The study will be performed in male subjects with Norwood/Hamilton grades III - IV, androgenetic alopecia.
Conditions
Interventions
Product Name: NEOSH-101
Product Code: NEOSH-101
Pharmaceutical Form: Spot-on solution
INN or Proposed INN: not issued
Current Sponsor code: NEOSH-101
Other descriptive name: C-3900, PSI, Proteasome In
Sponsors
Neosil Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a subject in the study: • Caucasian men, aged 18 to 60 years; • Norwood/Hamilton grades III - IV, androgenetic alopecia (with thinner hair in the vertex area); • healthy skin on the scalp; • the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; • normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant for the study participation; • written informed consent obtained; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are to be excluded from the study when one or more of the following conditions are met: • previous surgical correction of scalp hair loss; • hair loss due to disease/drug treatment; • subjects whose scalp is occluded regularly, eg, hair loss necessitates the wearing of a wig or hat or the subject has to wear a hat for work; • clinically significant abnormalities in clinical chemistry, haematology or urinalysis results; • serological evidence of a fresh hepatitis A and/or B and/or C infection or hepatitis B and/or C infection or treatment during the last three years; • serological evidence of HIV infection; • evidence of drug or alcohol abuse; • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; • participation in another clinical trial involving pharmaceutical products in the four weeks preceding the study; • known allergic reactions to components of the study preparations or hair dye used to color the measurement area; • treatment with systemic or locally acting medications which might counter or influence the study aim (eg, treatment with minoxidil solution within the last six months; treatment with finasteride within the last 12 months, treatment with other hair growth products within the last three months). • in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, eg, due to probable non-compliance or inability to understand the study and give adequately informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of NEOSH-101 compared to its vehicle in stimulating hair growth in male subjects with androgenetic alopecia.;Secondary Objective: The secondary objectives are: • to assess the tolerability of NEOSH-101 when administered topically in subjects with androgenetic alopecia. • global assessment of hair growth by the physician. ;Primary end point(s): The primary efficacy endpoint is the change of hair density. | — |
Countries
Germany
Outcome results
None listed