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 Acknowledgements: Canadian Acne Study Group: Richard Thomas, Yves Poulin, Aditya Gupta, Sheetal Sapra, Wayne Gulliver, Charles Lynde, Rolf Sebaldt

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

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

Objectives of treatment as applied to Acne Reduction in active lesions Prevention of scars Reducing psychosocial impact Cure or remission

Objective 1. To determine the relative effectiveness of these 3 hormonal agents in treatment of acne 2. To evaluate the effect of hormonal treatment on acne-specific quality of life

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

Methods II Relative effectiveness evaluated in 2 ways: 1. Retrospectively - patient responses to questions on effectiveness of previous hormonal therapy 2. Prospectively - evaluation of outcomes after at least 4 months of treatment

Retrospective phase - inclusion Females Prior use of only one of the hormonal treatments for acne No prior use of oral isotretinoin

Retrospective phase - results N= 91 No difference between groups: Mean age Duration of acne Duration of treatment Tricyclen 36 Alesse 11 Diane-35 44

Effectiveness ratings PreparationNEffectiveness rating 1 Proportion rating 2 Tricyclen % Alesse % Diane % 1. Patient responses converted numerically with higher numbers = greater effectiveness 2.Proportion of patients rating treatment as moderate-extremely effective

Prospective phase Inclusion criteria 1. females; 2. no history of oral isotretinoin use 3. only one hormonal treatment prescribed at visit 1 or 2 4. no other hormone treatments within 2 months of visit 1 5. if hormone started at visit 1, this was not changed at visit 2 6. Visit 3 (6 month) data available 7. Minimum compliance of 75%

Acne-QoL™ DomainItem Field Self perception Feeling unattractive Feeling embarrassed Feeling self-conscious Dissatisfied with appearance Self-confidence (negatively affected) Emotional Feeling upset Annoyed about time spent cleaning and treating face Concern about not looking your best Concern about acne medication not working fast enough Bothered by need to have medication and cover-up available Social Concern about meeting new people Concern about going out in public Problems socializing Problems interacting with the opposite sex Symptoms Bumps on your face Bumps full of pus on face Scabbing from facial acne Concern about scarring from facial acne Oily facial skin (with permission from Merck & Co.)

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)

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)

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

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

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