SS-02   PANEL REVIEW OF GLOBAL PHOTOGRAPHS AS A POTENTIAL PRIMARY ENDPOINT IN CLINICAL TRIALS OF 5% TOPICAL MINOXIDIL IN PATTERN HAIR LOSS

EA Olsen, DA Whiting, J. Miller, R. Savin, W. Canfield, D. Canfield Duke University Medical Center, Durham, NC, USA.

Panel review of global photographs has been used as a secondary endpoint in clinical trials of hair growth promoters in men and women with pattern hair loss (MPHL and FPHL respectively), the primary endpoint being target area hair counts. However, global photographs may be a preferred primary endpoint for 1) FPHL and 2) in areas of the scalp where a clipped target area would be a deterrent to subject participation. In this study, 352 men with vertex patterns 3, 4, 5 or 6 MPHL aged 18 to 49 were treated with 5% or 2% topical minoxidil or placebo bid x 48 weeks in a 2:2:1 ratio. Seven hundred sixty one women aged 18 to 49 with Ludwig I or II FPHL were treated with 5% topical minoxidil, 2% topical minoxidil or placebo bid x 48 or 52 weeks. Retrospective assessments were performed to rate change in hair growth from baseline in the vertex balding area (male) and mid-frontal scalp (male and female) at 16 and 48 weeks. Standardized, serialized global photographs were taken using a stereotactic device to register patient position and camera angle. Paired slides were reviewed by 3 board certified dermatologists blinded to treatment, study center and patient. Hair growth was rated on a 7-point scale from -3 (greatly decreased) to +3 (greatly increased). Validation of the panel review of global photographs, correlation with prior target area hair count data in the same cohorts of subjects and correlation of hair growth results in different parts of the scalp will be reported and discussed.