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Patient reported outcomes: Effectiveness of hormonal treatments for acne

Patient reported outcomes: Effectiveness of hormonal treatments for acne. Jerry Tan MD, FRCP 1 Karen Y. Fung PhD 2 1 University of Western Ontario and 2 University of Windsor, Windsor, Ont. . Declarations. Conflict of interest: Study sponsored by Berlex, Roche, Stiefel, Dermik

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Patient reported outcomes: Effectiveness of hormonal treatments for acne

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  1. Patient reported outcomes:Effectiveness of hormonal treatments for acne Jerry Tan MD, FRCP1 Karen Y. Fung PhD2 1University of Western Ontario and 2University of Windsor, Windsor, Ont.

  2. Declarations • Conflict of interest: • Study sponsored by Berlex, Roche, Stiefel, Dermik • Acknowledgements: • Canadian Acne Study Group: Richard Thomas, Yves Poulin, Aditya Gupta, Sheetal Sapra, Wayne Gulliver, Charles Lynde, Rolf Sebaldt

  3. Background 3 hormonal preparations currently indicated in Canada for treatment of acne: • Tri-Cyclen® (Ortho-McNeil) • Alesse® (Wyeth) • Diane-35® (Berlex) There are no clinical trials comparing their relative effectiveness

  4. Objective • To determine the relative effectiveness of these 3 hormonal agents in treatment of acne • To evaluate the effect of hormonal treatment on acne-specific quality of life

  5. Methods I Data from Canadian acne epidemiological survey (observational study ) • New acne patients • Referred to 7 participating dermatologists • Clinical evaluations • IGA, Leeds score, Acne-QoL™ • Treatment: usual clinical practice

  6. Methods II Relative effectiveness evaluated in 2 ways: • Retrospectively - patient responses to questions on effectiveness of previous hormonal therapy • Prospectively - evaluation of outcomes after at least 4 months of treatment

  7. Retrospectivephase - inclusion • Females • Prior use of only one of the hormonal treatments for acne • No prior use of oral isotretinoin

  8. Retrospective phase - results • N= 91 • No difference between groups: • Mean age • Duration of acne • Duration of treatment

  9. Effectiveness ratings • 1. Patient responses converted numerically with higher numbers = greater effectiveness • Proportion of patients rating treatment as moderate-extremely effective

  10. Prospective phase Inclusion criteria • females; • no history of oral isotretinoin use • only one hormonal treatment prescribed at visit 1 or 2 • no other hormone treatments within 2 months of visit 1 • if hormone started at visit 1, this was not changed at visit 2 • Visit 3 (6 month) data available • Minimum compliance of 75%

  11. Acne-QoL™ (with permission from Merck & Co.)

  12. Prospective phase - results • Prospective evaluation performed only for the Diane-35® cohort (N=17) • Insufficient sample sizes for Tricyclen® and Alesse® cohorts (N=1 each)

  13. Results: Acne-QoL™ • total score improvement of 19% (P = 0.017) • improvement in all 4 domains: • Self-perception • Symptoms (P < 0.05) • Emotional • Socialization (P = 0.24)

  14. Results: Prospective analysis • Patient rating treatment as moderate-extremely effective: • 12/17 (71%) • Objective improvement (Leeds, IGA) • 12/17 (71%)

  15. Summary Patients previously treated with one of the 3 hormonal preparations, ranked Diane-35 as the most effective. Patients treated with Diane-35 demonstrated improvement in acne symptoms and acne-related emotional and self-perception domains

  16. Study Limitations • Retrospective study • Recollection bias: comparator cohorts and sample size should minimize confounding • Prospective analysis • lack of a cohort comparator group • completion of Acne-QoL before medical encounter should reduce pre-bias of responses • results represent usual clinical practice of combining topical treatments with Diane-35

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