Clinical Trial: Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomised, Double-blind, Placebo-controlled Trial of FOL-005 to Investigate Clinical Safety and Effect on Hair Growth in Healthy Volunteers
Brief Summary: A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a multiple dose (MD) part.
Detailed Summary:
SAD part:
A total of 3 weeks dosing, the two lowest concentrations in week 1, dose 3 at week 2 and finally dose 4 at week 3.
MD part:
In total 12 weeks of dosing where group A will be dosed twice weekly and group B three times weekly
Each injection will be administered into one of five of the six randomized areas (10 cm apart, left and right side) from the subject's defined investigational skin areas. One area will be completely untreated.
Sponsor: Follicum AB
Current Primary Outcome: Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2 [ Time Frame: 3 months ]
- Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs [ Time Frame: 3 months ]
- Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Follicum AB
Dates:
Date Received: May 16, 2016
Date Started: January 2016
Date Completion: March 2017
Last Updated: June 3, 2016
Last Verified: June 2016
