B2.2 GLOBAL EVALUATION OF HAIR LOSS IN MALE ANDROGENETIC ALOPECIA : EUROPEAN (EU) TRAINING AND VALIDATION VERSUS US EXPERTS.

Sandraps E, Herbaut D, Lelubre P, Leroy T, Van Neste D.

Skinterface, Tournai, Belgium

Global evaluation of hair loss in male subjects affected by androgenetic alopecia has been proposed as a means for monitoring of changes over time including placebo controlled drug efficacy studies. Because of the potential impact of subjectivity (e.g. placebo effect) of clinical investigators, global photographs (GPs) have been introduced as a more objective record. Examination of paired before and after pictures and rating on a 7-point scale (from greatly decreased -3 to greatly increased +3) has been historically introduced by US experts¹.

Based on published GPs and original GPs obtained at our clinical research facility, we developed a training set in order to allow EU observers to practice and compare with ratings by the US experts. After training with the 7-point scale, there was a positive correlation between 3 US and 3 EU ratings (n=52 paired images from 35 different subjects, r= 0.795). The results of a test-retest evaluation was performed on 18 paired images from the initial image collection by the 3 EU experts. Correlation r= 0.806 and identical scores in 78% of cases documents a reproducibility similar to the single one US expert published data (119 subjects, re-test correlation 0.76 with 75% identical duplicate ratings¹).

17 subjects taken from a placebo controlled trial had GPs at 6 and 12 months. The average difference between an efficacious drug treatment and the placebo were almost similar in the US (0.833) as in the EU (0.689) expert panels.

We also trained the EU experts in performing the scalp coverage scoring (SCS) a novel system for global evaluation of scalp hair in vivo and on GP². SCS was performed on single images (randomised as to time and treatment) taken from the same set of 17 paired GPs. This showed a between group difference of 0.055 at 6 months and 0.201 at 12 months i.e. 5% improved coverage in favour of the active group.

In conclusion, after completion of a study, US and EU experts seem equally valuable in comparing before-after GPs. SCS cannot only be used on GPs but may support the clinical investigator during efficacy evaluation in real time during the trial.

References

¹ Kaufman et al. Reproducibility of global photographic assessments of patients with male pattern baldness in a clinical trial with finasteride. J Invest Dermatol 1995; 104/4:659.(abstract) 

² Sandraps et al. Validation and clinical relevance of a novel scalp coverage scoring (SCS) method. In: Van Neste D, Blume-Peytavi U, Grimalt R, Messenger A, eds. Hair Science and Technology. Tournai-Belgium: Skinterface sprl, 2003:255-270