Integrated exploratory phase 1/2a study, double-blind, randomized, controlled to evaluate the Safety and Efficacy of FTP-002 / FTP-501 combination in the treatment of glabellar lines

glabellar lines.

Part1: • Percentage of responders with at least +1 grade of improvement from baseline on ILA at each post-treatment visit (at maximum frown and at rest)., Part 1: • Percentage of responders with at least +1 grade of improvement from baseline on SSA at each post-treatment visit (at maximum frown and at rest)., Part 1: • Percentage of responders with at least +2 grade of improvement from baseline on ILA at each post-treatment visit (maximum frown and at rest)., Part 1: • Percentage of responders with at least +2 grade of improvement from baseline on SSA at each post-treatment visit (maximum frown and at rest)., Part 1: • Duration of treatment response based on the ILA at maximum frown (from D1 injection to return to baseline level) (for responders with at least +1 grade improvement from baseline)., Part 1: • Duration of treatment response based on the ILA at maximum frown (from D1 injection to return to baseline level) (for all participants where non-responders are treated as duration 0)., Part 1: • Duration of treatment response based on the ILA at rest (from D1 injection to return to baseline level) (for responders with at least +1 grade improvement from baseline)., Part 1: • Duration of treatment response based on the ILA at rest (from D1 injection to return to baseline level) (for all participants where non-responders are treated as duration 0)., Part 2: o Duration of treatment response based on the ILA at maximum frown (from D1 injection to return to baseline level) (for responders with at least +1 grade improvement from baseline).

o Percentage of responders with at least +1 grade of improvement from baseline on ILA at maximum frown at 6 months, o Percentage of responders with at least +1 grade of improvement from baseline on ILA at each post-treatment visit (at maximum frown and at rest)., o Percentage of responders with at least +1 grade of improvement from baseline on SSA at each post-treatment visit (at maximum frown and at rest)., o Percentage of responders with at least +2 grade of improvement from baseline on ILA at each post-treatment visit (maximum frown and at rest)., o Percentage of responders with at least +2 grade of improvement from baseline on SSA at each post-treatment visit (maximum frown and at rest)., o Percentage of responders with a severity grade of “none” or “mild” (maximum frown and at rest) on ILA using each post-treatment visit., o Response to treatment as achieved by a score of “very much improved” or “much improved” or “Improved” on the participant’s GAIS at each post-treatment visit., o Time to onset of treatment response with at least +1 improvement from baseline of ILA at maximum frown and at rest (Day 1 through Day 8)., o Duration of treatment response based on the ILA at maximum frown (from D1 injection to return to baseline level)., o The duration of treatment response based on the ILA at rest (from D1 injection to return to baseline level)., o The duration of treatment response based on the ILA at rest (from D1 injection to return to baseline level)., o The duration of treatment response based on the SSA at maximum frown (from D1 injection to return to baseline level)., o The duration of treatment response based on the SSA at maximum frown (from D1 injection to return to baseline level)., o The duration of treatment response based on the SSA at rest (from D1 injection to return to baseline level)., o The duration of treatment response based on the SSA at rest (from D1 injection to return to baseline level)., o Area under the curve (AUC) of mean score of GL severity at maximum frown and at rest by ILA., o AUC of mean score of GL severity at maximum frown and at rest by SSA.

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