Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
270
Trial Sponsor
Clinical Trial Start Date
July 2, 2018
0Primary Completion Date
January 21, 2019
0Study Completion Date
January 21, 2021
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Biological0
Other0
Intervention Name
Phosphate Buffered Saline0
Hair Stimulating Complex (HSC)0
Interventional Trial Phase
Phase 10
Participating Facility
Official Name
Phase 1, Randomized, Double-Blind, Vehicle-Controlled Study of Safety and Tolerability of Hair Stimulating Complex (HSC) in Female Subjects With Female Pattern Hair Loss0
Last Updated
February 21, 2019
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Participant0
Outcomes Assessor0
Investigator0
Care Provider0
Study summary
This double-blind placebo-controlled study will assess the tolerability, feasibility, and pharmacodynamics of intradermal Hair Stimulating Complex (HSC) in up to 18 of 27 women with Ludwig 1 or 2 classification or the Savin Frontal classification of hair loss. Safety measures include vital signs, dermatological examination of the scalp, pre- and post-dose blood and urine collection, as well as Investigator Global Assessments and subject self assessments throughout the 22-week study.
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