This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the treatment of alopecia areata on the eyebrows.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
13
Ointment containing LEO 124249
Ointment without active ingredients
Investigational site
Aarhus, Denmark
Investigational site
Gentofte Municipality, Denmark
Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth.
The percentage area of the identified left and right eyebrow area and left and right region of interest (ROI) covered by hair growth will be scored according to the following: 1-10 % - 1 11-20 % - 2 21-30 % - 3 31-40 % - 4 41-50 % - 5 51-60 % - 6 61-70 % - 7 71-80 % - 8 81-90 % - 9 91-100 % - 10
Time frame: baseline to week 12
Treatment emergent AEs (including AEs relating to local tolerability)
Time frame: baseline to week 12
Degree of response in change from baseline to Week 12 for ASoverall L+R
Complete response - ≥ 8 Partial response - 4-\<8 Minimal response - 1-\<4 No response - \<1
Time frame: baseline to Week 12
Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score
Is the appearance of the eyebrows cosmetically normal and acceptable? Yes - 1 No - due to insufficient regrowth area - 2 No - due to insufficient density - 3 No - due to uneven distribution - 4 No - due to other reason (explain, including combination of the above) - 5
Time frame: baseline to Week 12
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