624–632.
  24. Sadownik L: Clinical profile of vulvodynia patients. A prospective study of 300 patients. J Reprod Med 2000;45:679–684.
  25. Chren MM, Lasek RJ, Quinn LM, Mostow EN, Zyzanski SJ: Skindex, a quality-of-life measure for patients with skin disease: reliability, validity, and responsiveness. J Invest Dermatol 1996;107:707–713.
  26. Chren MM, Lasek RJ, Flocke SA, Zyzanski SJ: Improved discriminative and evaluative capability of a refined version of Skindex, a quality-of-life instrument for patients with skin diseases. Arch Dermatol 1997;133:1433–1440.
  27. Augustin M, Wenninger K, Amon U, Schroth MJ, Kuster W, Chren M, Kupfer J, Gieler U: German adaptation of the Skindex-29 questionnaire on quality of life in dermatology: validation and clinical results. Dermatology 2004;209:14–20.
  28. Ponte M, Klemperer E, Sahay A, Chren MM: Effects of vulvodynia on quality of life. J Am Acad Dermatol 2009;60:70–76.
  29. Schmidt S, Bauer A, Greif C, Merker A, Elsner P, Strauss B: Vulvar pain. Psychological profiles and treatment responses. J Reprod Med 2001;46:377–384.
  30. Nijsten T, Sampogna F, Abeni D: Categorization of Skindex-29 scores using mixture analysis. Dermatology 2009;218:151–154.
  31. Nijsten TE, Sampogna F, Chren MM, Abeni DD: Testing and reducing Skindex-29 using Rasch analysis: Skindex-17. J Invest Dermatol 2006;126:1244–1250.
  32. Augustin M, Reich C, Schaefer I, Zschocke I, Rustenbach SJ: Development and validation of a new instrument for the assessment of patient-defined benefit in the treatment of acne. J Dtsch Dermatol Ges 2008;6:113–120.
  33. Blome C, Augustin M, Siepmann D, Phan NQ, Rustenbach SJ, Stander S: Measuring patient-relevant benefits in pruritus treatment: development and validation of a specific outcomes tool. Br J Dermatol 2009;161:1143–1148.
  34. Augustin M, Schafer I, Rabini S, Lee-Seifert C, Radtke M, Rustenbach SJ: Assessing the value of supportive skin care: development and validation of an instrument for evaluating patient-relevant benefit. Dermatology 2009;218:255–259.
  35. Bachmann GA, Rosen R, Arnold LD, Burd I, Rhoads GG, Leiblum SR, Avis N: Chronic vulvar and other gynecologic pain: prevalence and characteristics in a self-reported survey. J Reprod Med 2006;51:3–9.
  36. Arnold LD, Bachmann GA, Rosen R, Kelly S, Rhoads GG: Vulvodynia: characteristics and associations with comorbidities and quality of life. Obstet Gynecol 2006;107:617–624.
  37. Jensen JT, Wilder K, Carr K, Romm J, Hansen A: Quality of life and sexual function after evaluation and treatment at a referral center for vulvovaginal disorders. Am J Obstet Gynecol 2003;188:1629–1635; discussion 1635–1637.
  38. Sargeant HA, O’Callaghan FV: The impact of chronic vulval pain on quality of life and psychosocial well-being. Aust N Z J Obstet Gynaecol 2007;47:235–239.
  39. Bullinger M: Methodische Grundlagen und Aspekte der Lebensqualität. Dtsch Med Wochenschr 2006;131(19 suppl 1):S5–S7.
  40. Marini A, Blecken S, Ruzicka T, Hengge UR: Lichen sclerosus. Neues zur Pathogenese und Therapie. Hautarzt 2005;56:550–555.
  41. Augustin M, Gajur AI, Reich C, Rustenbach SJ, Schaefer I: Benefit evaluation in vitiligo treatment: development and validation of a patient-defined outcome questionnaire. Dermatology 2008;217:101–106.
  42. Hengge UR, Krause W, Hofmann H, Stadler R, Gross G, Meurer M, Brinkmeier T, Frosch P, Moll I, Fritsch P, Muller K, Meykadeh N, Marini A, Ruzicka T, Gollnick H: Multicentre, phase II trial on the safety and efficacy of topical tacrolimus ointment for the treatment of lichen sclerosus. Br J Dermatol 2006;155:1021–1028.
  43. Lorenz B, Kaufman RH, Kutzner SK: Lichen sclerosus. Therapy with clobetasol propionate. J Reprod Med 1998;43:790–794.
  44. Bornstein J, Heifetz S, Kellner Y, Stolar Z, Abramovici H: Clobetasol dipropionate 0.05% versus testosterone propionate 2% topical application for severe vulvar lichen sclerosus. Am J Obstet Gynecol 1998;178:80–84.
  45. Renaud-Vilmer C, Cavelier-Balloy B, Porcher R, Dubertret L: Vulvar lichen sclerosus: effect of long-term topical application of a potent steroid on the course of the disease. Arch Dermatol 2004;140:709–712.
  46. Goldstein AT, Creasey A, Pfau R, Phillips D, Burrows LJ: A double-blind, randomized controlled trial of clobetasol versus pimecrolimus in patients with vulvar lichen sclerosus. J Am Acad Dermatol 2011;64:e99–e104.
  47. Neill SM, Lewis FM, Tatnall FM, Cox NH: British Association of Dermatologists’ guidelines for the management of lichen sclerosus. Br J Dermatol 2010;163:672–682.

Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: January 19, 2011
Accepted: September 03, 2011
Published online: October 11, 2011
Issue release date: November 2011

Number of Print Pages: 9
Number of Figures: 1
Number of Tables: 6

ISSN: 1018-8665 (Print)
eISSN: 1421-9832 (Online)

For additional information: https://www.karger.com/DRM


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