A prospective, randomized, evaluator- and subject blinded, multi-center investigation to assess efficacy and safety of three different dosages of the same injection pattern of LetibotulinumtoxinA in the treatment of moderate and severe horizontal forehead lines

Moderate and severe horizontal forehead lines.

Response - defined as an improvement of ≥ 1 point in CDFLAS score compared to baseline, measured at maximum eyebrow elevation, based on Blinded Evaluating Investigator’s in-clinic assessment - at 4 weeks post treatment (Visit 2).

CDFLAS scores at maximum eyebrow elevation, based on Blinded Evaluating Investigator’s in-clinic assessment at Baseline (Screening - Visit 0) and 4, 12, 16, 20 and 24 weeks post treatment (Visit 2 to Visit 6)., Response – defined as an improvement of ≥ 1 point in CDFLAS score compared to baseline, measured at maximum eyebrow elevation, based on Blinded Evaluating Investigator’s in-clinic assessment at 12, 16, 20 and 24 weeks post treatment (Visit 3 to Visit 6)., Pronounced Response – defined as an improvement of ≥ 2 points in CDFLAS score compared to baseline, measured at maximum eyebrow elevation, based on Blinded Evaluating Investigator’s in-clinic assessment at 4, 12, 16, 20 and 24 weeks post treatment (Visit 2 to Visit 6)., Score Response – defined as CDFLAS score 1 or 2, measured at maximum eyebrow elevation, based on Blinded Evaluating Investigator’s in-clinic assessment at 4, 12, 16, 20 and 24 weeks post treatment (Visit 2 to Visit 6)., Skin displacement (ability to elevate the eyebrow in mm) at maximum eyebrow elevation, compared to Baseline (Visit 0 or Visit 1), based on blinded 3D surface imaging measurements at 4, 12, 16, 20 and 24 weeks post treatment (Visit 2 to Visit 6)., The extent of subject’s satisfaction with the overall outcome of the treatment as selfassessed by the blinded subject using the Face-Q (TM) Questionnaire “Satisfaction with Outcome” at 4, 12, 16, 20 and 24 weeks post treatment (Visit 2 to Visit 6)., The extent of subject’s appearance appraisal of the forehead and eyebrows compared to Baseline (Screening – Visit 0) as self-assessed by the blinded subject using the Face-Q (TM) Questionnaire “Appearance Forehead and Eyebrows” at 4, 12, 16, 20 and 24 weeks post treatment (Visit 2 to Visit 6), The extent of subject’s appearance appraisal of forehead lines compared to Baseline (Screening – Visit 0) as self-assessed by the blinded subject using the Face-Q (TM) Questionnaire “Appearance: Lines Forehead” at 4, 12, 16, 20 and 24 weeks post treatment (Visit 2 to Visit 6).

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Austria, Germany