Patient reported outcomes: Effectiveness of hormonal treatments for acne

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Patient reported outcomesEffectiveness of
hormonal treatments for acne

• Jerry Tan MD, FRCP1
• Karen Y. Fung PhD2
• 1University of Western Ontario and
• 2University of Windsor, Windsor, Ont.

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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

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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

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Objectives of treatment

• Relief of signs and symptoms
• Limiting structural or functional deterioration
• Prevention of complications
• Maintaining comfort, dignity and/or preserving
  self-esteem
• Cure or remission

Sackett DL, Haynes RB, Tugwell P. Clinical
Epidemiology A Basic Science for Clinical
Medicine. 1985.
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Objectives of treatment as applied to Acne

• Reduction in active lesions
• Prevention of scars
• Reducing psychosocial impact
• Cure or remission

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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

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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

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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

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Retrospective phase - inclusion

• Females
• Prior use of only one of the hormonal treatments
  for acne
• No prior use of oral isotretinoin

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Retrospective phase - results

• N 91

• No difference between groups
• Mean age
• Duration of acne
• Duration of treatment

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Effectiveness ratings

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

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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

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Acne-QoL
(with permission from Merck Co.)
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Prospective phase - results

• Prospective evaluation performed only for the
  Diane-35 cohort (N17)
• Insufficient sample sizes for Tricyclen and
  Alesse cohorts (N1 each)

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Results Acne-QoL

• total score improvement of 19
• (P 0.017)
• improvement in all 4 domains
• Self-perception
• Symptoms (P lt 0.05)
• Emotional
• Socialization (P 0.24)

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Results Prospective analysis

• Patient rating treatment as moderate-extremely
  effective
• 12/17 (71)
• Objective improvement (Leeds, IGA)
• 12/17 (71)

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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

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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