A randomized, placebo controlled, double-blind study to evaluate the efficacy of topical formulations in male subjects with androgenetic alopecia
- Conditions
- The study will be performed in male subjects with Norwood/Hamilton grades III - IV, androgenetic alopecia.
- Registration Number
- EUCTR2005-003901-10-DE
- Lead Sponsor
- eosil Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 70
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: <br><br>• to assess the tolerability of NEOSH-101 when administered topically in subjects with androgenetic alopecia.<br><br>• global assessment of hair growth by the physician.<br>;Primary end point(s): The primary efficacy endpoint is the change of hair density.
- Secondary Outcome Measures
Name Time Method