A Phase 2 Multicenter, Randomized, Placebo- and Comparator Controlled, Double-Blind Parallel Group Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Me

• Conditions: The study will be performed in male subjects with androgenetic alopecia, Norwood -Hamilton grades III - IV.; MedDRA version: 8.1Level: LLTClassification code 10001760Term: Alopecia

• Registration Number: EUCTR2006-002757-72-DE
• Lead Sponsor: eosil Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

All of the following criteria have to be met for inclusion of a subject in the study:
•Caucasian men, aged 18 to 49 years;
• written informed consent obtained.

•Norwood/Hamilton grades III - IV, androgenetic alopecia (with thinning hair in the vertex area);
•healthy skin on the scalp;
•the physical examination must be without disease findings unless the investigator considers a physical examination abnormality to be irrelevant to the outcome of the study;
•normal clinical laboratory values unless the investigator considers an abnormality to be clinically irrelevant for the study participation;
•subjects either not of reproductive potential (e.g. vasectomy, documented infertility) or use adequate contraception, defined in men as a condom + spermicidal gel or foam or abstinence throughout the duration of the study.
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

concomitant dermatologic or medical condition(s) which may interfere with the investigator’s ability to evaluate the subject’s response to the study drug;
•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;
•evidence of drug or alcohol abuse;
••treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study day 1, finasteride treatment in the 12 months prior to study day 1, or treatment with other investigational hair growth products in the 6 months prior to study day 1;
•previous treatment with NEOSH101;

•donation of blood or plasma to a blood bank or in a clinical study (excluding a Screening visit) within 30 days of study day 1;
•major surgery within 1 month of study day 1;
•history of malignancy not in remission for at least 5 years excluding basal cell carcinoma and nonperiorificial squamous cell carcinoma of the skin;
•history of untreated or poorly-controlled hypertension, myocardial infarction, or other clinically significant cardiovascular disease history;
•another active intercurrent infection or any poorly controlled medical condition;
•a history of hypersensitivity or allergic reactions to minoxidil, propylene glycol or ethanol or to any ingredient in the vehicle formulation, or to hair dye used to tattoo the treatment area;
•if the subjects have a partner who is pregnant or lactating, or who intends to become pregnant during the study period;
•if the subjects are institutionalized because of legal or regulatory order;
•any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in, or complete, the trial or which places the subject at undue risk.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified